A biomedical research company purchased a web enabled enterprise wide building management system. The Trane Tracer Ensemble software allows remote access to monitor and troubleshoot building systems from a PC or phone device. They installed environmental sensors for rooms, refrigerators, and freezers which send alerts in the event of a failure. Since they were running nonclinical studies on-site there was a need to validate the software. The company did not have much validation experience and wanted to make sure the web based application would be compliant for future audits of their study data.
Performance Validation (PV) used their experience with the computerized system in accordance with 21 CFR 820 (FDA Quality System Regulation) and 21 CFR Part 11 (Electronic Records, Electronic Signatures) to assist getting the software validated.
The PV Advantage
Performance Validation’s (PV) had experience validating multiple ‘hosted’ systems and have worked on several environmental monitoring systems. This experience helped expedite the validation efforts and kept their validation project on schedule.
PV met with the vendor with the client to see a software demonstration and overview their qualification documentation. Using this documentation and assisting writing a vendor evaluation allowed the client to leverage installation qualification documentation. The validation focused exclusively on Performance Qualification (PQ) testing.
Remote communication was necessary to help the client develop a Requirements Specification documentation. The Validation plan and system assessment identified a several procedure updates were necessary. These SOP’s were listed in the assessment and their details were included in the Validation Summary Report.
A test instance of the software was given to PV to allow writing of test steps. PV managed to write a majority of the testing documentation independently. Remote sessions were then set up to complete the remaining test protocol drafting. PV then worked on remotely executing all the protocols and creating a traceability matrix. The testing verified connection of the software to the temperature and humidity probes/sensors, creating reports, establishing and testing alarms, and verifying audit trails.
The PV CSV team used their previous experience with environmental monitoring systems, and vendor hosted software to ensure their client validation project met the timeline and would be compliant for future auditor and FDA acceptance. The validation was completed almost entirely remotely and this kept expenses low, reduced down time, and assisted the project with staying on time.
Performance Validation provided their client experience and knowledge to get their environmental monitoring system validated. PV’s assistance evaluating the vendor and leveraging their documentation allowed the validation project to go smoothly and ensure 21 CFR 11 compliance.