Complete BMS and EMS Solutions

Data Logging and Audit Trail Designed to Satisfy FDA 21 CFR Part 11

Data Logging

Data logging is a key requirement for BMS/EMS systems. FDA 21 CFR Part 11 requires that logged data will be tamper proof and will include critical environmental parameters

(temperature, humidity, pressure, particulate sizes, etc), with audit trails including:

• Accurate time and date stamps
• Alarms and events
• User actions and details (e.g. setpoint changes)
• User notes
• Electronic Signatures
• Login/Logout

Eurotherm’s BMS/EMS systems log plant data to tamper proof files and SQL relational databases. Data logging can be offered as:

• Local logging (Tamper proof file)
• Central logging (SQL database)
• Local and central logging (Tamper proof files and SQL database)

The availability of logged data can be significantly increased by the local and central logging option. This allows data collection in multiple devices to further protect vital plant data.

Typically a BMS/EMS system comprises of a number of distributed units where each unit has its own internal clock. Time synchronisation is included to ensure accurate time and date stamps, as required by FDA 21 CFR Part 11, to a known clock source.

The BMS/EMS system offers provisions for electronically copying data for archive and export facility to common packages (e.g. Excel, Word, PDF, etc.) for viewing of secure records in human readable format. Other features of the system include:

• Power and network recovery automatic procedures
• FTP server to put the data on a central server
• Scheduled transfers

The system can be configured to provide logging for non-critical parameters including:

• System events
• Equipment failure
• Equipment performance and maintenance
• Energy usage

Alarms and Events Reporting

An important feature of the BMS/EMS system is its Alarms and Events functionality. All alarms and events are time stamped and logged for long term retention and validation to FDA 21 CFR Part 11. Individual plant data can be configured to have one or a combination of the following alarms:

• Absolute alarms
• Deviation alarms
• Rate of Change alarms
• Delayed alarms
• Excursion alarms

The system can be configured to provide other alarms including;

• Sensor break
• Equipment failures
• Network failure
• Maintenance and calibration alarm

Alarms can be configured as critical, non-critical or as an Event. Critical alarms will require manual acknowledgement and non-critical will be auto-acknowledged. Alarm selection and setpoint settings are available to the users with the appropriate access level and critical alarms can be configured to require an Electronic Signature for changes. Alarm acknowledgement and all changes to alarm settings are automatically logged as required by FDA 21 CFR part 11. All alarms and events are reported through local, central, and remote HMI panels. They are displayed in the Alarm Summary and Alarm History pages which provide a sort facility for the information. Alarms can be grouped by their criticality and function to ensure individual alarms can be quickly accessed.

Other features of the BMS/EMS alarm system include:

• Audible alarm notification
• Notification of alarm conditions to designated users on a designated telephone number
• Local printing of alarms and events

Easy to Use, Comprehensive Reporting

Review and Reporting

The BMS/EMS system provides a comprehensive review and reporting system. The system offers two methods for collecting data:

• Local data collection – Data collected locally in a secure format and archived centrally in a filing system
• Central data collection – Data collected in a central historical SQL relational database

These methods may be combined and, in both cases, the system provides the facility to create reports for individual rooms. A number of standard report templates are provided along with the facility for users to create their own reports.

Information can be automatically transferred and accessed from standard Microsoft® Office packages.

• Realtime and historical trends
• Multiple data plots
• Search by batch or by room
• Batch trend analysis
• “Golden Batch” analysis
• Standard and custom SQL queries
• Direct insertion to Excel™, Word™
• Quick report generation with standard templates

Maintenance and Calibration

Maintenance is an essential part of any BMS/EMS system. Maintenance information on various elements of the system (e.g. last calibration date, calibration due date, last maintenance date, maintenance due date) is shown on multiple displays throughout the system. The system can provide warnings if calibration/maintenance dates for individual equipment are approaching and/or exceeded.

Access permission can be given to individual users to select maintenance modes for the following:

• Sensors
• Equipment (e.g. pumps, motors, valves)

Maintenance mode can also be selected for a given area e.g. a room or a zone of the plant. While in maintenance mode the individual equipment or area will be clearly identified on the display using colour and text. The system can be set to suppress alarms and stop logging parameters for associated equipment at this time.

Selection and the de-selection of the maintenance mode will be logged as an event in the audit trail.

Easy to use calibration tools are included in the system for use during maintenance mode. Selection and de-selection of the calibration mode is logged in the audit trail.

Total Lifecycle Support

Remote Alarm Notification

Nominated users can be quickly notified of alarm conditions via the telephone system.

The system offers:

• Real-time alarm notification triggered from the plant system
• Ensured the delivery of the messages
• Easy to configure tools
• Login facilities and security patterns
• Redundancy options

Remote Monitoring

Remote users, including off-site, can access plant information via a secure web portal.

• Remote real-time data visualisation
• Multi language facilities
• Support for multiple windows
• Integrated information from diverse data sources

Services

Services need to be provided from the beginning of the project, though the project development and commissioning, and for the lifetime of the system.

Eurotherm offers a complete range of services such as:

• Expertise to assist with the User Requirement Specification
• Project, Application and Validation engineering
• Commissioning (e.g. calibration) and qualification engineering
• Training courses covering products, control theory, validation etc.
• Helpdesk and on call services
• Product services

Qualification/Validation

BMS/EMS

A key requirement for BMS/EMS solutions is validation. Where environmental conditions (e.g. temperature, humidity, differential pressure, air flow, sterility, containment) have a direct impact on product purity, safety, quality or efficacy they need to be monitored against predetermined limits and logged. In this case the BMS/EMS system used for collecting and logging the data needs to be validated. According to ISPE guidelines, it is good practice to monitor the performance of equipment such as fans, coil and control components, but it is not a regulatory requirement.

Documentation

Validation documentation needs to be provided through the cycle of the BMS/EMS system. Eurotherm can offer a range of documentation services following ISPE GAMP5 guidelines and in accordance with customer requirements:

• User Requirement Specification
• Functional Specification
• Design Specification
• Hardware Testing
• Code Review
• Factory Acceptance Test
• Installation Qualification
• Operational Qualification
• Periodic review

Mean Kinetic Temperature (MKT) (on the warehouse mapping only)

Calculation

Measurement and recording of temperatures is vital to the storage of perishable goods, but there is more than one way to record an average. The ICH defines the mean kinetic temperature as being “A single derived temperature that, if maintained over a defined period of time, affords the same thermal challenge to a drug substance or drug product as would be experienced over a range of both higher and lower temperatures for an equivalent defined period”.

MKT expresses the cumulative thermal stress experienced by a product at varying temperatures during storage and distribution. It differs from other means (such as a simple numerical average or arithmetic mean) in that higher temperatures are given greater weight in computing the average, recognising the accelerated rate of thermal degradation of materials at higher temperatures.

Eurotherm minimizes the implementation and operation cost of providing MKT data by making all of the above methods as integral part of our solution with:

• A choice of stability testing period (hourly / daily /weekly)
• A choice of sampling frequency (from 1 minute to 1 hour)
• Option to remove individual probes from the calculation (e.g. during a calibration process)
• Corrective action in case stability is out of specification
• Secure and low cost custom reporting