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Introduction to EMS

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EMS - Description

EMS - Functionality

EMS - Main Concepts and Architecture

EMS - Management and Monitoring of 3rd Party Control Equipment

EMS - Remote Management Tools

EMS - User Names and Passwords

EMS Compliant

EMS - Description

EMS Provides a Browser Based Graphical User Interface (GUI) for Hanwell Wireless Monitoring Installations.

EMS uses an SQL database making it easy to quickly and efficiently manage and access large amounts of data.

EMS is Scaleable

EMS offers a wide range of User options and configurations, ensuring future proofing and ready customisation to the User's particular circumstances.

Given the necessary permissions, EMS allows the User to rapidly change options and configuration details.

EMS gives you control of Exception Handling Protocols; the various options do not have to be generically configured by the Administrator.

EMS is a Services-Based System.

The EMS architecture ensures that support for as yet unknown hardware can be readily integrated (future proofing) by modularising the hardware services and accessing the database via a universal interface module.

EMS - Functionality

EMS has two key strands of functionality:

Extensive Reporting and Logging capabilities with custom reports available as easily accessible plug-ins to the main System and the capability to transmit Alerts.

The ability to act as an interface between Hanwell wireless monitoring equipment and 3rd party control equipment such as Motorised Valves and Alarm Sounders.

EMS - Main Concepts and Architecture

EMS Overall Layout

Figure 3

Overall Structure of EMS

EMS - Inputs

EMS - Data Input and Handling

Hanwell Radio Sensors and Loggers

Control Devices

Other Control Devices

Sites, Zones and Groups

EMS introduces the concepts of Sites, Zones and Groups

Sites

Zones

Groups

EMS - Outputs

Sensor Data Viewing and Reporting

Viewing Sensor Data

Reporting Sensor Data

User Alerts

EMS - Management and Monitoring of 3rd Party Control Equipment

MS1000 Control System

The Hanwell MS1000 Control System provides an interface between EMS and 3rd party control equipment and alarm sounders.

EMS - Remote Management Tools

The EMS Remote Management Tools are a collection of applications that enable direct Communication Setup and Configuration tasks that cannot be performed from a browser.

EMS Remote Management Tools are a collection of applications that enable EMS Administrators direct access to the EMS Server to perform Communication setup and Configuration tasks on the EMS Server that cannot be performed from a browser.

Using these Tools,  Communication setup and Configuration tasks on the EMS Server can be performed on computers on the LAN, local to the EMS Server, or on computers that are remote from the EMS Server.

For example, EMS Remote Management Tools would enable EMS Administrators to synchronise Sensors and setup SR2s on computers that are remote to the EMS server.

Note:EMS Remote Management Tools require http (Port 80) or https – where EMS System is configured for https - connection to the EMS server.

EMS - User Names and Passwords

Because EMS’s Primary User Interface is browser based, allowing Users to connect from any browser on the local network and, potentially, from remote locations as well, all Users must login with a User Name and Password.

EMS Passwords are case sensitive, EMS User Names are not.

Note:'@' and '-' symbols are allowed in User Names.

EMS Compliant

EMS Compliant incorporates features which meet the security requirements of FDA 21CFR Part 11.

FDA 21CFR Part 11 is an FDA (US Food and Drug Administration) regulation regarding the security of electronic data records; including the electronic signature on a record.

EMS Software (W906A and W906B) can be supplied with an FDA 21CFR Part11 licencelicense(W901) that activates the features required for Compliance with FDA 21CFR Part11, thereby ensuring that the electronic records - either in the form of the data records or in the form of the event log / audit trail - cannot be altered and any attempted tampering will be flagged.

For details on applying the W901 licence,licensesee EMS Software Licencing - Counter Signatures (W901 Only).

See also:

Hanwell EMS Compliant User Manual. Document Number: IM6148

EMS FDA 21 CFR Part11 & Validation User Guide. Document Number: SV6155

Note:When installing 21CFR Part 11 Compliant software the correct Hardware and Software Installation Qualification (IQ) and Software Operational Qualification (OQ) workbooks must be completed at the time of installation.
 
When upgrading any 21 CFR Part 11 Compliant software the correct Software upgrade IQ and OQ workbooks must be completed at the time of installation.

Differences between EMS Compliant and EMS Standard.

Confirming Activities - Minor Changes

Activities which alter System Operation or affect data recording and result in Audit Trail entries in the Activity Log, require confirmation.

These activities include:

Acknowledging Alarms.

Setting Alarm Levels.

Changing User Alerts.

Changing Scheduled Reports.

When such changes are submitted by the User, the Login control window will be displayed. See Figure 4 below:

Authorisation Required Window

Figure 4

The User is required to enter their password into the Password field and click Submit to confirm the changes.

Confirming Activities - System Changes

Activities which lead to system wide or significant configuration changes also require Counter Signatory confirmation.

These activities include:

User Management.

User Group Management.

Device Configuration.

System Configuration.

Editing Sites.

Changes to Access Control.

When such changes are submitted by the User, the Counter Signatory control will display. See Figure 5 below:

Counter Signature W901

Figure 5

This requires the currently logged in User to enter their password into the Password field.

In addition, a User who has Counter Signature Access Control permission must then:        

1.Select their User Name from the User Name (Counter Signatory) dropdown list.

2.Enter their password in the Password (Counter Signature) field.

3.Click Submit to confirm.

See Figure 5 above.

Turning off Counter Signatures

As stated above, with Compliant EMS installed and a W901 Licencelicenseapplied to it, you will have Counter Signatures applied to your system and turned on by default.

You have the ability to turn off the Counter Signatures using the EMSConfig utility. See EMS Software Licencing - Counter Signatures (W901 Only).

Scheduled Reports

Some EMS Reports include additional information to assist with CFR21 compliance and have a Signature version, which includes Signature and Comment boxes to aid with CFR21 compliance.