2017/11/16 P a g e 1

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1 2017/11/16 P a g e 1

2 Contents What s New... 2 Fixes... 3 Driver Updates... 3 New Sensors... 3 New Features... 3 How To... 4 Security... 4 Auditing... 6 Smart UI/MAPS Title 21 CFR Part 11 Auditing... 6 Historical Alarm Views... 7 Alarm Reminder... 8 Adroit Technologies... 9 What s New EMS Version: 3.1 EMS Release: 2.0 Release Date: 2017/11/15 Copyright Adroit Technologies END-USER LICENSE AGREEMENT FOR Adroit SOFTWARE 2017/11/16 P a g e 2

3 Fixes More checks were added to all input boxes to validate user input (Excluded characters./\<>-*&, ). Please note that when the excel import utility is used, all verifications are bypassed. The alarm reminder (popup) could lose focus which resulted in the window no being accessible. This has been resolved, the reminder window will be modal across all applications. The dynamic navigation bar in the EMS project return a blank control when the dynamic graphic builder option was executed while open. Improvements were made to this effect. System XML file has been updated to set the Housekeeping property of the Alarm Management agent to 365 days as default. The backup head selector was restricted to select only available sensors on the same level\section. The Backup head selector now has a BackupSensorDepth property that will limit the list of available sensors down to set hierarchy. When the trend scroll lines option were used, the control returned blank. EMS hotfix addressed this by setting the ShowScrollLineMarkers property to false. Scan address fixed in xml for Ningi P16 controller Calibration Due on Ningi P50 devices addressed Alarm reminder now indicated the process value rather than the alarm bit as reported data value Addressed the reasons and notes form where the note section was obscured Fixed the reason and note control where an error returned while the list was empty Disabled advanced filtering on the sensor faceplate, historical alarms tab. This option enabled the user to filter across sensors while on a specific sensor faceplate. The historical alarm view return all sensor alarms for the last 2 weeks as default Driver Updates Fix on Aerview serial driver (rev 20) addressed critical transport layer error which required agent server restart. Internal priority stack were added to the jobs que Update to the Spero Ethernet driver (SPEROETH rev 30) New Sensors Added a standard UV-IR sensor New Features All relevant EMS documentation and manufacturer supporting documentation is now available from the Smart UI Operator under the Help>Documentation menu for easy access. The system lists all documentation and path structures from C:\ProgramData\Adroit Technologies\Adroit\SmartUI\Configurations\ Default\EMS\User\Documentation Users can navigated directly to the sensor faceplate from any alarm list by double clicking on the alarm. Manage EMS security and privileges from a single interface; apply default EMS security through the AEMS Datasource. By default 3 standard EMS user groups are configure. Enable SmartUI auditing for tracking set point and sensor attribute value changes. This forms part of the 21 CFR Part 11 compliance standard which also extends to change authorisation. The EMS install now load AEMS Datasource and required project files by default. 2017/11/16 P a g e 3

4 EMS configuration now allows for the automatic configuration of the DumpConfig agent with all relevant export agents for EMS configuration reports and additional diagnostic reports. Addition and configuration of a standard OLEDB Datasource linked to the historical alarm viewer. The ems datasource under site configuration is shared. New historical alarm view form is available from the Alarm Menu>Historical menu to quickly access a list of historical sensor alarms. The control extends various filter, export and print options. The EMS system added a new alarm route for all events, which can be viewed from the Alarm Menu>Event List menu. This typically represents operator actions such as triggering the evacuation state from the sensor faceplate. The alarm reminder (popup) now has the extended feature to change the back colour either by a set value or driven by a collection based on alarm priority(default) How To Security The Smart UI security system is user-centric and operates on top of the traditional Windows operating system security. This is made possible by using a configurable sub-set of the existing users and groups on each Server computer, known as the "allowed" users and groups, which provide the first or foundational level of ALL security and user management within the Smart UI; hence their creation is mandatory for every Server The Smart UI Server normally implements security, which is configured by the Security component of the Management category in the Enterprise Manager, as follows: Select which of the available users and groups on this Smart UI Server computer are "allowed" to log on to and interact with the Smart UI Server. The following additional Smart UI Server-specific security measures can be implemented for these allowed users and groups: Data element security: control the access to each data element and configured datasource Special function security: control the access to each special function optionally provided by a datasource plugin Policies control the access to this Smart UI Server and to each of its supported datasource plugin Project and Graphic form security control the access to or though objects within a project The EMS data source now automatically configures all relevant security and permissions based on a default set NOTE: It is strongly recommended that the 3 user groups (EMS_Operators, EMS_Maintenance and EMS_Administrators) are added to the local server and domain users and or groups are then added as members. Ensure this is available before the EMS system is configured 2017/11/16 P a g e 4

5 To enable and apply security 1. Right click on the AEMS Datasource and select Edit connection 2. From the Available users box, move all required users/groups to the Allowed box 3. Select the user/group from the Allowed box and apply the appropriate permissions by selecting Read; Write and Acknowledge alarms check box 4. Repeat for all users/groups 5. Right click on the EMS hierarchy under AEMS Datasource and choose Apply Security NOTE: The available users are a list off all users and groups based on the work group or domain specified in the Adroit Config editor. Default graphic form security is applied to EMS_Operators, EMS_Maintenance and EMS_Administrators groups. Figure 1: AEMS Datasource security 2017/11/16 P a g e 5

6 Auditing This version of the EMS introduce us to the Smart UI auditing which forms part of the 21 CFR Part 11 compliance standard. All Smart UI data element (agent.slot) that are managed though the EMS interfaces are configured to be audited. Therefor any value or state change will be logged to the internal audit table. An option exist to further log the audit records to an external OLEDB database, discussed later in this section. This will include set point changes, custom tag value changes etc. This is supplementary to the Adroit server auditing and tag auditing options. Auditing options are managed through the sensor xml files <audit=true> When the user selects the Add Agents command from the AEMS Datasource, the system will now respond with a form request to apply security. Based on the user input security and auditing will be applied Figure 2: Apply Security request On an upgrade system, it is required that the user invoke the apply security from the AEMS Datasource hierarchy to both enable auditing and apply default security. Smart UI/MAPS Title 21 CFR Part 11 Auditing Title 21 CFR Part 11 (21 CFR 11) of the Code of Federal Regulations deals with the United States Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures (ERES). This defines the criteria and circumstances under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records by the FDA. When it is enabled it denies external access to the Agent Server. It requires at least 2 operators to be able to modify/change set points and the operators must have write access to the set points or authorize. One operator initiate the change the other authorize the change, the authorization details are logged and shown in the Smart UI Authorization Detail report. The Smart UI/MAPS have the capability to log audit writes of data elements (Agent.slot). The logged details can be viewed in the Smart UI Audit activity report. This is similar to the Adroit tag auditing, but executed on a data element in the Smart UI instead. The Apply Security option in the EMS system enables auditing and authorisation on specific data elements (slots) defined in the sensor xml files. By default authorisation is disabled <audit=true authorisation=false> Enable authorisation by editing the required tags in the xml files or directly on the data element security. 2017/11/16 P a g e 6

7 To enable 21 CFR 11 auditing: 1. Open Adroit Config Editor 2. Click on Setting up the Server 3. Click on Security Settings 4. Under Title 21 CFR Part 11 Compliance, select Yes and type in a password. This password will be used to disable 21 CFR 11 auditing as well. 5. Select Yes in the next section under Auditing to save all the records to a secondary SQL database and set up the connection string. Figure 3: Adroit Smart UI Editor Historical Alarm Views Display alarms for the last 7 days ranked by date for all sensors. This list can then be navigated though or analysed by reordering data, apply additional filters or expand the selection criteria. Final results set can be exported to excel or printed. The data is refreshed manually thought a refresh button on the toolbar. Figure 4: Historical Alarm View 2017/11/16 P a g e 7

8 Alarm Reminder Figure 5: Alarm reminder with priority colours To modify the back colour; 1. In the Smart UI Designer, open the EMS Landing Alarm graphic form 2. Select the alarmreminder object from the properties window (locate the alarmreminder control at the bottom and select) 3. Under advanced properties, set the UsePriorityColor to true 4. Edit the PriorityColors collection 5. Save the graphic form Figure 6: Enterprise manager properties 2017/11/16 P a g e 8

9 Adroit Technologies STREET ADDRESS: 20 Waterford Office Park 189 Witkoppen Road Fourways Johannesburg South Africa TEL: +27 (0) FAX: +27 (0) GENERAL ENQUIRIES: SUPPORT ENQUIRIES: WEBSITE: /11/16 P a g e 9

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