A non-clinical research organization in West Michigan required Environmental Monitoring System (EMS) validation and Building Management System (BMS) validation to support Good Laboratory Practice (GLP) compliance. Performance Validation partnered with the organization to validate its newly installed monitoring and automation systems, ensuring regulatory compliance, audit readiness, and reliable environmental control.
Leveraging Extensive Expertise for Seamless Validation
Performance Validation (PV) executed the project by leveraging their extensive expertise in validation processes and remote collaboration. The client, a CRO in West Michigan, had recently completed a large expansion and required an Environmental Monitoring System (EMS) and Building Management System (BMS) to ensure GLP compliance. Given their positive experience with PV’s previous lab instrument validations, the CRO trusted PV to manage this critical project.
The equipment used included the Trane Tracer Ensemble, Tracer SC+ Building Automation System (BAS), JACE controllers, thermostats, hygrometers, pressure differential sensors, and a handheld phone application. These systems were essential for maintaining precise environmental controls within the facility’s study areas.
PV’s approach began with an on-site visit to the CRO’s facility, where they received training from the vendor, Trane. This training included an overview of the equipment, the Installation Qualification (IQ) details and answering a vendor questionnaire to assist with vendor evaluation documentation. With this foundation, PV developed a comprehensive validation plan remotely, which included a Computer System Risk Assessment, User Requirements Specification, Traceability Matrix, and Validation Summary Report.
The decision to perform much of the work remotely was driven by the Ensemble software’s web browser accessibility and its SaaS (Software as a Service) setup, which facilitated efficient remote assistance. This approach not only expedited the project timeline but also resulted in cost savings for the client.
PV’s familiarity with the CRO’s approved validation forms and the success of previous collaborations cemented their role in this project. By creating detailed documentation and leveraging remote tools, PV ensured that the validation process was thorough, efficient, and aligned with regulatory requirements. This methodical execution helped the CRO achieve GLP compliance seamlessly, enabling them to focus on their core research activities.
SERVICES PROVIDED
| Environmental Monitoring System (EMS) Validation | Validation Test Script Development and Execution |
| Building Management System (BMS) Validation | 21 CFR Part 11 Compliance Verification |
| Computer System Risk Assessment | Validation Summary Reporting |
| User Requirements Specification (URS) | Change Control Support |
| Traceability Matrix Development |
Careful Analysis and Prompt Resolution to Ensure Success
During the project, several issues arose that required careful analysis and prompt resolution to ensure the successful validation of the Environmental Monitoring System (EMS) and Building Management System (BMS).
One significant issue was the discovery of a missing Part 11 compliance component in the software during the writing of the validation test scripts. Part 11 compliance is crucial for ensuring that electronic records and signatures are trustworthy, reliable, and equivalent to paper records. This component had not been originally installed, which posed a potential risk to the system’s regulatory compliance.
Upon identifying this gap, the client promptly purchased and added the necessary Part 11 compliance component to the software package. This addition required an update to the validation plan and the User Requirement Specification (URS), as well as the creation of additional test scripts to verify the new component’s functionality and compliance. The inclusion of this component also provided further Installation Qualification (IQ) documentation from the vendor, which PV leveraged to ensure thorough and accurate validation.
Addressing this issue required close coordination between PV and the client. PV’s proactive approach in identifying the missing component and swiftly integrating it into the validation process demonstrated their commitment to maintaining high standards of compliance and operational integrity. This experience underscored the importance of comprehensive initial assessments and the need for flexibility and adaptability in handling unexpected challenges.
PV’s adaptiveness and proactive approach streamlines processes
Throughout the project, Performance Validation (PV) encountered several challenges that provided valuable lessons for future endeavors. One significant issue was the difficulty in scheduling time with facility subject matter experts (SMEs). The new building’s ongoing operational setup and additional connections often made it hard to coordinate with the necessary personnel. To address this, PV recognized the importance of setting up recurring meetings early in the project timeline. This proactive approach would help maintain consistent progress and ensure that all stakeholders remain aligned.
Another challenge was the time-consuming process of signing documents via print, scanning to PDF, and emailing. This traditional method of document approval significantly slowed down the project. In response, the client later adopted an electronic signature platform, which expedited the document approval process. This transition not only saved time but also streamlined the workflow, allowing for faster and more efficient project completion.
Successful Validation and Ongoing Partnership
The project culminated in a successful validation of the Environmental Monitoring System (EMS) and Building Management System (BMS), meeting all predefined success criteria and metrics. The key metrics for success included comprehensive completion of all validation tests, approval of validation documentation, and seamless deployment into production.
After rigorous testing, all validation documentation was thoroughly reviewed, signed off, and officially deployed into the client’s operational environment. The validation process ensured that the EMS and BMS systems were compliant with Good Laboratory Practice (GLP) standards, which was critical for maintaining controlled and reliable environments for the client’s research studies.
The effectiveness of the validation was further demonstrated by the client’s ability to pass frequent audits conducted by outside sponsors. The validated systems consistently met stringent regulatory requirements, highlighting the robustness and reliability of the validation work performed by Performance Validation (PV).
The client’s satisfaction with PV’s work was evident when they expanded to a new building and once again enlisted PV’s expertise. PV was tasked with performing a change control to integrate new sensors and implement additional requirements, such as battery backup systems and continuous data collection during power outages. This follow-up project further solidified the successful partnership between PV and the client, highlighting PV’s ongoing commitment to quality and compliance.
Project Summary
Performance Validation (PV) successfully executed the validation of an Environmental Monitoring System (EMS) and Building Management System (BMS) for a non-clinical research organization in West Michigan. The project involved the use of the Trane Tracer Ensemble system to ensure compliance with Good Laboratory Practice (GLP) standards. Leveraging their extensive expertise, PV managed the validation remotely, utilizing detailed planning, risk assessments, and electronic document approval to streamline processes and overcome challenges. Despite encountering issues such as a missing Part 11 compliance component and scheduling difficulties with facility SMEs, PV’s proactive and adaptive approach ensured timely project completion. The validated systems not only met all regulatory requirements but also passed rigorous external audits, leading to continued collaboration as the client expanded their operations. This project highlights PV’s commitment to quality, compliance, and innovative problem-solving in the life sciences industry.
