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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
titleLimited warranty and limitations of liability

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
titleTable of Contents
Table of Contents

1. 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!

Note

SQL Server compatibility level 130 and above is required

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.

elproMonitor_<version>.zip/elproMONITOR

elproMONITOR SQL Script

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

elproMonitor_<version>.zip/support-tools/database/MonitorSchema.sql

Management Tool

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

elproMonitor_<version>.zip/support-tools/shared/elproMONITOR Management Tool

MSVC Redistributables

Redistributables which are needed to execute elproMONITOR.

elproMonitor_<version>.zip/prerequisites/MCVC Redistributables

elproEVENT Application

The elproEVENT application.

elproEvent_<version>.zip/elproEvent

elproEVENT SQL Script

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

elproEvent_<version>.zip/elproEvent/Setup Files/SQLScripts/CreateEventSchema.sql

elproUSER Service

Service that uses rights and user management.

elproUser_<version>.zip/Program Files/elproUSER<Versionsnumber>/UserService

elproUSER SQL Script

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

elproUser_<version>.zip/Setup Files/SQLScripts/CreateUserSchema.sql

RabbitMQ Service

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

elproMonitor_<version>.zip/prerequisites/RabbitMQ <version>
See >> 4.6. RabbitMQ Installation

ProModuleConfigurator

Configuration tool for editing the ECOLOGPRO modules

elproMonitor_<version>.zip/support-tools/shared/ProModuleConfigurator

RBRConfigurator

Config-Tool zum bearbeiten der ECOLOG-PRO RBR Modules

elproMonitor_<version>.zip/support-tools/shared/EcologPRO Radio configurator

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

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No

Protocol

Port

Description

1

TCP

502

Configuring and pulling measurements and status information from ecologPro devices

2

TCP

1883

Pushing measurements and status information to RabbitMQ broker

UDP

1883

RBR time synchronization service

3

TCP

502

Configuring and pulling measurements and status information from Apex Particle Counter devices

4

TCP

2101

Configuring and pulling measurements and status information from ecologNET devices

5

TCP

Default: 10001

elproMONITOR configuration
Sending SMS notifications

6

TCP

1433

Application SQL database connection

7

TCP

80/443/81

Client access to elproMONITOR, elproUSER and webAccess applications

8

TCP

443

Sending e-mail notifications via Office 365’s Graph Api

9

TCP

587

Sending e-mail notifications via a configured SMTP server

10

TCP

22123

Initial configuration for RBR devices

11

UDP

30718

Initial configuration for LBR devices

4.1.2.4. Firewall Rules

Application Server

Note

Dedicated webserver is not supported therefore Port 8000 should be closed as opposed to previous versions

Requires tcp port 443 to be open (https), optionally port 80 (http) and 81 (WebAccess).

Requires tcp port 1883 (MQTT) for RBR devices to be able to push messages to RabbitQq, this port is configurable in RabbitMQ configuration and ElproMonitor database.

Requires udp port 1883 for RBR devices to synchronize time with the Application server. This port follows the previous one, just uses udp protocol.

Optionally tcp port 15672 could be opened to give access to RabbieMQ’s web management interface.

EcologPro LBR

EcologPro LBR devices are accessed through the default modbus tcp port 502.

EcologPro RBR

EcologPro RBR devices are initially configured with the Radio Configurator tool via tcp port 22123.

Apex Particle Counter

Apex Particle Counters are accessed through the default modbus tcp port 502.

EcologNet

EcologNet devices are accessed through tcp port 2101.

SMS modem

The tcp connection parameters for the SMS modem are configured inside ElproMonitor’s Settings/SMS page.

SQL Database

For the SQL database connection the default tcp port 1433 is used, it is configured inside a connection string under ElproMONITOR’s install folder, appsettings.json file.

ElproMonitor Management Tool’s Test Connection function also uses tcp port 1433 to check the connection via the provided configuration.

Graph Api

ElproMonitor (Application server) needs access to the world wide web in case e-mail notifications are configured to use Microsoft’s Office 365 Graph Api under Settings/E-Mail page.

SMTP server

When SMTP E-mail notification is configured in ElproMonitor Settings/E-Mail page, ElproMonitor needs access to the SMTP server configured on the page.

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

  • Install additional IIS modules

Info

NET Framework 8.0 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\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 files 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. Install RabbitMQ

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

Enable the RabbitMQ Management web interface and MQTT

Code Block
breakoutModewide
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.13.3\sbin\rabbitmq-plugins.bat" enable rabbitmq_management
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.13.3\sbin\rabbitmq-plugins.bat" enable rabbitmq_mqtt
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.13.3\sbin\rabbitmq-service.bat" stop
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.13.3\sbin\rabbitmq-service.bat" start

4.6.3. Apply the advanced configurations

  • Stop the service

Code Block
breakoutModewide
"c:\Program Files\RabbitMQ Server\rabbitmq_server-3.13.3\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-3.13.3\sbin\rabbitmq-service.bat" start

4.6.4. 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

  • RabbitMQUsername <username for elproMONITOR connection>

  • RabbitMQPassword <password for elproMONITOR connection>

4.6.5. Create the RabbitMQ users for elproMONITOR and the MQTT Plugin

Use the following snippet to create new users in RabbitMQ with the right permissions for the default vhost '/'

Code Block
rabbitmqctl.bat add_user "username" "password"
rabbitmqctl.bat set_permissions -p / "mqtt-anonymous-user" ".*" ".*" ".*"
  • Create the elproMONITOR user defined in 4.6.5

  • Create the MQTT user defined in the rabbitmq.conf file in 4.6.4

4.6.6. Nice to know: Configure RabbitMQ manually

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

Code Block
rabbitmqctl.bat add_user "mqtt-anonymous-user" "Password1234"
rabbitmqctl.bat set_permissions -p / "mqtt-anonymous-user" ".*" ".*" ".*"
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: ex.elproMONITOR
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: ex.elproMONITOR
Routing key: ~uplink.bridge
Arugments: empty
  • Select the uplink.module.others queue and add the following bindings

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

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

4.6.7 Setting up the External Api

  • Create a virtual host dedicated for the External Api

Info

The name of the new virtual host dedicated for the External Api has to match with the ExternalApiVirtualHost setting (defaults to externalapi) in dbo.OrganizationSettings table inside elproMONITOR’s database

  • Create the new user for the above created virtual host (change credentials if needed)

Code Block
rabbitmqctl.bat add_user "external-api-user" "Password1234"
rabbitmqctl.bat set_permissions -p externalapi "external-api-user" ".*" ".*" ".*"
Note

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

Code Block
Virtual host: externalapi
Name: ex.elproMONITOR
Type: topic
Durability: durable
Auto-delete: false
Internal: false
Arguments: empty
Info

In order for the External Api to send messages, additionally the ExternalApiEnableV1 setting has to be set to True in dbo.OrganizationSettings table inside elproMONITOR’s database

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 elproMonitor_<version>.zip/support-tools/database/MonitorSchema.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.

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 MonitorSchema.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 MonitorSchema.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 MonitorSchema.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.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. elproUSER)

  • Close the Template Parameters window by clicking OK.

  • Click Execute (F5) to execute the script.

6. Installation and Configuration

  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.

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6.1.-Setup-Windows-Event-Display-for-elproEVENT
6.1.-Setup-Windows-Event-Display-for-elproEVENT
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"

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6.2. Setting up the elproMONITOR Web Application

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6.2.1.-elproMONITOR-Service-einrichten
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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

  • Open the start menu, and start typing regedit and start the Registry Editor (regedit.exe)

  • Navigate to HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\Services\elproMONITOR (this should match with the name of the service installed before)

  • Inside the main area right click and choose New → Multi-String Value, name it Environment

  • Double click the created key and write ASPNETCORE_ENVIRONMENT=Production inside the Value data area

  • Press Ok, an error message-like window might appear, ignore it

  • By default elproMONITOR service is listening on http://localhost:5000/ both on IPv4 127.0.0.1:5000 and IPv6 [::1]:5000 if it manages to find corresponding loopback interfaces

    • Generally we should prefer IPv4 to simplify the routing configuration, also we might desire that elproMonitor only listens on a specific interface and address, in this case refer to

      Run elproMONITOR service on a different port

    • You can check binded ports using “netstat -ona” in powershell, you should see elproMonitor listening on the defined port

  • You can test whether elproMonitor is working by navigation to this url with a browser on localhost, the application should load and appear

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6.2.1.1. Run elproMONITOR service on a different port

  • Navigate to elproMONITOR install folder (usually C:\Program Files\elproMONITOR), and open the appsettings.Production.json for editing

    • Note that there are multiple appsettings file, the application merges the plain appsettings.json file with the one setup in ASPNETCORE_ENVIRONMENT environment variable, e. g. ASPNETCORE_ENVIRONMENT=Production => appsettings.json and appsettings.Production.json is merged to provide the configuration

  • Add the following line to the top of the appsettings.Production.json file: "Urls": "http://127.0.0.1:12345",

    • Alternatively you can provide the desired ip address, so the service won’t listen on every available interface with assigned IPv4 address on the machine e. g. "Urls": "http://192.168.1.189:12345”,

  • Note that there is a comma behind the added line, and there is no comma after the last line / closing bracket

 

image-20240423-075919.png
  • Restart elproMONITOR service

  • You can check binded ports using “netstat -ona” in powershell, you should see elproMonitor listening on the defined port

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

6.2.2.1. 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.

  • Rename the entry from Default Web Site to elproMONITOR

    • Path: C:\inetpub\wwwroot

  • Right-click Sites → Add Web Site …

  • 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.

6.2.2.2. Configure the reverse proxy

  • Click on the top node (the actual server) inside the server tree area on the left side.

  • In the main area double click Application Request Routing Cache

  • In the right area new Actions should appear, click Server Proxy Settings…

  • Check the Enable proxy checkbox and click Apply on the right side inside the Actions pane

  • Navigate back to the Site created in the previous step

  • Double click the URL Rewrite module

  • Click Add Rule(s)… inside the Actions pane on the right side

  • Selecte Reverse Proxy and hit Ok

  • In the first input field enter the address where elproMONITOR service is listening, configured in a previous step (usually http://localhost:5000/)

  • Make sure Enable SLL Offloading checkbox is checked then hit Ok

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6.3.-Setting-up-the-elproUSER-Web-Application
6.3.-Setting-up-the-elproUSER-Web-Application
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.

  • Navigate to the Site created in a previous step

  • Double click the URL Rewrite module

  • Click Add Rule(s)… inside the Actions pane on the right side

  • Select Blank rule then hit Ok

  • Name the Inbound Rule e.g. user-api

  • Put the following pattern in the Pattern input: ^user-api(.*)

Info

The text inside the pattern has to match the alias of the added application in the previous step

  • Inside the Action group, select None from the Action type dropdown

  • Make sure the Stop processing of subsequent rules checkbox is checked

  • Click Apply then Back to Rules on the right side inside the Actions pane

  • Make sure that the new user-api rule we have just created is at the top of the list in the main area of the window

    • If this is not the case, then select the newly created user-api rule and click Move Up on the right side inside the Actions pane

    • Confirm the action by clicking Yes in the popup window

    • Repeat this step until the user-api rule is at the top of the list

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6.3.3.-elproUSER-Client-einrichten-(IIS)
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.

  • Navigate to the Site created in a previous step

  • Double click the URL Rewrite module

  • Click Add Rule(s)… inside the Actions pane on the right side

  • Select Blank rule then hit Ok

  • Name the Inbound Rule e.g. elproUSER

  • Put the following pattern in the Pattern input: ^elproUSER(.*)

Info

The text inside the pattern has to match the alias of the added application in the previous step

  • Inside the Action group, select None from the Action type dropdown

  • Make sure the Stop processing of subsequent rules checkbox is checked

  • Click Apply then Back to Rules on the right side inside the Actions pane

  • Make sure that the new elproUSER rule we have just created is at the top of the list in the main area of the window

    • If this is not the case, then select the newly created elproUSER rule and click Move Up on the right side inside the Actions pane

    • Confirm the action by clicking Yes in the popup window

    • Repeat this step until the user-api rule is at the top of the list

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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-Konfigurationen-mit-dem-elproMONITOR-Management-Tool
6.5 Configurations Using the elproMONITOR Management Tool

  • The elproMONITOR Management Tool configures database connection settings for ELPRO applications.

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6.5.1-elproMONITOR-Management-Tool-starten
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 elproMONITOR’s install directory.
    e.g. C:\Program Files\elproMONITOR

  • 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.

  • Click Add Tenant Config and browse the folder of the tenant configuration file (usually C:\ProgramData\Elpro), click Ok

  • Click Save to save the configuration

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.

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6.5.4.-Datenbankverbindungseinstellungen-für-elproUSER-konfigurieren
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

Note

Not more supported.

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. Migration from earlier version

Info

In 3.1.0 the original dbo.Setting table has been split up to multiple tables and a configuration file. Everyone migrating from an earlier version should take a note of the original dbo.Setting table.
Automated migration is only done for settings that remained in the database.
Any setting’s value that was manually modified and moved to the configuration file should be migrated MANUALLY based on the previous dbo.Setting table, as the new configuration file only contains default values. Such setting could be e. g. ElproSupportTicketUri, ElproUserUri

The configuration file is located under elproMonitorService’s installation folder (usually under C:\Program Files\elproMONITOR\appsettings.json)

The settings that were migrated into a configuration file from the original dbo.Setting table are listed in the table below.

Old database setting key (was removed from database)

Configuration key (was added to appsettings.json)

Default value

GraphApiAuthorityUrl

GraphApiAuthorityUrl

"https://login.microsoftonline.com/"

GraphApiBaseUrl

GraphApiBaseUrl

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

GraphApiScope

GraphApiScope

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

ElectronicSignatureLoginRequired

ElectronicSignatureLoginRequired

false

ReloadDelayMs

ReloadDelayMs

1000

AutoLogin

AutoLogin

false

SessionTimeout

SessionTimeoutMinutes

20

PollingInterval

PollingIntervalms

15000

MaxAnalysisSensors

MaxAnalysisSensors

25

MaxCalibrationSensors

MaxCalibrationSensors

50

CalibrationTimeoutInHours

CalibrationTimeoutInHours

18

ElectronicSignature

ElectronicSignature

true

ReportTimeoutMinutes

ReportTimeoutMinutes

20

LongTermProcessTimeoutMinutes

LongTermProcessTimeoutMinutes

20

ElproUserUri

ElproUserUri

““

EcologProBaseMaintenanceUri

EcologProBaseMaintenanceUri

““

EcologProBaseVersion

EcologProBaseVersion

false

ElproSupportTicketUri

ElproSupportTicketUri

"https://www.elpro.com/support "

LaunchApplicationTimeout

LaunchApplicationTimeout

"00:01:00"

LoggerConnectTimeoutMs

LoggerConnectTimeoutms

2000

LoggerConnectRetryCount

LoggerConnectRetryCount

3

LoggerReadTimeoutMs

LoggerReadTimeoutms

2000

LoggerReadRetryCount

LoggerReadRetryCount

3

LoggerReconnectDelayMs

LoggerReconnectDelayms

2000

EcologNetNoConnectionTimeRangeDays

EcologNetNoConnectionTimeRangeDays

14

PerformaceLogHistoryLengthDays

PerformaceLogHistoryLengthDays

7

UseIpV6

UseIpV6

false

DbTimeoutSeconds

DbTimeoutSeconds

30

AlarmInterfaceTimeoutMs

DigitalOutputTimeoutms

2000

AlarmInterfaceRetryCount

DigitalOutputRetryCount

3

DOWatchdogTimeOutInSeconds

DOWatchdogTimeOutInSeconds

60

ConnectionFibonacciDelays

ConnectionFibonacciDelays

[ 0 ]

ValuesToBeDeletedPerMinute

ValuesToBeDeletedPerMinute

1000

MeasurementProcessingMvQueryPartitionSize

MeasurementProcessingMvQueryPartitionSize

20000

ReloadingOldestMeasureRawValuesInDays

ReloadingOldestMeasureRawValuesInDays

365

CalibrationProcessRawValueAmount

CalibrationProcessRawValueAmount

1000

NoConnectionValueFillerIntervalInDays

NoConnectionValueFillerIntervalInDays

365

NoConnectionValueFillerTimeRangeInHours

NoConnectionValueFillerTimeRangeInHours

1

NoConnectionValueFillerNumberOfIterations

NoConnectionValueFillerNumberOfIterations

12

SaveRawValueBatchSize

SaveRawValueBatchSize

5000

SaveRawValueCronJobIntervalSec

SaveRawValueCronJobIntervalSec

2

EcologNetDataArrivalWaitingTimeSeconds

EcologNetDataArrivalWaitingTimeSeconds

90

EcologProDataArrivalWaitingTimeSeconds

EcologProDataArrivalWaitingTimeSeconds

90

EcologProPushDataArrivalWaitingTimeSeconds

EcologProPushDataArrivalWaitingTimeSeconds

210

ParticleCounterDataArrivalWaitingTimeSeconds

ParticleCounterDataArrivalWaitingTimeSeconds

120

EcologNetMaximumParallelReloadingProcesses

EcologNetMaximumParallelReloadingProcesses

50

LengthOfInspectedReloadingTimeRangeInDays

LengthOfInspectedReloadingTimeRangeInDays

14

LengthOfInspectedAlarmCountsInDays

LengthOfInspectedAlarmCountsInDays

30

DetailedPerformanceTelemetryLengthDays

DetailedPerformanceTelemetryLengthDays

28

DetailedPerformanceTelemetryChunkCount

DetailedPerformanceTelemetryChunkCount

4

8.1.2. Table "Setting" Section "Email”

Old database setting key

New database settings key

Group name

Default value

 Description

AuthenticationMethod

AuthenticationMethod

Email

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

AzureClientId

Email

<empty>

Client Id for Microsoft Graph Api authentication

AzureClientSecret

AzureClientSecret

Email

<empty>

Client secret for Microsoft Graph Api authenticaion

AzureClientSecretId

AzureClientSecretId

Email

<empty>

Client secret id for Microsoft Graph Api authenticaion

AzureTenant

AzureTenant

Email

<empty>

Azure Tenant’s id for Microsoft Graph Api authenticaion

Enabled

QueueEnabled

Email

True

Determines if mail send queue is enabled or not

Enabled

KeepAliveEnabled

Email

False

Determines if the keep alive service enabled or not

KeepAliveInterval

KeepAliveInterval

Email

90.00:00:00

Time interval between sending messages (days)

MaxQueueTimeHours

QueueMaximumQueueTimeHours

Email

24

Maximum time in hours messages spend in a queue

MessageSendTime

KeepAliveMessageSendTime

Email

12:00:00

The time of day when the message should be sent

Password

Password

Email

<empty>

Password for Smtp server

RecipientId

KeepAliveRecipientId

Email

<empty>

Id of entry in the database table Recipient

RepeatIntervalMinutes

QueueRepeatTimeIntervalMinutes

Email

10

Repetition period of messaging attempts in minutes

SenderAddress

SenderAddress

Email

<empty>

Sender’s address

SenderName

SenderName

Email

<empty>

Sender’s name

ServerAddress

Address

Email

<empty>

Smtp server’s address

ServerPort

Port

Email

25

Smtp server’s port

ServerRequiresAuthentication

RequiresAuthentication

Email

False

Specifies whether the Smtp Server requires authentication or not

ServerRequiresSecureConnection

RequiresSecureConnection

Email

False

Specifies whether the Smtp Server requires secure connection or not

UserName

UserName

Email

<empty>

User’s name for Smtp server

8.1.2. Table "Setting" Section "Sms”

Old database setting key

New database settings key

Group name

Default value

 Description

BaudRate

BaudRate

Sms

0

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

ComPort

ComPort

Sms

0

COM port set to communicate with the SMS modem.

Enabled

QueueEnabled

Sms

True

Determines if mail send queue is enabled or not

Enabled

KeepAliveEnabled

Sms

False

Determines if the keep alive service enabled or not

IpAddress

IpAddress

Sms

<empty>

SMS modem IP Address

KeepAliveInterval

KeepAliveInterval

Sms

90.00:00:00

Time interval between sending messages (days)

MaxQueueTimeHours

QueueMaximumQueueTimeHours

Sms

24

Maximum time in hours messages spend in a queue

MessageSendTime

KeepAliveMessageSendTime

Sms

12:00:00

The time of day when the message should be sent

ModemType

ModemType

Sms

None

SMS modem Type

Port

Port

Sms

0

SMS modem port

RecipientId

KeepAliveRecipientId

Sms

<empty>

Id of entry in the database table Recipient

RepeatIntervalMinutes

QueueRepeatTimeIntervalMinutes

Sms

10

Repetition period of messaging attempts in minutes

SimCardPin

SimCardPin

Sms

<empty>

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

8.1.3. Table "Setting" Section "Application”

Old database setting key

New database settings key

Group name

Default value

Description

InstallationDate

InstallationDate

Application

First installation date

First installation date

OrganisationId

RbrOrganizationId

Application

<empty>

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

RabbitMqClientCertificatePassphrase

RabbitMqClientCertificatePassphrase

Application

<empty>

RabbitMQ Client Certificate passphrase

RabbitMqClientCertificatePath

RabbitMqClientCertificatePath

Application

<empty>

RabbitMQ Client Certificate path

RabbitMQHostname

RabbitMQHostname

Application

localhost

Name of the RabbbitMQ host

RabbitMQIgnoredSslPolicyErrors

RabbitMQIgnoredSslPolicyErrors

Application

None

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

RabbitMQMeasurementConsumerCount

RabbitMQMeasurementConsumerCount

Application

5

Number of consumers to consume measurement values

RabbitMQMeasurementConsumerDispatchConcurrency

RabbitMQMeasurementConsumerDispatchConcurrency

Application

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

RabbitMQPassword

Application

guest

Chosen password for RabbitMQ

RabbitMQPortAMQP

RabbitMQPortAMQP

Application

5672

AMQP port

RabbitMQPortMQTT

RabbitMQPortMQTT

Application

1883

MQTT port

RabbitMQUsername

RabbitMQUsername

Application

guest

Chosen user name for RabbitMQ

RabbitMQUseTLS

RabbitMQUseTLS

Application

False

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

RabbitMQVirtualHost

RabbitMQVirtualHost

Application

/

Name of RabbitMQ virtual host

RecipientId

SystemAlertRecipientId

Application

<empty>

Recipient profile id for the System Issues

SystemName

SystemName

Application

<empty>

Specifies the name of the system - user fills it in

8.1.4. Table "OrganizationSettings" Section "Application”

Old database setting key

New database settings key

Group name

Default value

Description

AutomaticIoModuleCreation

AutomaticIoModuleCreation

Application

True

Adding Io modules automatically after pairing

AutomaticSensorCreation

AutomaticSensorCreation

Application

False

Adding a sensor automatically after pairing

AutomaticSensorCreationGroupName

AutomaticSensorCreationGroupName

Application

Auto-generated

Group name for the automatically created sensors

AutomaticSensorCreationInputState

AutomaticSensorCreationInputState

Application

Deactivated

State of the automatically created sensor

AutomaticSensorCreationIntervalMinutes

AutomaticSensorCreationIntervalMinutes

Application

10

Interval in minutes for automatically created sensors

BadSnrValue

BadSnrValue

Application

10

Industrial Standard for bad signal to ratio value

CalibrationColor

CalibrationColor

Application

#fadcc5

Background color for calibration period

CalibrationColorOpacity

CalibrationColorOpacity

Application

100

Opacity of background color for calibration period

ChartColors

ChartColors

Application

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

Chart color for sensors

CommentTextRequired

CommentTextRequired

Application

True

The user must enter a comment when acknowledging a deviation

CriticalDeviceErrorCycleCount

CriticalDeviceErrorCycleCount

Application

3

Number of cycles for deviation of critical device errors

DateFormat

DateFormat

Application

dd.MMM.yyyy

Date Format

DeactivatedColor

DeactivatedColor

Application

#e1e1e1

Background color for sensor alarm deactivated

DeactivatedColorOpacity

DeactivatedColorOpacity

Application

100

Opacity of background color for sensor alarm deactivated

DeleteButtonActive

DeleteButtonActive

Application

False

Delete function for sensors and digital inputs is activated

EnableHardDeletionOfSensors

EnableHardDeletionOfSensors

Application

False

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

ExportPdfFilenameForAllSensors

ExportPdfFilenameForAllSensors

Application

%TimestampUTC%;%ScheduleTaskName%

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

ExternalApiVirtualHost

ExternalApiVirtualHost

Application

externalapi

Virtual Host for the ExternalApi created in RabbitMq

ExternalApiEnableV1

ExternalApiEnableV1

Application

False

Enable the ExternalApi to send messages

FirstDayOfWeek

FirstDayOfWeek

Application

Server localization dependent

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

Language

Language

Application

en

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

MaxDataSafetyClearanceMonths

MaxDataSafetyClearanceMonths

Application

24

Maximum number of months for data safety clearance period

MaxSnrValue

MaxSnrValue

Application

100

Maximum signal to noise ratio value

MinSnrValue

MinSnrValue

Application

0

Minimum signal to noise ratio value

MktActivationEnergyKjMol

MktActivationEnergyKjMol

Application

83.14

Activation energy for MKT calculation

MustConfirmAlarms

MustConfirmAlarms

Application

True

Alarm must be acknowledged

MustConfirmWarnings

MustConfirmWarnings

Application

True

Warning must be acknowledged

NumberDecimalSeparator

NumberDecimalSeparator

Application

Server localization dependent

Delimiter character for floating point numbers

NumberOfAcknowledgements

NumberOfAcknowledgements

Application

1

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

ReloadedColor

ReloadedColor

Application

#dae6dc

Background color for sensor values reloaded

ReloadedColorOpacity

ReloadedColorOpacity

Application

100

Opacity of background color for sensor alarm reloaded

TenantName

TenantName

Application

<empty>

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

TimestampUTCFormat

TimestampUTCFormat

Application

yyyyMMddHHmmssfff

Time stamp format

Use24HourTimeFormat

Use24HourTimeFormat

Application

True

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

UseOnlyBasicCharactersInReports

UseOnlyBasicCharactersInReports

Application

False

Only basic characters are permitted in report file names

ValueDateTimeSeparator

ValueDateTimeSeparator

Application

;

Character between measurement value and date

WeakSnrValue

WeakSnrValue

Application

25

Industrial Standard for bad signal to ratio value

8.1.5. Configuration file appsettings.json

Old database setting key (was removed from database)

Configuration key (was added to appsettings.json)

Default value

Description

AlarmInterfaceRetryCount

DigitalOutputRetryCount

3

Maximum number of communication retries to the Alarm Interface

AlarmInterfaceTimeoutMs

DigitalOutputTimeoutms

2000

Timeout (milliseconds) for communication to Alarm Interface

AutoLogin

AutoLogin

false

Checkbox for Autologin function is not visible

CalibrationProcessRawValueAmount

CalibrationProcessRawValueAmount

1000

Number of raw calibration values to be processed at a time

CalibrationTimeoutInHours

CalibrationTimeoutInHours

18

Maximum calibration time

ConnectionFibonacciDelays

ConnectionFibonacciDelays

[ 0 ]

Delay Numbers for connection (using Fibonacci numbers)

DbTimeoutSeconds

DbTimeoutSeconds

30

Database time-out (in seconds)

DetailedPerformanceTelemetryChunkCount

DetailedPerformanceTelemetryChunkCount

4

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

DetailedPerformanceTelemetryLengthDays

DetailedPerformanceTelemetryLengthDays

28

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

DOWatchdogTimeOutInSeconds

DOWatchdogTimeOutInSeconds

60

EcologNetDataArrivalWaitingTimeSeconds

EcologNetDataArrivalWaitingTimeSeconds

90

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

EcologNetMaximumParallelReloadingProcesses

EcologNetMaximumParallelReloadingProcesses

50

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

EcologNetNoConnectionTimeRangeDays

EcologNetNoConnectionTimeRangeDays

14

Specifies how many days of data to retrieve from EcologNET devices

EcologProBaseMaintenanceUri

EcologProBaseMaintenanceUri

““

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

EcologProBaseVersion

EcologProBaseVersion

false

EcologProDataArrivalWaitingTimeSeconds

EcologProDataArrivalWaitingTimeSeconds

90

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

EcologProPushDataArrivalWaitingTimeSeconds

EcologProPushDataArrivalWaitingTimeSeconds

210

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

ElectronicSignature

ElectronicSignature

true

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

ElectronicSignatureLoginRequired

ElectronicSignatureLoginRequired

false

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

ElproSupportTicketUri

ElproSupportTicketUri

"https://www.elpro.com/support "

ElproUserUri

ElproUserUri

““

URL for elproUSER software (realitve path)

GraphApiAuthorityUrl

GraphApiAuthorityUrl

"https://login.microsoftonline.com/"

Graph Api authority url

GraphApiBaseUrl

GraphApiBaseUrl

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

Graph Api base url

GraphApiScope

GraphApiScope

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

Graph Api scope string

LaunchApplicationTimeout

LaunchApplicationTimeout

"00:01:00"

Waiting time during program start

LengthOfInspectedAlarmCountsInDays

LengthOfInspectedAlarmCountsInDays

30

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

LengthOfInspectedReloadingTimeRangeInDays

LengthOfInspectedReloadingTimeRangeInDays

14

Number of days for which the telemetry inspects reloaded data

LoggerConnectRetryCount

LoggerConnectRetryCount

3

Maximum number of connection retries to a logger

LoggerConnectTimeoutMs

LoggerConnectTimeoutms

2000

Timeout (milliseconds) for logger connection

LoggerReadRetryCount

LoggerReadRetryCount

3

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

LoggerReadTimeoutMs

LoggerReadTimeoutms

2000

Timeout for reading out data from a logger memory

LoggerReconnectDelayMs

LoggerReconnectDelayms

2000

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

LongTermProcessTimeoutMinutes

LongTermProcessTimeoutMinutes

20

Timeout for processes that last too long

MaxAnalysisSensors

MaxAnalysisSensors

25

Maximum number of sensors that are displayed in the chart

MaxCalibrationSensors

MaxCalibrationSensors

50

Maximum number of sensors which can be calibrated simultaneously

MeasurementProcessingMvQueryPartitionSize

MeasurementProcessingMvQueryPartitionSize

20000

NoConnectionValueFillerIntervalInDays

NoConnectionValueFillerIntervalInDays

365

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

NoConnectionValueFillerNumberOfIterations

NoConnectionValueFillerNumberOfIterations

12

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

NoConnectionValueFillerTimeRangeInHours

NoConnectionValueFillerTimeRangeInHours

1

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

ParticleCounterDataArrivalWaitingTimeSeconds

ParticleCounterDataArrivalWaitingTimeSeconds

120

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

PerformaceLogHistoryLengthDays

PerformaceLogHistoryLengthDays

7

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

PollingInterval

PollingIntervalms

15000

Refresh interval for MONITOR / DEVIATION page in milliseconds

ReloadDelayMs

ReloadDelayMs

1000

Delay time (milliseconds) before reload starts

ReloadingOldestMeasureRawValuesInDays

ReloadingOldestMeasureRawValuesInDays

365

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

ReportTimeoutMinutes

ReportTimeoutMinutes

20

Timeout (minutes) to generate a report

SaveRawValueBatchSize

SaveRawValueBatchSize

5000

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

SaveRawValueCronJobIntervalSec

SaveRawValueCronJobIntervalSec

2

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

SessionTimeout

SessionTimeoutMinutes

20

Session timeout (minutes)

UseIpV6

UseIpV6

false

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

ValuesToBeDeletedPerMinute

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

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

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 appsettings.json

Info

Requirement: elproMONITOR Service is started!

  • In the elproMONITOR installation folder (C:\Program Files\ElproMONITOR), open appsettings.json file for Editing and in ElproUserUri field, enter the web client alias in-between the parantheses from >> 6.3.3 elproUSER Client einrichten (IIS).

  • After the changes in the file, the following actions are necessary:

    • Restart of elproMONITOR Service

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 management software requires a path to elproMONITOR’s install directory (usually C:\Program Files\elproMONITOR). 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 browse the path.

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

Info

From 3.1.0 this procedure is different for elproMONITOR.
ElproUSER, and elproEVENT still requires the old tenant path to configure database connection (usually C:\ProgramData\ELPRO\License).

10.1. Create XML Setting

image-20240621-134809.png

image-20240621-134923.png

Load file appsettings.json

image-20240621-135203.pngimage-20240621-135431.png
image-20240621-134745.png

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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