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Info

Information

Note

Important information and warnings

DELETE

Windows function, e.g. Delete

<xxxxxxxx>

Syntax for placeholders.
Placeholders are written between < > characters.

>>

Reference to a further chapter or document.

Path (e.g. Control > Panel > System > Remote).

Italic

Windows window text

underlined

Input during installation

The representation refers only to a part of the user interface.

Info

In the interest of our customers, we reserve the right to make changes based on technical advances. Therefore, schematics, descriptions and scope of delivery may be changed without prior notice. This manual is valid as of version 2017.

Expand
titleBeschränkte Garantie und Haftungsbeschränkungen

Liability

  • ELPRO-BUCHS AG does not accept any liability for direct, indirect, special, incidentally occurring, randomly occurring or subsequent damage or losses including lost profit or data resulting from the use of their data loggers, sensors, accessories, software products or information from the documentation.

  • ELPRO-BUCHS AG does not bear any responsibility for the installation of the software products.

  • ELPRO-BUCHS AG does not provide any guarantees, either explicit or implicit, regarding the usability or suitability of their products for a specific purpose.

  • In the interest of our customers we reserve the right to make changes and discontinue the product on the basis of technical advancement. For this reason, functionalities, charts, descriptions, and scopes of supply can be modified without prior notification.

  • As individual countries or states do not permit the concept of an implicit warranty or a liability disclaimer for incidental or subsequent damage, the restrictions and disclaimers may not apply to all customers. If one of the provisions of this warranty is declared by a competent court to be invalid or not enforceable, this does not affect the validity or enforceability of the remaining provisions.

  • ELPRO-BUCHS AG does not accept any liability for transport damage.

  • In general the statutory regulations of Switzerland apply. The place of jurisdiction is the district court of Werdenberg-Sarganserland.

Guarantee

  • The guarantee obligations of ELPRO-BUCHS AG are limited to reworking, reimbursement of the purchasing price, repair free of charge or the replacement of a faulty product that is returned within the guarantee period to ELPRO-BUCHS AG or an approved reseller of ELPROBUCHS AG.

  • There is no obligation to provide on-site customer support by an employee of ELPRO-BUCHS AG.

  • The guarantee is only applicable to the original purchaser or end user and customer of an approved reseller of ELPRO-BUCHS AG.

  • Resellers approved by ELPRO-BUCHS AG are not authorized to enter into any extended or different guarantee obligations in the name of ELPRO-BUCHS AG.

  • ELPRO-BUCHS AG provides a guarantee of 24 months on the following new products:

    • Data loggers

    • Holders

    • Accessories except probes and third party products

  • This guarantee is valid for material faults or production faults.

  • ELPRO-BUCHS AG provides a guarantee of 6 months for the following products and services:

    • All service work and repair

    • Temperature sensor

    • Humidity sensor

  • ELPRO-BUCHS AG provides a 90 day guarantee that the medium on which the software product is supplied is free from material and processing faults under normal conditions. All main items of the software product comply with the operating instructions and the information in the help file.

  • The guarantee does not apply to consumables, disposable batteries or any other product that ELPRO-BUCHS AG deems to be:

    • Misused

    • Modified

    • Replaced by an incorrect product

    • Or damaged by accident or operating or handling conditions that are not compliant with specifications.

  • Wear, cable breakage and corrosion are not covered by the guarantee.

  • ELPRO-BUCHS AG provides the guarantee period of the manufacturer for third party products.

  • ELPRO-BUCHS AG only provides a guarantee and customer support for discontinued products for a limited period.

  • Repair work covered by the guarantee is solely carried out at the works (ELPRO-BUCHS AG) or by an agent approved by the works.

  • ELPRO-BUCHS AG does not offer any guarantee for the standard or SCS calibration of the data loggers and probes. The stated data correspond to the situation during the calibration process.

Software

  • The software products of ELPRO-BUCHS AG are subject to internal quality requirements and are validated regularly at the works. In the event of program errors, circumvention of the error is regarded as constituting its elimination.

  • Software manuals do not contain either instructions on basic operation of a computer or the basic functions of the Windows® operating system.

  • For information on the operation of the computer or the operating system please refer to the applicable computer manuals.

  • 21 CFR 11 compliance see: 20140815 Impact of CRF 21 Part 11 on elproMONITOR. This document is obtainable from ELPRO-BUCHS AG

Data loggers, sensors and accessories

  • ELPRO-BUCHS AG applies the highest quality standards during production of the data loggers and their accessories as well as a certified quality management system in compliance with ISO 9001.

  • For information on operation of the data loggers and their accessories please refer to the respective product documentation.

  • During the installation of data loggers, probes and accessories, compliance with the locally valid installation regulations is mandatory.

  • When used in potentially explosive atmospheres, the zone category and the application and safety instructions of ELPRO-BUCHS AG must be complied with.

  • In the event of a guarantee claim, customers receive a repair cost estimate from ELPRO-BUCHS AG to obtain the corresponding consent before starting work.

  • The customer will bear the transport costs incurred for any repairs carried out by ELPRO-BUCHS AG. The DAP (value added tax) is borne by ELPRO-BUCHS AG.

  • ELPRO-BUCHS AG reserves the right to invoice the customer for costs incurred for repair/part replacement.

  • After repair work the product is returned to the purchaser, who will be charged with the return shipping costs (FOB shipping point).

Trademarks

  • All stated company and product names and their trademarks are the protected property of the respective owner.

Note

CHANGES OR MODIFICATIONS TO THIS PRODUCT WILL VOID THE ETSI / FCC APPROVAL TO OPERATE THIS PRODUCT. THIS PRODUCT COMPLIES WITH PART 15 OF THE FCC REGULATIONS AND RSS-210 INDUSTRY CANADA. OPERATION IS SUBJECT TO THE FOLLOWING TWO CONDITIONS: (1) THE PROUDUCT MUST NOT CAUSE HARMFUL INTERFERENCE. (2) THE PROUDUCT MUST ACCEPT ANY INTERFERENCE RECEIVED, INCLUDING INTERFERENCE THAT MAY CAUSE UNDESIRED OPERATION.

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  • This product is subject to CE marking.

  • The manufacturer guarantees the conformity of this product to the corresponding directives: EN 61000-6-2 : 2001 and EN 61000-6-4 : 2001

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  • FCC ID: Z45-E11645398

  • IC: 9954A-E11645398

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  • This product must be disposed of in accordance with WEEE (Waste electrical and electronic equipment, 2002/ 96/EC)!

Expand
titleInhaltsverzeichnis
Table of Contents

1. System Requirements

>> elproMONITOR Software - System Requirements
Info

elproMONITOR system requirements

Info

This manual is based on Windows Server 2019 (ENU) and SQL Server 2019 (ENU). If you use other Windows versions, some details may vary from the instructions in this manual.

Note

For Windows Server and client oprating systems like Windows 10/11 only English and German are supported!

1.1. Supplied Program Packets

The list below contains the software packets supplied.

SW Module

Description

Directory

elproMONITOR Service

Service which reads the measuring values out of the loggers and writes them to the database.

Program Files\elproMONITOR <VersionNumber>\MonitorService\

elproMONITOR Web Application

elproMONITOR web application called up from the browser.

websites\elproMONITOR <version number>\WebClient

elproMONITOR SQL Script

SQL script which is needed to create the schema for the elproMONITOR database.

Setup Files\SQLScripts\CreateMonitorSchema.sql

Management Tool

The Management Tool is needed to create the configuration XMLs and to enter and activate the license key.

Program Files\elproMONITOR ManagementTool <Version Number>

MSVC Redistributables

Redistributables which are needed to execute elproMONITOR.

Setup Files

elproEVENT Application

The elproEVENT application.

Program Files\elproEVENT <Version Number>\Application Folder

elproEVENT SQL Script

SQL script which is needed to create the schema for the elproEVENT database.

Setup Files\SQLScripts\CreateEventSchema.sql

elproUSER Service

Service that uses rights and user management.

Program Files\elproUSER<Versionsnumber>\UserService

elproUSER SQL Script

SQL script which is needed to create the schema for the elproUSER database.

Setup Files\SQLScripts\CreateUserSchema.sql

RabbitMQ Service

Service, which communicates with the ECOLOG-PRO Radio Module via MQTT protocol.

Setup Files\RabbitMQ 3.12.10
See >> 4.6. RabbitMQ Installation

ProModulConfigurator

Configuration tool for editing the ECOLOGPRO modules

Program Files

RBRConfigurator

Config-Tool zum bearbeiten der ECOLOG-PRO RBR Modules

Program Files

3. Definition of Target System

Before you start the installation, define how the target system should look like.

3.1. Default Proposal to Create New Users

User

Access Rights

elproMonitorDBUser

Dedicated user for the elproMONITOR application database. Has read/write rights to this database.

elproEventDBUser

Dedicated user for the elproEVENT application database. Has read/write rights to this database.

elproUserDBUser

Dedicated user for the elproUSER application database. Has read/write rights to this database.

 In addition, read-only rights must be granted for the following tables in the elproMONITOR and elproEVENT application databases.

  • Applications

  • FunctionNames

  • Functions

  • Languages

  • Resources

elproUser

Optionally, you can create a Windows user.

Is the executing user of the elproMONITOR Service, elproEVENT, and elproUSER.

3.2. Default Proposal to Create New Databases

Database

Description

elproMONITOR

Database for the elproMONITOR application.

elproEVENT

Database for the elproEVENT application.

elproUSER

Database for the elproUSER application.

3.3. Default Proposal to Create Directories

Name

Description

Default Path Proposal

Program Directory

Programs are installed in the default program directory.

C:\Program Files\ELPRO

Configuration Directory

Stores database access configurations and licensing data

C:\ProgramData\ELPRO\License

Web Application Directory

For safety reasons, we urgently advise you to install the web client application in the official web publication directory.

It is possible to install the web application together with IIS on a separate computer. The installation directory relates to this computer

C:\ProgramData\ELPRO\Websites

4. Installing the Basic System

4.1 Server

4.1.1. Server Setup

  • Standard server installation

  • Configure server name

    Control Panel → System → Change Settings → Computer Name → Change

    • Enter new name:
      e.g. MONITOR

4.1.2. Firewall Configuration

4.1.2.1. Activate Remote Desktop Service

  • Remote Desktop
    Control Panel → System → Change settings → Remote → Remote Desktop

    • Allow
      Allow remote connection on this computer only from computers running Remote Desktop with Network Level Authentication.

  • Firewall Rules
    Control Panel → Windows Firewall → Advanced Settings → Inbound Rules

    • Allow
      Remote Desktop - User Mode (TCP-In) Profile Public

4.1.2.2. Allow Ping

  • Firewall Rules
    Control Panel → Windows Firewall → Advanced Settings → Inbound Rules

    • Allow
      File and Printer Sharing (Echo Request - ICMPv4-In)

4.1.2.3. Firewall ports and protocol overview

Name

Windows Firewal Rule

From

To

Port

Protocol

Comments

ECOLOG-NET

Incoming

AppServer

Logger

2101

TCP

n/a

ECOLOG-PRO

Incoming

AppServer

Logger

502

TCP

n/a

ECOLOG-PRO Push

Incoming

AppServer

Logger

1883

TCP/UDP

unencrypted access

ECOLOG-PRO Push

Incoming

AppServer

Logger

8883

TCP/UDP

encrypted access

SMS-Modem

Incoming

AppServer

Modem

10001

TCP

n/a

Website Access

Incoming

WebServer

Clients

80., 81

http

unencrypted access

Website Access

Incoming

WebServer

Clients

443

https

encrypted access

SQL-Instance

Incoming

SQL-Server

AppServer

1433

TCP

Default Instance

SQL-Browser

Incoming

SQL-Server

AppServer

1434

UDP

Named Instance

WcfBaseAddress

Incoming

AppServer

WebServer

8000, 8001

TCP

Webserver is separated

4.1.2.4. Firewall Rules

elproMONITOR WebClient

Should the elproMONITOR WebClient be located on a different server, the port between IIS and Service must be opened on the elproMONITOR Service Machine.

Control Panel → Windows Firewall → Advanced Settings → Inbound Rules → NewRule→Port→TCP, Specific Local Ports: <Service Port (8000 as default)→ Allow Connection → All Profiles
Port 8000

Info

Open Port 8000 only if the webserver is dedicated

Database

If the database is located on a different server, set up the necessary port to allow access.

Control Panel → Windows Firewall → Advanced Settings → Inbound Rules → New Rule → Port → TCP, Specific Local Ports: <Service Port (1433 as default) → Allow Connection → All Profiles
Port 1433

ECOLOG-NET

Open this port for accesses:
New Rule → Port → Tcp, Specific Local Ports: <Service Port (Standard 2101) → Allow Connection → All profiles
Port 2101

ECOLOG-PRO

Open this port for accesses:
New Rule → Port → Tcp, Specific Local Ports: <Service Port (standard 502) → Allow Connection → All profiles
Port 502

ECOLOG-PRO PUSH

Open this port for accesses:

  • New Rule → Port → TCP, Specific Local Ports: <Service Port (standard 1883) → Allow Connection → All profiles
    Port 1883 - TLS unencrypted

  • New Rule → Port → TCP, Specific Local Ports: <Service Port (standard 8883) → Allow Connection → All profiles
    Port 8883 - TLS encrypted

  • New Rule → Port → TCP, Specific Local Ports: <Service Port (standard 5672) → Allow Connection → All profiles
    Port 15672

Info

Open Port 15672 only if RabbitMQ should be available from an external source like client PC

  • New Rule → Port → UDP, Specific Local Ports: <Service Port (standard 1883) → Allow Connection → All profiles
    Port 1883 - TLS unencrypted

  • New Rule → Port → UDP , Specific Local Ports: <Service Port (standard 8883) → Allow Connection → All profiles
    Port 8883 - TLS encrypted

ECOLOG-PRO RBR Configurator

  • New Rule → Port → TCP, Specific Local Ports: <Service Port → Allow Connection → All profiles
    Port 22123

SMS modem

  • New Rule → Port → TCP, Specific Local Ports: <Service Port → Allow Connection → All profiles
    Port 10001

http://msdn.microsoft.com/de-ch/library/ms175043.aspx

4.2 IIS Installation

IIS must be installed on the computer on which the web application is to run.

  • Start Server Manager.

  • Right-click Roles → Add Roles in order to start the Add Roles Wizard.

    • Depending on the version of the Windows Server, select Installation Type Rolebased or feature based installation

  • Select Web Server (IIS).

  • Use the following Settings in the Role services section.
    Web Server
    Common HTTP Features
    Static Content
    Default Document
    Directory Browsing
    HTTP Errors
    Application Development
    ASP.NET (3.5 und 4.5) - only ECOLOG NET relevant
    .NET Extensibility (3.5 und 4.5) - only ECOLOG NET relevant
    ISAPI Extensions
    ISAPI Filters
    Health and Diagnostics
    HTTP Logging
    Request Monitor
    Security
    Request Filtering
    Performance
    Static Content Compression
    Management Tools
    IIS Management Console

Info

NET Framework 7.0 is required. Installation packages of .NET Hosting Bundle and Desktop Runtime are included in the installation package.

4.2.2. Windows Update

  • Execute Windows Update to ensure that all patches are installed for the .NET Framework.

4.3. MS SQL Server

4.3.1. Basic Installation (for example, with MSSQL 2019 Full Version)

  • Start SQL Server Installer.

  • Left-click Installation.

  • Select New SQL Server stand-alone installation.

    • Click through the licensing instructions and confirmations.

  • SQL Server Feature Installation

    • Select
      Database Engine Services
      Management tools – Basic
      Management Tools - Complete

  • Define server instance.
    e.g. Default instance, InstanceID ELPRODBSERVER

  • In the section Server Configuration under Service Account, set the Startup Type of the SQL Server Browser to Automatic.

  • In the section Database Engine Configuration under Server Configuration Authentication Mode, select the option Mixed Mode (SQL Server authentication and Windows authentication) and define a password for “SA” users.

  • Click through to Installation and then close.

  • Start SQL Server Configuration Manager.

  • Navigate to SQL Server Network Configuration Protocols for MSSQLSERVER and check if TCP/IP is set to Enabled.

  • Double-click on TCP/IP to open Properties.

  • a Change to the IP Addresses tab and in the section IP2, check the following settings and adapt, if necessary:
    IP Address: <Server IP address>
    TCP Dynamic Ports: <empty>
    TCP Port: 1433

  • If changes to the settings have been made, save them by clicking Apply.

  • Close SQL Server Configuration Manager and reboot the Windows Server.

4.4. Copy Program and Webclient files

Source directory

Destination directory

Comment

<Setupdirectory>\Program Files\elproMONITOR <Versionnumber>

<Programdirectory>\elproMONITOR <Versionnumber>

<Setupdirectory>\Program Files\elproEVENT <Versionnumber>

<Programdirectory>\elproEVENT <Versionnumber>

<Setupdirectory>\Program Files\elproUSER <Versionnumber>

<Programdirectory>\elproUSER <Versionnumber>

<Setupdirectory>\websites\elproMONITOR

<Webapplicationsdirectory>\elproMONITOR

On the same machine where IIS has been installed.

<Setupdirectory>\websites\elproUSER

<Webapplicationsdirectory>\elproUSER

On the same machine where IIS has been installed.

4.5. Installing Redistributables

4.5.1. Installation MSVC 2013 Redistributables

  • Execute …\Setup Files\MSVC 2013 Redistribuatable\vcredist_x64.exe.

  • Select the checkbox "I agree to the license terms and conditions" and press Install.

  • The redistributable is installed. After installation, confirm with Close.

4.5.2. Installation MSVC 2015 Redistributables

  • Execute directory …\Setup Files\ MSVC 2015 Redistribuatable \vc_redist.x64.exe.

  • Select the checkbox "I agree to the license terms and conditions" and press Install.

  • The redistributable is installed. After installation, confirm with Close.

Anchor
4.6.-RabbitMQ-Installation
4.6.-RabbitMQ-Installation
4.6. RabbitMQ Installation

Find these prerequisite Installation FIle in the Release package or download here:

4.6.1. Install Erlang/OTP

Download the installer and run the exe file. Installer wizard help you through the install process.

4.6.2. Download rabbitmq_message_timestamp plugin

Info

Is no longer necessary with RabbitMQ 3.12.10

4.6.3. Install RabbitMQ

Enable the RabbitMQ Management web interface and MQTT

Code Block
breakoutMode

Note

The configuration of the RabbitMQ database is saved in elproMONITOR SQL.

Therefore, all configurations are re-read and entered into the RabbitMQ database when the service is reinstalled and restarted.

Recommendation to rename the existing folder C:\ProgramData\ELPRO\RabbitMQ to C:\ProgramData\ELPRO\RabbitMQ_Old.

If everything works correctly delete the C:\ProgramData\ELPRO\RabbitMQ_Old folder

4.6.3. Install RabbitMQ

Enable the RabbitMQ Management web interface and MQTT

Code Block
breakoutModewide
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.12.10\sbin\rabbitmq-plugins.bat" enable rabbitmq_management
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.12.10\sbin\rabbitmq-plugins.bat" enable rabbitmq_mqtt
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.12.10\sbin\rabbitmq-service.bat" stop
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.12.10\sbin\rabbitmq-service.bat" start

4.6.4. Apply the advanced configurations

  • Stop the service

Code Block
breakoutModewide
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.12.10\sbin\rabbitmq-service.bat" stop
  • Copy the file RabbitMQ.conf from installation package to destination folder.
    destination folder: c:\Programdata\ELPRO\RabbitMQ

  • Start the service

Code Block
breakoutModewide
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.12.10\sbin\rabbitmq-service.bat" start

4.6.5. Settings to set in elproMONITOR’s database (dbo.Settings table)

Default values are shown below:

  • RabbitMQPortAMQP 5672 unencrypted or 5671 encrypted

  • RabbitMQPortMQTT 1883 unencrypted or 8883 encrypted

4.6.6. Import the RabbitMQ configuration on the management UI

Expand
titleConfiguration file
Code Block
languagejson
{
	"rabbit_version": "3.12.10",
	"rabbitmq_version": "3.12.10",
	"product_name": "RabbitMQ",
	"product_version": "3.12.10",
	"users": [
		{
			"name": "mqtt-anonymous-user",
			"password_hash": "I6aekaYGkw8lzLTd162z123gM9l0komfZLGoVN16yH6tKUNT",
			"hashing_algorithm": "rabbit_password_hashing_sha256",
			"tags": "management"
		},
		{
			"name": "guest",
			"password_hash": "V/VMfaMiD8rqX5XUj/j6MelP0uYZ5wJOvZhNNu/9oMwT5+yl",
			"hashing_algorithm": "rabbit_password_hashing_sha256",
			"tags": "administrator"
		}
	],
	"vhosts": [
		{
			"name": "/"
		}
	],
	"permissions": [
		{
			"user": "mqtt-anonymous-user",
			"vhost": "/",
			"configure": ".*",
			"write": ".*",
			"read": ".*"
		},
		{
			"user": "guest",
			"vhost": "/",
			"configure": ".*",
			"write": ".*",
			"read": ".*"
		}
	],
	"topic_permissions": [],
	"parameters": [],
	"global_parameters": [
		{
			"name": "cluster_name",
			"value": "rabbit@WIN-2KUAD2N2RAI"
		},
		{
			"name": "internal_cluster_id",
			"value": "rabbitmq-cluster-id-orZSP-j34Bgdonr8S46dEw"
		}
	],
	"policies": [],
	"queues": [
		{
			"name": "uplink.module.measurements",
			"vhost": "/",
			"durable": true,
			"auto_delete": false,
			"arguments": {
				"x-queue-type": "classic"
			}
		},
		{
			"name": "uplink.module.others",
			"vhost": "/",
			"durable": true,
			"auto_delete": false,
			"arguments": {
				"x-queue-type": "classic"
			}
		},
		{
			"name": "uplink.bridge",
			"vhost": "/",
			"durable": true,
			"auto_delete": false,
			"arguments": {
				"x-queue-type": "classic"
			}
		}
	],
	"exchanges": [
		{
			"name": "rbr.uplink",
			"vhost": "/",
			"type": "direct",
			"durable": true,
			"auto_delete": false,
			"internal": false,
			"arguments": {}
		}
	],
	"bindings": [
		{
			"source": "rbr.uplink",
			"vhost": "/",
			"destination": "uplink.bridge",
			"destination_type": "queue",
			"routing_key": "~uplink.bridge",
			"arguments": {}
		},
		{
			"source": "rbr.uplink",
			"vhost": "/",
			"destination": "uplink.module.measurements",
			"destination_type": "queue",
			"routing_key": "~uplink.module.measurements",
			"arguments": {}
		},
		{
			"source": "rbr.uplink",
			"vhost": "/",
			"destination": "uplink.module.others",
			"destination_type": "queue",
			"routing_key": "~uplink.module.others",
			"arguments": {}
		}
	]
}

4.6.7. Nice to know: Configure RabbitMQ manually

wide
Expand
titleConfigure RabbitMQ manually - Not a standard installation step
  • Create the new user for the anonymous MQTT connections (change credentials if needed)

Code Block
breakoutMode
rabbitmqctl.bat add_user "mqtt-anonymous-user" "Password1234"
rabbitmqctl.bat set_permissions -p / "mqtt-anonymous-user" ".*" ".*" ".*"
rabbitmqctl.bat set_user_tags "mqtt-anonymous-user" management
Note

This user is set up to be an administrator and has management access. Permissions and tags have to be fine-tuned.

Code Block
Name: rbr.uplink
Type: direct
Durability: durable
Auto-delete: false
Internal: false
Arguments: empty
Name: rbr.uplink.measurements
Type: direct
Durability: durable
Auto-delete: false
Internal: false
Arguments: empty
Code Block
Name: uplink.module.measurements
Type: classic
Durability: durable
Auto-delete: false
Arguments: empty
Name: uplink.bridge
Type: classic
Durability: durable
Auto-delete: false
Arguments: empty
Name: uplink.module.others
Type: classic
Durability: durable
Auto-delete: false
Arguments: empty
Code Block
From exchange: rbr.uplink
Routing key: ~uplink.bridge
Arugments: empty
  • Select the uplink.module.others queue and add the following bindings

Code Block
From exchange: rbr.uplink
Routing key: ~uplink.module.others
Arugments: empty
  • Select the uplink.module.measurements queue and add the following bindings

Code Block
From exchange: rbr.uplink
Routing key: ~uplink.module.measurements
Arugments: empty

Anchor
5.-Datenbanken-einrichten
5.-Datenbanken-einrichten
5. Creating Databases

5.1 Create Application-Specific DB Logins

  • Start SQL Server Management Studio and login to the database as DB Administrator.

  • Create Login names:
    elproMonitorDBUser
    elproEventDBUser
    elproUserDBUser

5.1.2. Procedure to create new Login names

Info

Carry out these 5 steps for each of the three Login names.

  1. Right-click <server name> → Security → Logins → New Login… to open the window to create a new user.

  2. Select the option SQL Server authentication, enter <Login name> under Login name:, and enter a password (e.g. elpro).
    Alternatively select Windows authentication and then select the required Windows User. Finally omit the next two steps.

  3. Untick the following checkbox:

    • User must change password at next login

Note

IF THE OPTION "ENFORCE PASSWORD EXPIRATION" IS SELECTED, IT MAY CAUSE THE APPLICATION TO FREEZE IF YOU FAIL TO CHANGE THE PASSWORD IN GOOD TIME.

4. Left-click on Server Roles and tick the checkboxes for public in the list.

 5. Create login by clicking OK.

5.2. Setting up elproMONITOR

5.2.1. Create the New elproMONITOR Database

  • Start SQL Server Management Studio and login to the database as DB Administrator.

  • Right-click Databases → New Database.

  • Enter the database name under Database name. (e.g. elproMONITOR)

  • If required, change DB Owner and the memory location for the database file and the database logfile (under Path).

  • Create database by clicking on OK.

5.2.2. Create New Main User in elproMONITOR Database

  • Start SQL Server Management Studio and connect to the database as DB Administrator.

  • Right-click <server name> → Databases → <elproMONITOR> → Security → Users → New User… to open the window to create a new user

  • Define the database user on the General page. As login name, use the previously entered, application-specific login name for elproMONITOR.

User type

SQL user with login

User name

elproMonitorDBUser

Login name

elproMonitorDBUser

Default schema

dbo

  • In the list on the Membership page, select the entries db_datareader and db_datawriter.

  • Create User by clicking OK.

5.2.3. Create Database Schema

  • Start SQL Server Management Studio and login to the database as DB Administrator.

  • Double-click on<Setupdirectory>\SetupFiles\SQLScripts\ MonitorSchema3.0.0.sql to open.

  • Click in the window of the open script. Call Query Specify Values for Templates Parameters…(Ctrl+Shift+M) and enter the name of the previously created database. (e.g.: DatabaseName elproMONITOR)

  • Close the Template Parameters window by clicking OK.

  • Click Execute(F5) to execute the script.

Create elproUserDBUser in the elproMONITOR Database and Assign User Rights

  • Start SQL Server Management Studio and log in to the database as a DB Administrator.

    Right-clickthe<servername>folder→Databases→<elproMONITOR>→Security →Users→New User… to open the window for the creation of a new user.

  • Define the database user on the General page. As login name, use the previously entered, application-specific login name for elproUSER.

User type

SQL user with login

User name

elproUserDBUser

Login name

elproUserDBUser

Default schema

dbo

  • On the Securables page, click Search….

  • In the following Add Objects window, select the option Specific objects… and click OK.

  • In the following

    5.2.4 Remove Duplicate Null Measurements (Gap filler)

    • for installing a brand new eM 3.x version with a clean database:
      nothing is required to be run manually after executing CreateSchema.sql as the original issue has been fixed.

    • for freshly upgrading an existing older elproMONITOR installation to 3.x+ version:
      ELPRO.elproMONITOR.RemoveDuplicateNullMeasurements.sql is required to be run manually after executing CreateSchema.sql.

      This script is exactly the same as the one we used for fixing an existing eM 2.2.x installation. This script is part of the installation artifact we create and can be found next to the CreateSchema.sql file and it will delete faulty measure values with timestamp of 1900-01-01 00:01:01.000 and it will also delete faulty NULL measure values where other valid measure values are present.

    5.2.5. Create elproUserDBUser in the elproMONITOR Database and Assign User Rights

    • Start SQL Server Management Studio and log in to the database as a DB Administrator.

      Right-clickthe<servername>folder→Databases→<elproMONITOR>→Security →Users→New User… to open the window for the creation of a new user.

    • Define the database user on the General page. As login name, use the previously entered, application-specific login name for elproUSER.

    User type

    SQL user with login

    User name

    elproUserDBUser

    Login name

    elproUserDBUser

    Default schema

    dbo

    • On the Securables page, click Search….

    • In the following Add Objects window, select the option Specific objects… and click OK.

    • In the following Select Objects window, click top right on the button Object Types…, tick the checkbox in Tables in the new Select Object Types window, and close the window by clicking OK.

    • Back in the Select Objects window, right-click on Browse…. In the new Browse for Objects window appearing, tick the following checkboxes:

      • [dbo].[Applications]

      • [dbo].[FunctionNames]

      • [dbo].[Functions]

      • [dbo].[Languages]

      • [dbo].[Resources]

    • Click OK to close the Browse for Objects and the Select Objects windows.

    • Under Permissions for dbo….: tick the checkbox for Grant for these 5 tables in the following entries:
      Select
      View Definition

    • Create User by clicking OK.

    5.3. Setting up elproEVENT

    5.3.1. Create New elproEVENT Database

    • Start SQL Server Management Studio and login to the database as DB Administrator.

    • Right-click Databases → New Database.

    • Enter the database name under Database name. (e.g.: elproEVENT)

    • If required, change DB Owner and the memory location for the database file and the database logfile (under Path).

    • Create database by clicking OK.

    5.3.2. Create New Main User in elproEVENT Database

    • Start SQL Server Management Studio and log in to the database as a DB Administrator.

    • Right-click the <server name> folder → Databases → <elproEVENT> → Security → Users → New User… to open the window for the creation of a new user.

    • Define the database user on the General page. As login name, use the previously entered, application-specific login name for elproEVENT.

    User type

    SQL user with login

    User name

    elproEventDBUser

    Login name

    elproEventDBUser

    Default schema

    dbo

    • In the list on the Membership page, select the entries db_datareader and db_datawriter.

    • Create User by clicking OK.

    5.3.3. Create Database Schema

    • Start SQL Server Management Studio and login to the database as DB Administrator.

    • Double-click on<Setupdirectory>\Setup Files\SQLScripts\EVENTSchema2015.2.P5.sql to open.

    • Click in the window of the open script. Call Query → Specify Values for Templates Parameters…(Ctrl+Shift+M) and enter the name of the previously created database. (e.g. elproEVENT)

    • Close the Template Parameters window by clicking OK.

    • Click Execute (F5) to execute the script.

    5.3.4. Create elproUserDBUser in the elproEVENT Database

    • Start SQL Server Management Studio and login to the database as DB Administrator.

    • Right-click the <server name> folder Databases <elproEVENT> Security Users New User… to open the window for the creation of a new user.

    • Define the database user on the General page. As login name, use the previously entered, application-specific login name for elproUSER.

    User type

    SQL user with login

    User name

    elproUserDBUser

    Login name

    elproUserDBUser

    Default schema

    dbo

    • On the Securables page, click Search….

    • In the following Add Objects window, select the option Specific objects… and click OK.

    • In the following Select Objects window, click top right on the button Object Types…, tick the checkbox in Tables in the new Select Object Types window, and close the window by clicking OK.

    • Back in the Select Objects window, right-click on Browse…. In the new Browse for Objects window application-specific login name for elproUSER.

      • [dbo].[Applications]

      • [dbo].[FunctionNames]

      • [dbo].[Functions]

      • [dbo].[Languages]

      • [dbo].[Resources]

    • Click OK to close the Browse for Objects and the Select Objects windows.

    • Under Permissions for dbo….: tick the checkbox for Grant for these 5 tables in the following entries:
      Select
      View Definition

    • Create User by clicking OK.

    5.4. Setting up elproUSER

    5.4.1. Setting up elproUSER

    • Start SQL Server Management Studio and login to the database as DB Administrator.

    • Right-click Databases → New Database.

    • Enter the database name under Database name. (e.g. elproUSER)

    • If required, change DB Owner and the memory location for the database file and the database logfile (under Path).

    • Create database by clicking OK.

    5.4.2. Create New Main User in elproUSER Database

    • Start SQL Server Management Studio and log in to the database as a DB Administrator.

    • Right-click the <server name> folder → Databases → <elproUSER> → Security → Users → New User… to open the window for the creation of a new user.

    • Define the database user on the General page. As login name, use the previously entered, application-specific login name for elproEVENT.

    User type

    SQL user with login

    User name

    elproUserDBUser

    Login name

    elproUserDBUser

    Default schema

    dbo

    • In the list on the Membership page, select the entries db_datareader and db_datawriter.

    • Create User by clicking OK.

    5.4.3. Create Database Schema

    • Start SQL Server Management Studio and login to the database as DB Administrator.

    • Double-click on<Setupdirectory>\Setup Files\SQLScripts\USERSchema2021.3.P4.sql to open.

    • Click in the window of the open script. Call Query → Specify Values for Templates Parameters…(Ctrl+Shift+M) and enter the name of the previously created database. (e.g. elproUSER)

    • Close the Template Parameters window by clicking OK.

    • Click Execute (F5) to execute the script.

    6. Installation und Konfiguration

    1. The following sections must be executed as Windows Administrator:
      >> 6.1. Setup Windows Event Display for elproEVENT
      >> 6.2. Setting up the elproMONITOR Web Application
      >> 6.3. Setting up the elproUSER Web Application
      >> 6.4 Creating and Configuring Dedicated Windows User

    2. If a dedicated Windows user is created to execute the elproUSER and elproEVENT programs (>> 6.4 Creating and Configuring Dedicated Windows User), the steps from >> 6.5 Configurations Using the elproMONITOR Management Tool can be executed via login with this user.

    Anchor
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    6.1. Setup Windows Event Display for elproEVENT

    • Open Windows Powershell (powershell.exe) (by right-clicking Run as administrator).

    • Enter the following command: New-EventLog -LogName Application -Source "elproEVENT Library"

    Anchor
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    6.2. Setting up the elproMONITOR Web Application

    Anchor
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    6.2.1. Set up elproMONITOR Service

    • As preparation, create the configuration directory.
      e.g. C:\ProgramData\ELPRO\License

    Info

    In newer operating systems, the ProgramData folder is hidden as standard and cannot be selected in Explorer and in the Management Tool. For this, go to Folder Options and change "Hidden files, folders and drives" to "Show".

    • Execute the batch processing file <Programdirectory>\elproMONITOR<Versionnumber>\MonitorService\Install.bat (by right-clicking → Run as administrator).

    • Complete the requests for required values in the prompt. Only enter a name without spaces for Service Name.

    Example for cmd prompt

    Please enter the Service name (no spaces allowed): elproMONITOR
    Please enter the configuration directory path (example C:\ProgramData\ELPRO): C:\ProgramData\ELPRO\License
    Please enter a display name for the service(spaces allowed): elproMONITOR

    • Wait until the installation is complete and the prompt displays the following feedbacks:
      CreationService SUCCESS
      ChangeServiceConfig2 SUCCESS

    Anchor
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    6.2.2.-Web-Client-einrichten-(IIS)
    6.2.2. Set up Web Client (IIS)

    6.2.2.1. Preparation

    • Open file <Webapplicationdirectory>\WebClient\Web.config in Text Editor.
      e.g. C:\programdata\ELPRO\websites\elproMONITOR\WebClient\Web.config

    • Search for Tag forms. Set the value of the associated Attribute name to the Service Name.

    • Additional step if the WebClient is running on a different machine to the Service. (The connection from the web application to the elproMONITOR Service is defined via WcfBaseAddress.)

      • Search for key="WcfBaseAddress". The value of the associated attribute must be adjusted as follows. If the web application and the Service are not being run on the same computer, the IP address must be set to the value of the elproMONITOR Service computer.

    • The default port number (8000) can be optionally changed. If the default port number is changed, this also has to be changed in the elproMONITOR table: Setting entry Keyname WcfBaseAddress.
      e.g. <add key="WcfBaseAddress"value="net.tcp://<Adresse>:<Portnumber>"/>
      <forms cookieless="UseCookies" loginUrl="~/Account/Login" name="elpro-MONITOR" />

    • Save the changes.

    6.2.2.2. Configure IIS

    • Start IIS Manager (inetmgr.exe).

    • Double-click to expand the <System Servername> of the Connections list.

    Info

    If a pop-up window with a query appears at this point, close the window by clicking No.

    • Expand Sites by double-clicking.

    • Delete the entry Default Web Site.

    • Right-click Sites → Add Web Site …

    • Enter a name for the website under Site name: and a path to the web application directory under Physical path:
      e,g, Site name: elproMONITOR, Physical path: C:\programdata\ELPRO\websites\elproMONITOR <VersionNumber>\WebClient

    • The remaining values may be left with the default values.
      Optional: The settings for Type, IP address, Port and Host name can be changed as required, (for example multi-tenant capability across various ports, connection to DNS, etc.)
      Exit the configuration and create new website by clicking OK.

    Info

    The remaining steps can be skipped under Windows Server 2019.

    • Click Application Pools (on left of window).

    • Right-click elproMONITOR Advanced Settings …

    • Change property .NET Framework Version to V4.0 and confirm by clicking OK.

    • Start command prompt with Command Prompt Run as administrator.

    • Enter
      cd C:\Windows\Microsoft.NET\Framework\v4.0.30319

    • Enter
      aspnet_regiis –i

    • Wait for prompt feedback
      Finished installing ASP.NET

    Anchor
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    6.3. Setting up the elproUSER Web Application

    6.3.1. Set up the elproUSER Service

    • As preparation, create the configuration directory.
      e.g.C:\ProgramData\ELPRO\License

    Info

    In newer operating systems, the ProgramData folder is hidden as standard and cannot be selected in Explorer and in the Management Tool. For this, go to Folder Options and change "Hidden files, folders and drives" to "Show".

    • Execute the batch processing file <Programdirectory>\elproUSER<Versionnumber>\Install.bat (by right-clicking → Run as administrator).

    • Complete the requests for required values in the prompt. Only enter a name without spaces for Service Name.

    Example of the command prompt

    Please enter the Service name (no spaces allowed): elproUSER
    Please enter the configuration directory path (example C:\ProgramData\ELPRO): C:\ProgramData\ELPRO\License
    Please enter a display name for the service(spaces allowed): elproUSER

    • Wait until the installation is complete and the prompt displays the following feedbacks:
      CreationService SUCCESS
      ChangeServiceConfig2 SUCCESS

    6.3.2. elproUSER Set up API (IIS)

    6.3.2.1. Preparation

    • Open file <Webapplicationdirectory>\elproUSER API\Web.config in Text Editor.
      e.g. C:\programdata\ELPRO\websites\elproUSER\WebApi\Web.config

    • Additional step if the Web API is running on a different machine to the Service. (The connection from the web application to the elproUSER service is defined via WcfBaseAddress.)

      • Search for key="WcfBaseAddress". The value of the associated attribute must be adjusted as follows. If the web application and the Service are not run on the same computer, the IP address must be set to the value of the elproUSER Service computer.

    • The default port number (8001) can be optionally changed. If the default port number is changed, this must also be changed in the elproUSER table: Setting entry Keyname WcfBaseAddress.
      e.g. <add key="WcfBaseAddress"value="net.tcp://<Adresse>:<PortNumber>"/>

    • Save the changes.

    6.3.2.2. Configure IIS

    • Start IIS Manager (inetmgr.exe).

    • Double-click to expand the <System Servername> of the Connections list.

    Info

    If a pop-up window with a query appears at this point, close the window by clicking No.

    • Expand Sites by double-clicking.

    • Right-click on elproMONITOR → Add Application …

    • Under Alias:, enter a name for the API and under Physical path:, enter the path to the web application directory.
      e.g. Alias: user-api, Physical path: C:\programdata\ELPRO\websites\elproUSER\WebApi

    • Exit the configuration and create the new alias by clicking OK.

    Anchor
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    6.3.3.-elproUSER-Client-einrichten-(IIS)
    elproUSER Set up Client (IIS)

    6.3.3.1. Preparation

    • Open file <Webapplicationdirectory>\elproUSER Client\config.json in Text Editor.
      e.g. C:\programdata\ELPRO\websites\elproUSER\WebClient\config.json

    • Under "suffix", enter the suffix for the elproUSER API using the schema “/User-API”.

    • If the standard port 80 is not used, enter the port of the elproMONITOR additionally under “port”.
      e.g. „port“: 80,"suffix":/user-api

    • Save the changes.

     6.3.3.2. Configure IIS

    • Start IIS Manager (inetmgr.exe).

    • Double-click to expand the <System Servername> of the Connections list.

    Info

    If a pop-up window with a query appears at this point, close the window by clicking No.

    • Expand Sites by double-clicking.

    • Right-click on elproMONITOR → Add Application …

    • Under Alias:, enter a name for the API and under Physical path:, enter the path to the web application directory.
      e.g. Site name: elproUSER, Physical path: C:\programdata\ELPRO\websites\elproUSER\WebClient

    • Exit the configuration and create the new alias by clicking OK.

    Anchor
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    6.4 Creating and Configuring Dedicated Windows User

    Info

    Creating a dedicated Windows user is optional and can be used if the execution of elproEVENT and elproUSER applications is configured as non-administrator.

    Info

    In a multi-tenant system, a tenant can be protected against accesses by other tenants by setting exclusive rights.

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    6.5 Configurations Using the elproMONITOR Management Tool

    • The elproMONITOR Management Tool configures database connection settings for ELPRO applications and activates the basic license for elproMONITOR.

    Anchor
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    6.5.1-elproMONITOR-Management-Tool-starten
    6.5.1 Start the elproMONITOR Management Tool

    • Double-click on the elproMONITOR Management Tool <Setupdirectory>\Program Files\elproMONITOR ManagementTool\elproMonitorManagementTool.exe to start.

    • First a browser appears for you to select the configuration directory.
      e.g. C:\ProgramData\ELPRO\License

    Info

    In newer operating systems, the ProgramData folder is hidden as standard and cannot be selected in Explorer and in the Management Tool. For this, go to Folder Options and change "Hidden files, folders and drives" to "Show".

    • Then you access the main dialog.

    6.5.2. Configure Database Connection Settings for elproMONITOR

    • Under Create XML Setting, click elproMONITOR….

    • Enter the service names and database information from the preceding installation steps in the elproMONITOR XML Settings window.

    Server

    <Database server address>

    Database

    elproMONITOR

    Authentication

    Use SQL Server Authentication

    User name

    elproMonitorDBUser

    Password

    elpro

    Info

    Depending on the configuration of the SQL Server, also enter the instance name in the Server field.

    Info

    The version number has to be entered completely and without mistake!

    • Click Test Connection to check whether the configuration you entered works.

    • Close Window

    6.5.3. Configure Database Connection Settings for elproEVENT

    • Under Create XML Setting, click elproEVENT….

    • Enter the service names and database information from the preceding installation steps in the elproEVENTS XML Settings window.

    Server

    <Database server address>

    Database

    elproEVENT

    Authentication

    Use SQL Server Authentication

    User name

    elproEventDBUser

    Password

    elpro

    Info

    Depending on the configuration of the SQL Server, also enter the instance name in the Server field.

    Info

    The version number has to be entered completely and without mistake!

    • Click Test Connection to check whether the configuration you entered works.

    • Close window.

    Anchor
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    6.5.4.-Datenbankverbindungseinstellungen-für-elproUSER-konfigurieren
    6.5.4. Configure Database Connection Settings for elproUSER

    • Under Create XML Setting, click elproUSER….

    • Enter the service names and database information from the preceding installation steps in the elproEVENTS XML Settings window.

    Server

    <Database server address>

    Database

    elproUSER

    Authentication

    Use SQL Server Authentication

    User name

    elproUserDBUser

    Password

    elpro

    Info

    Depending on the configuration of the SQL Server, also enter the instance name in the Server field.

    Info

    The version number has to be entered completely and without mistake!

    • Click Test Connection to check whether the configuration you entered works.

    • Close window.

    6.5.5. Load Activation and License file for elproMONITOR

    • Start the service elproMONITOR

    • Open the Login Page (Website) of elproMONITOR

    • Login with initial credentials (username: admin, password: elpro)

    • You will be prompted to load the Activation file to activate elproMONITOR

    • Install the Activation file

    • You will be forwarded to the License page of elproMONITOR to load a License file

    • Install the License file

    • Create a link to the desktop for the application <Programdirectory>\elproEVENT<Versionnumber>\Application Folder\elproEVENT.exe.

    • Right-click on this link to open the Properties window.

    • In the Shortcut tab, go to the Target: field and add the parameter –tenant <Configurationdirectory>
      e.g. "C:\Program Files\elproEVENT<VersionNumber>\Application Folder elproEVENT.exe" -tenant "C:\ProgramData\ELPRO\License"

    7. Multi-Tenant System Setup

    elproMONITOR is capable of processing several tenants. This means that optionally, several elproMONITOR systems can be installed and operated in parallel on a computer system.

    elproMONITOR systems run fully autonomously and completely separately from systems installed in parallel. Each system may have different program module versions. Programs and databases can each be operated by separate users so that they are protected against attacks.

    Execute the following steps to set up several tenants on a computer system. Note that all name issues referring to a tenant (DB name, DB user, Service name, etc.) must be unique to ensure isolation between individual tenants.

    • A separate database for the elproMONITOR, elproEVENT, and elproUSER applications must be created for each tenant. Accordingly, separate DB logins and DB users must be created.
      >> 5. Creating Databases

    • Configurations must be created in a separate configuration directory for each tenant.
      e.g. C:\ProgramData\ELPRO\Tenant<TenantName>

    • The configuration for each tenant must be made separately using the Management Tool.

    • If different versions of elproEVENT and elproUSER are to be used, the corresponding libraries must also be imported to the Global Assembly Cache.
      >> 6.1. Importing Libraries in Global Assembly Cache

    • Pro Mandant muss je eine Webapplikation in ein eigenes Webapplikationsverzeichnis kopiert werden. Dies gilt auch falls es sich um eine komplett identische Version handelt
      e.g. C:\inetpub\ELPRO\Tenant<TenantName>\elproMONITOR <VersionNumber>\

    Info

    Never make a difference between web application tenant names by simply changing uppercase and lowercase letters.

    8. System Settings

    System settings may be made in the following databases. Usually, settings only need to be made once and are therefore not included in the Settings.

    8.1. Settings elproMONITOR - To Check

    8.1.1. Tabelle "Setting" Section "UserInterface"

    Name

    Defaults

    Description

    AutoLogin

    False

    Checkbox for Autologin function is not visible

    CalibrationColor

    #fadcc5

    Background color for calibration period

    CalibrationColorOpacity

    100

    Opacity of background color for calibration period

    CalibrationTimeoutInHours

    18

    Maximum calibration time

    ChartColors

    #0000ff,#008000,#ff0000,#00c0c0,#ff00ff,#c0c000,#000080,#00ff02,#800000,#ff8000

    Chart color for sensors

    CommentTextRequired

    True

    The user must enter a comment when acknowledging a deviation.

    DateFormat

    dd.MMM.yyyy

    Date Format

    DeactivatedColor

    #e1e1e1

    Background color for sensor alarm deactivated

    DeactivatedColorOpacity

    100

    Opacity of background color for sensor alarm deactivated

    DeleteButtonActive

    False

    Delete function for sensors and digital inputs deactivated

    EcologProBaseMaintenanceUri

     

    URL for ECOLOG-PRO Base Maintenance software (must be specified as absolute path http://<IP address>/Maintenance or as relative path /Maintenance)

    EcologProBaseVersion

    False

    ElectronicSignature

    True

    The user must repeat his password entry for Activate sensors alarm, Deactivate sensor alarm, and Acknowledge deviation

    ElectronicSignatureLoginRequired

    False

    Login Name must be entered along with the password when confirming deviations

    ElproUserUri

     

    URL for elproUSER software (must be specified as absolute path http://<IP address>/ elproUSER or as relative path /elproUSER)

    FirstDayOfWeek

    Sunday

    Sunday is defined as the first day of the week (Sunday or Monday, depending on the country setting of the server

    InstallationDate

    11/15/2016 12:44:44

    Date of installation This date is set automatically when the system is first installed

    LongTermProcessTimeoutMinutes

    20

    Timeout for processes that last too long

    MaxAnalysisSensors

    25

    Maximum number of sensors that are displayed in the chart

    MaxCalibrationSensors

    10

    Maximum number of sensors which can be calibrated simultaneously

    NumberDecimalSeparator

    .

    Delimiter character for floating point numbers

    PollingInterval

    15000

    Refresh interval for MONITOR / DEVIATION page in milliseconds

    ReloadedColor

    #dae6dc

    Background color for sensor values reloaded

    ReloadedColorOpacity

    100

    Opacity of background color for sensor alarm reloaded

    ReportTimeoutMinutes

    20

    Timeout (minutes) to generate a report

    SessionTimeout

    20

    Session timeout (minutes)

    TenantName

     

    Name which is displayed along with the login name to distinguish an instance

    Use24HourTimeFormat

    True

    The 24-hour time format is used (with False, the 12-hour format is used)

    ValueDateTimeSeparator

    ;

    Character between measurement value and date

    MinSnrValue

    0

    Minimum signal to noise ratio value

    MaxSnrValue

    100

    Maximum signal to noise ratio value

    BadSnrValue

    10

    Industrial Standard for bad signal to ratio value

    WeakSnrValue

    25

    Industrial Standard for bad signal to ratio value

    8.1.2. Tabelle "Setting" Section "System”

    Name

    Defaults

    Description

    AlarmInterfaceRetryCount

    3

    Maximum number of communication retries to the Alarm Interface

    AlarmInterfaceTimeoutMs

    2000

    Timeout (milliseconds) for communication to Alarm Interface

    ConnectionFibonacciDelays

    0,1,2,3,5,8,13,24

    Delay Numbers for connection (using Fibonacci numbers)

    ConnectionWaitTime

    3600

    Waiting for connection

    CriticalDeviceErrorCycleCount

    3

    Number of cycles for deviation of critical device errors

    DbTimeoutSeconds

    30

    Database time-out (in seconds)

    DbTimeoutSensorDelete

    60

    Delete the database time-out for sensor (in seconds)

    DbTimeoutWriteNC

    60

    Write database time-out for NC values (in seconds)

    DO-WatchdogTimeOutInSeconds

    60

    Timeout for ECOLOG-PRO Watchdog (seconds)

    ExportPdfFilenameForAllSensors

    %TimestampUTC%;%ScheduleTaskName%

    File name when the automatically generated PDF report contains all selected sensors

    IntervalLengthDeviationTolerance

    10

    Tolerated interval length deviation in seconds

    Language

    en

    The language setting is used for Audit Trail entries, deviation messages, and automatic reports

    LaunchApplicationTimeout

    00:01:00

    Waiting time during program start

    LoggerConnectRetryCount

    3

    Maximum number of connection retries to a logger

    LoggerConnectTimeoutMs

    2000

    Timeout (milliseconds) for logger connection

    LoggerReadRetryCount

    3

    Maximum number of retries to read out data from a logger memory

    LoggerReadTimeoutMs

    5000

    Timeout for reading out data from a logger memory

    LoggerReconnectDelayMs

    5000

    Delay time (milliseconds) until next connection retry to a logger

    MaxDataSafetyClearanceMonths

    24

    Maximum number of months for data safety clearance period

    MaxEcologNetReloadThreads

    30

    Maximum number of threads to reload data for ECOLOG-NET Loggers If more than 30 ECOLOG-NET loggers are used, set the value to 999.

    MaxEcologProReloadThreads

    1

    Maximum number of threads to reload data for ECOLOG-PRO modules

    MaxLoggerReadThreads

    30

    Maximum number of threads to read measured values

    MktActivationEnergyKjMol

    83.14

    Activation energy for MKT calculation

    MustConfirmAlarms

    True

    Alarm must be acknowledged

    MustConfirmWarnings

    True

    Warning must be acknowledged

    NewStartNcTimeRangeDays

    7

    Maximum number of days for recalculation of NC values after server downtime

    NumberAllowedIntervalLengthDeviations

    10

    Number of permitted deviations in internal length

    NumberOfAcknowledgements

    1

    "Four-eyes-principle" number of acknowledgements needed for a deviation

    PerformaceLogHistoryLengthDays

    7

    Number of days after which data is deleted from the PerformanceLog table.

    RawValueBackupTimeRangeMonths

    24

    Number of months after which data is deleted from the MeasureRawValueBackup table.

    ReloadDelayMs

    1000

    Delay time (milliseconds) before reload starts

    SkippedCycleAlarms

    False

    TimestampUTCFormat

    yyyyMMddHHmmssfff

    Time stamp format

    UseIpV6

    False

    The Internet Protocol Version 4 is used by default. IPV6 is not currently supported

    WcfBaseAddress

    net.pipe://localhost

    The address specifies where the Service Listener is located

    8.1.2. Tabelle "Setting" Section "Plugin”

    Name

    Defaults

    Description

    OrganisationsId

    0

    Uniqe Id (number) of the tenant organisationId (autogenerated, do not change)

    AutomaticIoModuleCreation

    False

    Adding Io modules automatically after pairing

    AutomaticSensorCreation

    False

    Adding a sensor automatically after pairing

    AutomaticSensorCreationGroupName

    Auto-generated

    Group name for the automatically created sensors

    AutomaticSensorCreationIntervalMinutes

    10

    Interval in minutes for automatically created sensors

    RabbitMQPortAMQP

    5672

    AMQP port

    RabbitMQPortMQTT

    1883

    MQTT port

    RabbitMQUsername

    guest

    Chosen user name for RabbitMQ

    RabbitMQPassword

    guest

    Chosen password for RabbitMQ

    SlidingWindowLength

    2

    Sliding window length (valid values from 2 to 5)

    8. System Settings

    System settings may be made in the following databases. Usually, settings only need to be made once and are therefore not included in the Settings.

    8.1. Settings elproMONITOR

    8.1.1. Table "Setting" Section "UserInterface"

    Name

    Defaults

    Description

    AutoLogin

    False

    Checkbox for Autologin function is not visible

    CalibrationColor

    #fadcc5

    Background color for calibration period

    CalibrationColorOpacity

    100

    Opacity of background color for calibration period

    CalibrationTimeoutInHours

    18

    Maximum calibration time

    ChartColors

    #0000ff,#008000,#ff0000,#00c0c0,#ff00ff,#c0c000,#000080,#00ff02,#800000,#ff8000

    Chart color for sensors

    CommentTextRequired

    True

    The user must enter a comment when acknowledging a deviation

    DateFormat

    dd.MMM.yyyy

    Date Format

    DeactivatedColor

    #e1e1e1

    Background color for sensor alarm deactivated

    DeactivatedColorOpacity

    100

    Opacity of background color for sensor alarm deactivated

    DeleteButtonActive

    False

    Delete function for sensors and digital inputs is activated

    EcologProBaseMaintenanceUri

     

    URL for ECOLOG-PRO Base Maintenance software (must be specified as absolute path http://<IP address>/Maintenance or as relative path /Maintenance)

    EcologProBaseVersion

    False

    ElectronicSignature

    True

    The user must repeat his password entry for Activate sensors alarm, Deactivate sensor alarm, and Acknowledge deviation

    ElectronicSignatureLoginRequired

    False

    Login Name must be entered along with the password when confirming deviations

    ElproUserUri

     

    URL for elproUSER software (must be specified as absolute path http://<Host name application server>/ elproUSER)
    -->fully qualified domain name


    In order to use https modify fqdn with https

    FirstDayOfWeek

    Sunday

    Sunday is defined as the first day of the week (Sunday or Monday, depending on the country setting of the server

    InstallationDate

    11/15/2016 12:44:44

    Date of installation This date is set automatically when the system is first installed

    LongTermProcessTimeoutMinutes

    20

    Timeout for processes that last too long

    MaxAnalysisSensors

    25

    Maximum number of sensors that are displayed in the chart

    MaxCalibrationSensors

    10

    Maximum number of sensors which can be calibrated simultaneously

    NumberDecimalSeparator

    .

    Delimiter character for floating point numbers

    PollingInterval

    15000

    Refresh interval for MONITOR / DEVIATION page in milliseconds

    ReloadedColor

    #dae6dc

    Background color for sensor values reloaded

    ReloadedColorOpacity

    100

    Opacity of background color for sensor alarm reloaded

    ReportTimeoutMinutes

    20

    Timeout (minutes) to generate a report

    SessionTimeout

    20

    Session timeout (minutes)

    TenantName

     

    Name which is displayed along with the login name to distinguish an instance

    Use24HourTimeFormat

    True

    The 24-hour time format is used (with False, the 12-hour format is used)

    ValueDateTimeSeparator

    ;

    Character between measurement value and date

    MinSnrValue

    0

    Minimum signal to noise ratio value

    MaxSnrValue

    100

    Maximum signal to noise ratio value

    BadSnrValue

    10

    Industrial Standard for bad signal to ratio value

    WeakSnrValue

    25

    Industrial Standard for bad signal to ratio value

    8.1.2. Table "Setting" Section "System”

    Name

    Defaults

    Description

    AlarmInterfaceRetryCount

    3

    Maximum number of communication retries to the Alarm Interface

    AlarmInterfaceTimeoutMs

    2000

    Timeout (milliseconds) for communication to Alarm Interface

    CalibrationProcessRawValueAmount

    1000

    Number of raw calibration values to be processed at a time

    ConnectionFibonacciDelays

    0

    Delay Numbers for connection (using Fibonacci numbers)

    CriticalDeviceErrorCycleCount

    3

    Number of cycles for deviation of critical device errors

    DbTimeoutSeconds

    30

    Database time-out (in seconds)

    DO-WatchdogTimeOutInSeconds

    60

    Timeout for ECOLOG-PRO Watchdog (seconds)

    EcologNetNoConnectionTimeRangeDays

    14

    Specifies how many days of data to retrieve from EcologNET devices

    EnableHardDeletionOfSensors

    False

    Determines if the hard deletion of sensors feautre is enabled or not

    ExportPdfFilenameForAllSensors

    %TimestampUTC%;%ScheduleTaskName%

    File name when the automatically generated PDF report contains all selected sensors

    Language

    en

    The language setting is used for Audit Trail entries, deviation messages, and automatic reports

    LaunchApplicationTimeout

    00:01:00

    Waiting time during program start

    LoggerConnectRetryCount

    3

    Maximum number of connection retries to a logger

    LoggerConnectTimeoutMs

    2000

    Timeout (milliseconds) for logger connection

    LoggerReadRetryCount

    3

    Maximum number of retries to read out data from a logger memory

    LoggerReadTimeoutMs

    2000

    Timeout for reading out data from a logger memory

    LoggerReconnectDelayMs

    2000

    Delay time (milliseconds) until next connection retry to a logger

    MaxDataSafetyClearanceMonths

    24

    Maximum number of months for data safety clearance period

    MktActivationEnergyKjMol

    83.14

    Activation energy for MKT calculation

    MustConfirmAlarms

    True

    Alarm must be acknowledged

    MustConfirmWarnings

    True

    Warning must be acknowledged

    NoConnectionValueFillerIntervalInDays

    365

    Specifies from how many days ago the system should fill in the missing data with No Connection data

    NoConnectionValueFillerNumberOfIterations

    12

    Specifies how many iterations should do the system in one cycle while filling in the missing data with No Connection data

    NoConnectionValueFillerTimeRangeInHours

    1

    Specifies how many hours should the system process in one iteration while filling in the missing data with No Connection data

    NumberOfAcknowledgements

    1

    "Four-eyes-principle" number of acknowledgements needed for a deviation

    PerformaceLogHistoryLengthDays

    7

    Number of days after which data is deleted from the PerformanceLog table.

    ReloadDelayMs

    1000

    Delay time (milliseconds) before reload starts

    ReloadingOldestMeasureRawValuesInDays

    365

    Specifies how old data should be considered “too old” and not to be reloaded into the system

    SystemName

    Specifies the name of the system - user fills it in

    TimestampUTCFormat

    yyyyMMddHHmmssfff

    Time stamp format

    UseIpV6

    False

    The Internet Protocol Version 4 is used by default. IPV6 is not currently supported

    UseOnlyBasicCharactersInReports

    False

    Only basic characters are permitted in report file names

    ValuesToBeDeletedPerMinute

    1000

    Number of values to be deleted from the database in one cycle if “hard deletion” of the sensors and digital inputs are allowed

    WcfBaseAddress

    net.pipe://localhost

    The address specifies where the Service Listener is located

    8.1.2. Table "Setting" Section "Plugin”

    Name

    Defaults

    Description

    AutomaticIoModuleCreation

    False

    Adding Io modules automatically after pairing

    AutomaticSensorCreation

    False

    Adding a sensor automatically after pairing

    AutomaticSensorCreationGroupName

    Auto-generated

    Group name for the automatically created sensors

    AutomaticSensorCreationIntervalMinutes

    10

    Interval in minutes for automatically created sensors

    EcologNetDataArrivalWaitingTimeSeconds

    90

    Specifies how many seconds are waited before considering the measured value missing for EcologNET devices

    EcologNetMaximumParallelReloadingProcesses

    50

    Specifies how many parallel threads can reload EcologNET devices at the same time

    EcologProDataArrivalWaitingTimeSeconds

    90

    Specifies how many seconds are waited before considering the measured value missing for EcologPro devices

    EcologProPushDataArrivalWaitingTimeSeconds

    210

    Specifies how many seconds are waited before considering the measured value missing for EcologPro Radio devices

    OrganisationsId

    Uniqe Id (number) of the tenant organisationId (autogenerated, do not change)

    ParticleCounterDataArrivalWaitingTimeSeconds

    120

    Specifies how many seconds are waited before considering the measured value missing for Particle Counter devices

    RabbitMqClientCertificatePassphrase

    RabbitMQ Client Certificate passphrase

    RabbitMqClientCertificatePath

    RabbitMQ Client Certificate path

    RabbitMQHostname

    localhost

    Name of the RabbbitMQ host

    RabbitMQIgnoredSslPolicyErrors

    Set of TLS policy (peer verification) errors that are deemed acceptable

    RabbitMQMeasurementConsumerCount

    5

    Number of consumers to consume measurement values

    RabbitMQMeasurementConsumerDispatchConcurrency

    50

    Values greater than 1 enable concurrent processing. These higher values will be offloaded to the worker thread pool so it is important to choose the value for the concurrency wisely to avoid thread pool overloading

    RabbitMQPassword

    guest

    Chosen password for RabbitMQ

    RabbitMQPortAMQP

    5672

    AMQP port

    RabbitMQPortMQTT

    1883

    MQTT port

    RabbitMQUsername

    guest

    Chosen user name for RabbitMQ

    RabbitMQUseTLS

    False

    Specifies whether the usage of TLS is allowed for RabbitMQ or not

    RabbitMQVirtualHost

    /

    Name of RabbitMQ virtual host

    SaveRawValueBatchSize

    5000

    Nmber of raw EcologPro Radio values to be processed and persisted at a time from raw value cache

    SaveRawValueCronJobIntervalSec

    2

    Execution interval for the cronjob which processes and persists the EcologPro Radio values from the raw value cache

    8.1.3. Table "Setting" Section "MailKeepAlive”

    Name

    Defaults

    Description

    Enabled

    False

    Determines if the keep alive service enabled or not

    KeepAliveInterval

    90.00:00:00

    Time interval between sending messages (days)

    MessageSendTime

    12:00:00

    The time of day when the message should be sent

    RecipientId

    Id of entry in the database table Recipient

    8.1.4. Table "Setting" Section "MailSendQueue”

    Name

    Defaults

    Description

    Enabled

    True

    Determines if mail send queue is enabled or not

    MaxQueueTimeHours

    24

    Maximum time in hours messages spend in a queue

    RepeatIntervalMinutes

    10

    Repetition period of messaging attempts in minutes

    8.1.5. Table "Setting" Section "MailServer”

    Name

    Defaults

    Description

    AuthenticationMethod

    Smtp

    Specifies the authentication method. The mails can be sent using Microsoft’s Graph Api (setting: “Azure”) or using an Smtp server (setting: “Smtp”)

    AzureClientId

    Client Id for Microsoft Graph Api authentication

    AzureClientSecret

    Client secret for Microsoft Graph Api authenticaion

    AzureClientSecretId

    Client secret id for Microsoft Graph Api authenticaion

    AzureTenant

    Azure Tenant’s id for Microsoft Graph Api authenticaion

    GraphApiAuthorityUrl

    https://login.microsoftonline.com/

    Graph Api authority url

    GraphApiBaseUrl

    https://graph.microsoft.com/v1.0/

    Graph Api base url

    GraphApiScope

    https://graph.microsoft.com/.default

    Graph Api scope string

    Password

    Password for Smtp server

    SenderAddress

    Sender’s address

    SenderName

    Sender’s name

    ServerAddress

    Smtp server’s address

    ServerPort

    25

    Smtp server’s port

    ServerRequiresAuthentication

    False

    Specifies whether the Smtp Server requires authentication or not

    ServerRequiresSecureConnection

    False

    Specifies whether the Smtp Server requires secure connection or not

    UserName

    User’s name for Smtp server

    8.1.6. Table "Setting" Section "SmsKeepAlive”

    Name

    Defaults

    Description

    Enabled

    False

    Determines if the SMS keepalive service is enabled or not

    KeepAliveInterval

    90

    Time interval between sending messages (days)

    MessageSendTime

    12:00:00

    The time of day when the message should be sent

    RecipientId

    Id of entry in the database table Recipient

    8.1.7. Table "Setting" Section "SmsModem”

    Name

    Defaults

    Description

    BaudRate

    0

    Baud rate set to communicate with the SMS modem. The default value is 57600.

    ComPort

    0

    COM port set to communicate with the SMS modem.

    IpAddress

    SMS modem IP Address

    ModemType

    None

    SMS modem Type

    Port

    0

    SMS modem port

    SimCardPin

    Access code of the SIM card (PIN or PUK).

    8.1.8. Table "Setting" Section "SmsSendQueue”

    Name

    Defaults

    Description

    Enabled

    True

    Determines if the SMS send queue is enabled or not.

    MaxQueueTimeHours

    24

    Specifies the maximum hours a message spends in the queue.

    RepeatIntervalMinutes

    10

    Repetition period of messaging attempts in minutes

    8.1.9. Table "Setting" Section "SystemAlert”

    Name

    Defaults

    Description

    RecipientId

    Recipient profile id for the System Issues

    8.1.10. Table "Setting" Section "Telemetry”

    Name

    Defaults

    Description

    DetailedPerformanceTelemetryChunkCount

    4

    Specifies the number of parts (chunks) in which the telemetry statistics are created

    DetailedPerformanceTelemetryLengthDays

    28

    Specifies the number of past days for which telemetry statistics will be generated.

    LengthOfInspectedAlarmCountsInDays

    30

    Number of days for which the alarms will be grouped in the telemetry report

    LengthOfInspectedReloadingTimeRangeInDays

    14

    Number of days for which the telemetry inspects reloaded data

    8.2. Settings elproEVENT

     8.2.1. "Setting" Table

    Name

    Defaults

    Description

    DateFormat

    dd.MMM.yyyy

    Date format

    TenantName

     

    Name which can be displayed together with application names to distinguish an instance.

    Use24HourFormat

    True

    24 or 12 hour time format

    Language

    en

    The language setting is used for EVENT and Details entries.

    UseIpV6

    False

    If true, IP V6 should be made for Event entries, if IP V6 is available. Otherwise, IP V4.

    8.3. Settings elproUSER

     8.3.1. "AppSettings" Table 

    Name

    Defaults

    Description

    AccessTokenExpireTimeSpanInMinutes

    5

    Timeout (minutes) between Client and Web Server

    ActiveDirectoryEnabled

    True

    Active directory is enabled

    ClientSessionTimeoutInMinutes

    20

    Must be identical to session timeout.

    DateFormat

    dd.MMM.yyyy

    Date Format

    EcologProBaseMaintenanceUri

     

    URL for ECOLOG-PRO Base Maintenance software (must be specified as absolute path http://

    <IP address>/Maintenance or as relative path / Maintenance)

    EcologProBaseVersion

    True

    Tab ECOLOG-PRO Base.

    ElproMonitorUri

     

    URL for elproMONITOR software (must be specified as absolute path http://<IP address>/ elproMONITOR or as relative path /elproMONITOR)

    In order to use http only use the relative path /elproMONITOR.

    In order to use https the absolute path is needed.
    -->fully qualified domain name
    https://<Host name application server>

    Language

    en

    The language setting is used for Audit Trail entries, deviation messages, and automatic reports

    RefreshTokenExpireTimeSpanInMinutes

    43800

     

    SessionTimeout

    20

    Session timeout of server

    TenantName

     

    Name which is displayed together with the login name to distinguish an instance.

    TimeZoneString

    UTC;true

    Time zone; daylight saving time

    Use24HourFormat

    True

    24-hour time format is used (if false, 12-hour format is used)

    UseIPv6

    False

    Internet Protocol version 4 is used by default, currently IPV6 is not supported.

    WcfBaseAddress

    net.tcp://localhost

    The address specifies where the service listener is located.

    9. Operation

     9.1. Start

    • Ensure that the Monitor Service is running and the web application was started in IIS. The applications can be started from the Windows Administrator account.

    • To check this, start Internet Explorer and enter the address http://localhost. The elproMONITOR login page appears. Login using the user previously created in elproUSER (for example, admin).

    Info
    •  After service start when the web application is started for the first time, it may take more than a minute for the login dialog to appear in the browser.

    • When you start the Monitor Service for the first time, the elproMONITOR default settings are written to the database. You can change the settings in the dbo.Settings table of the elproMONITOR database. Please refer to the Operator's Manual for more details.

    9.1.1. Enter elproUSER URL in elproMONITOR Database

    Info

    Requirement: elproMONITOR Service is started!

    • Start SQL Server Management Studio and log in to the database as DB Administrator.
      e.g. /elproUSER

    • In the elproMONITOR database, open the table dbo.Setting for Editing and in ElproUserUri , enter the web client alias from >> 6.3.3 elproUSER Client einrichten (IIS).

    • After the changes in the table dbo.Setting, the following actions are necessary:

      • Restart of elproMONITOR Service

      • Restart of IIS

    9.1.2. Set RabbitMQ credentials in the elproMONITOR Database

    Info

    Requirement: elproMONITOR Service is started!

    • Start SQL Server Management Studio and log in to the database as DB Administrator.
      e.g. /elproUSER

    • In the ElproMONITOR Settings table set the RabbitMQUsername and RabbitMQPassword according to the credentials which was defined in 4.6

    • After the changes in the table dbo.Setting, the following actions are necessary:

      • Restart of elproMONITOR Service

      • Restart of IIS

    9.2. First Start-up of elproUSER

    • Start elproUSER using the link you just created.

    • Login to elproUSER for the first time using the following data:

      • Username: admin

      • Password: elpro

    • You can then change the password immediately after.

    • If you require integration in AD, click Application Options to open the Application Settings window and open the "Active Directory":

      • Enter the Active Directory server name.

      • Enter the user name and password of an AD user with read-only rights to AD.

      • Click the "..." button and select the required subnode for user and groups. (If in doubt, simply select the root node.)

      • Click OK to save the changed settings.

    10. elproMONITOR Management Tool

    Configuring the basic settings of elproMONITOR is performed using the elproMONITOR Management Tool.

    The elproMONITOR software requires a path to a so-called tenant list. When the management tool is started, specify this path as the start parameter. If you leave out the parameter, a window pops up for you to enter the path.

    If other configurations already exist in this path, they are read out and displayed as defaults.

    elproMONITOR is capable of handling several tenants, so several instances can be configured using a tenant list.

    Info

    This procedure is always identical in elproMONITOR, elproUSER, and elproEVENT.

    10.1. Create XML Setting

    11. Additional Features

    11.1. Creating Windows User

     11.1.3. Windows Server 2019

    • Open the Control Panel.

    • Go to User Accounts and click Change account type.

    • Click Add a user account.

    • Enter name, password, and password hint for the new user. Use the tenant's name by preference.
      User name: Customer01
      Password: MonitorCustomer1
      Reenter password: MonitorCustomer1
      Password hint:   <Passwort Hint>

    12. FDA CFR 21 Part 11 Compliance

     If elproMONITOR is to be operated in compliance with FDA CFR 21 Part 11 Revision April 1, 2013, certain measures must be fulfilled.

    Verweis CFR 21 Part 11

    Original Text

    Action

    Subpart A

    § 11.1 Scope (e)

    (e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection.

    ELPRO is willing to allow audits by customers. The operator is responsible for performing audits as required.

    Subpart B

    §11.10 Controls for closed systems (c)

    (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

    The operator is responsible for ensuring that data is preserved in its IT environment, e.g. through backups, intrusion and malware protection, redundant hardware etc.

    Subpart B

    §11.10 Controls for closed systems (e)

    (e) Use of secure, computer generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

    The operator is responsible that changes to the AuditTrail database by IT personnel are prevented. Resp. that manipulations are recorded on system level.

    e.g. by activating the Change Data Capture function.

    The databases must be set up with the restrictions described in the installation instructions.

    Subpart B

    §11.10 Controls for closed systems (i)

    (i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.

    For maintenance, the operator must train his personnel accordingly.

    Subpart B

    §11.10 Controls for closed systems (j)

    (j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

    Establish standards that holds individuals accountable for misuse of signatures.

    Subpart B

    §11.10 Controls for closed systems (k1)

    (1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.

    The operator is responsible to document the operation of the IT system and to control the documentation.

    Subpart C

    §11.100 General requirements (a)

    (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

    Each account must be set up individually per user. Accounts may not be recycled.

    Subpart C

    §11.100 General requirements (b)

    (b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.

    The operator is responsible for ensuring the identity of each user.

    Subpart C

    §11.100 General requirements (c)

    (c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

    The operator is responsible for ensuring that each user is aware of the importance of electronic signatures. Users must attest to this.

    Subpart C

    §11.100 General requirements (c1)

    (1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC100), 5600 Fishers Lane, Rockville, MD 20857.

    Individuals' hand-signed attestation must be sent in hard copy to the Office of Regional Operations (HFC-100).

    Subpart C

    §11.100 General requirements (c2)

    (2) Persons using electronic signatures shall, upon agency request provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.

    Additional attestations must be provided upon request.

    Subpart C

    §11.200 General requirements (a1i)

    (a)(1)(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.

    In the Settings table the setting ElectronicSignature = True must be set.

    Subpart C

    §11.200 General requirements (a1ii)

    (a)(1)(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.

    In the Settings table the setting Autologin = False must be set.

    Subpart C

    §11.200 General requirements (a2)

    (a)(2) Electronic signatures that are not based upon biometrics shall be used only by their genuine owners.

    Only the authenticated owner may use his identification.

    Subpart C

    §11.300 Controls for identification codes/passwords (b)

    (b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging).

    The operator must set the rules of password assignment that they must be renewed regularly.

    13. EudraLex Volume 4 - Annex 11 Compliance

    If elproMONITOR is to be used in compliance with EudraLex Volume 4 - Annex 11 Revision 1, 30 June 2011, certain measures must be fulfilled.

    Verweis Annex 11

    Original Text

    Action

    Principle

    The application should be validated; IT infrastructure should be qualified.

    The operator is responsible for validating his system.

    Principle

    Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.

    The operator must carry out a risk assessment on the entire system. The risk assessment must also include processes and SOPs.

    General

    Risk Management 1

    1. Risk management should be applied throughout the lifecycle of the computerised system taking into account patient safety, data integrity and product quality. As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system.

    The operator is responsible for conducting a risk analysis on the entire system.

    General Personell 2

    1. There should be close cooperation between all relevant personnel such as Process Owner, System Owner, Qualified Persons and IT. All personnel should have appropriate qualifications, level of access and defined responsibilities to carry out their assigned duties.

    The operator is responsible for training users.

    General

    Suppliers and Service Providers 3.4

    3.4 Quality system and audit information relating to suppliers or developers of software and implemented systems should be made available to inspectors on request.

    ELPRO is willing to approve audits conducted by customers. The operator is responsible for conducting audits as required.

    General

    Project Phase 4.4

    4.4 User Requirements Specifications should describe the required functions of the computerised system and be based on documented risk assessment and GMP impact. User requirements should be traceable throughout the lifecycle.

    The operator must describe the system requirements.

    General

    Project Phase 4.5

    4.5 The regulated user should take all reasonable steps, to ensure that the system has been developed in accordance with an appropriate quality management system. The supplier should be assessed appropriately.

    The operator must validate that a suitable quality system was used for development. ELPRO is willing to approve audits conducted by customers.

    General

    Data Storage 7.1

    7.1 Data should be secured by both physical and electronic means against damage. Stored data should be checked for accessibility, readability and accuracy. Access to data should be ensured throughout the retention period.

    The operator is responsible for ensuring data storage in his IT environment, e.g. by means of backups, intrusion and malware protection, redundant hardware, etc.

    General

    Data Storage 7.2

    7.2 Regular back-ups of all relevant data should be done. Integrity and accuracy of backup data and the ability to restore the data should be checked during validation and monitored periodically.

    The operator is responsible for backing up data at regular intervals. The possibility of data restoration must be validated and monitored at regular intervals.

    General

    Change and Configuration Management 10

    10. Any changes to a computerised system including system configurations should only be made in a controlled manner in accordance with a defined procedure.

    The operator is responsible for carrying out changes according to a defined process.

    General

    Periodic evaluation 11

    11. Computerised systems should be periodically evaluated to confirm that they remain in a valid state and are compliant with GMP. Such evaluations should include, where appropriate, the current range of functionality, deviation records, incidents, problems, upgrade history, performance, reliability, security and validation status reports.

    The operator is responsible for validating the system periodically.

    General Security 12.1

    12.1 Physical and/or logical controls should be in place to restrict access to computerized system to authorised persons. Suitable methods of preventing unauthorised entry to the system may include the use of keys, pass cards, personal codes with passwords, biometrics, restricted access to computer equipment and data storage areas.

    The operator must guarantee that no unauthorized persons may gain access to the system.

    General Security 12.2

    12.2 The extent of security controls depends on the criticality of the computerised system.

    The operator must carry out risk analyses for relevance.

    General

    Incident Management 13

    13. All incidents, not only system failures and data errors, should be reported and assessed. The root cause of a critical incident should be identified and should form the basis of corrective and preventive actions.

    The operator must evaluate audit trails and, if necessary, escalate events by forwarding them to ELPRO.

    General

    Electronic Signature 14

    14. Electronic records may be signed electronically. Electronic signatures are expected to:

    a.  have the same impact as hand-written signatures within the boundaries of the company,

    b.  be permanently linked to their respective record,

    c.  include the time and date that they were applied.

    The setting ElectronicSignature = True must be set in the Settings table. Signature recognition must be regulated internally.

    General

    Batch release 15

    15. When a computerised system is used for recording certification and batch release, the system should allow only Qualified Persons to certify the release of the batches and it should clearly identify and record the person releasing or certifying the batches. This should be performed using an electronic signature.

    The operator must ensure that only identified persons may release batches.

    General

    Business Continuity 16

    16. For the availability of computerised systems supporting critical processes, provisions should be made to ensure continuity of support for those processes in the event of a system breakdown (e.g. a manual or alternative system). The time required to bring the alternative arrangements into use should be based on risk and appropriate for a particular system and the business process it supports. These arrangements should be adequately documented and tested.

    The operator must make sure that business continuity is ensured in case of system failure.


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