The Challenge

A leading pharmaceutical packaging company planned to migrate their outdated Building Management System hardware which controlled and monitored their freezers, coolers and packaging suites to their existing BMS system. The monitored temperature controlled spaces contained product during the migration.  In addition, the software for the AHU for the packaging suites was also upgraded.

The Solution

Performance Validation provided a dedicated Validation Engineer experienced in the delivery and execution of validation documentation for the Building Management System.

The PV Validation Engineer provided complete support for the project including authoring the change control, FMEA risk assessment, project management support, necessary system documentation and enhanced monitoring of the temperature controlled spaces during the changeover.  Working closely with the client’s engineering team, the vendors, and quality assurance personnel the PV Validation Engineer followed their established validation procedures to deliver the necessary system documentation and testing while minimizing risk to the stored product.

To reduce risk to product during the implementation, the project was divided into two phases so that the changes associated with each phase could be verified quickly.   PV provided risk mitigating monitoring of the controlled storage spaces during the migration and completed critical verifications immediately upon implementation to ensure the monitoring and alarm functionality were acceptable in the same day. PV also created test cases to verify the AHU software functionality was acceptable after the migration.

The Installation and Operational Qualification verified:

  • The temperature controlled units remained within specification during the migration
  • The parameter values were acceptable, alarms were functional and historical data was being properly archived and retrieved immediately upon start-up
  • Firmware and Hardware were properly installed
  • Code met the user defined requirements and performed calculations properly
  • Each point and graphics were properly configured
  • Connection integrity of each component
  • Critical instrument calibrations were completed
  • Security met the revised user defined requirements
  • AHU sequence of operations was per specification
  • The system responded as expected to alarm conditions
  • Historical data was being collected and could be successfully retrieved
  • The temperature distribution in the packaging suites controlled by the AHU

Project deliverables included:

  • Change control management using TrackWise
  • Necessary SOP revisions associated with the change
  • Validation Plan
  • FMEA Risk Assessment
  • Impact Assessment and Categorization
  • User Requirements for the BMS and AHU (revisions)
  • Trace Matrix showing traceability to user requirement acceptance criteria
  • Phase I and Phase II Installation and Operational Qualifications including temperature monitoring of the impacted controlled temperature units/suites and AHU operation and performance
  • Final Validation Reports

The Results

Final Validation Reports and the Change Control were delivered on time and each phase was released to operation as scheduled.

The Benefits

The quality of the documentation of the existing Building Management System was improved.  The freezers, coolers and packaging suites were successfully migrated to the existing Building Management System which provided the client with a more robust, updated, and compliant solution.

For more information please, schedule a call with one of our subject matter experts. 

Brad Henry
Vice President, Division Director, Indiana
Performance Validation, Inc.

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