Upgrading a Legacy System to Meet Modern GMP Expectations
A global pharmaceutical manufacturer sought to modernize its Building Management System (BMS) —including a Qualified Building Management System (QBMS) module used for quality impact systems— to enhance reliability, standardize automation across global sites, and ensure continued GxP compliance.
Performance Validation (PV) was engaged to support a site-wide transition from Siemens-based controls to a more robust Rockwell Automation platform. Since 2021, PV has delivered commissioning, qualification, and validation (CQV) support across eight programmable logic controllers (PLCs) and more than 40 systems, guiding the facility through every stage of the upgrade while maintaining regulatory compliance and production continuity.
Complex Integration and Documentation Gaps Created Early Challenges
The site’s legacy Siemens system lacked the stability and scalability needed for future growth. Migrating to Rockwell introduced new technical and procedural hurdles:
- Interconnected systems: The BMS was fully integrated, meaning a single alarm or shutdown could impact the entire site.
- Incomplete design documentation: Engineering deliverables often failed to align with the as-built configuration, leading to rework and deviations.
- Limited qualification windows: GMP-impact systems could only be tested during scheduled production shutdowns, compressing testing timelines into long nights and weekends.
- Vendor coordination: Multiple stakeholders—including Rockwell Automation and CRB project engineering—required clear communication channels and aligned review processes.
PV’s role was to bring structure, traceability, and compliance discipline to a fast-moving, multi-party automation project.
A Four-Phase Approach to Achieve Reliable, Compliant System Modernization
Phase 1 – Planning and Validation Strategy
PV developed a comprehensive validation plan outlining all systems, associated risk levels, and deliverables. The plan defined approval pathways, documentation standards, and traceability expectations from the outset.
Phase 2 – Design and Documentation Development
Working closely with the client’s automation and quality teams, PV helped author and review critical lifecycle documents, including:
- User Requirement Specifications (URS)
- Quality Risk Assessments
- Functional and Detailed Design Specifications
- Electronic Records and Signatures Assessments per 21 CFR Part 11
- Traceability Matrices linking user requirements to functional design and qualification testing
Phase 3 – Commissioning and Qualification Execution
PV executed rigorous testing to confirm proper installation, functionality, and data integrity. Activities included device I/O verification, communication and alarm testing, HMI usability testing, data transmission verification, and system backup/restore checks.
For GMP-impact systems, PV conducted full qualification within planned shutdowns, ensuring no loss of product monitoring or data integrity.
Phase 4 – Continuous Improvement and Ongoing Support
As the project evolved, PV helped implement a pre-approval document review process with Rockwell and CRB, catching discrepancies before approval and minimizing deviations. PV also supported the decommissioning of legacy systems and the onboarding of new equipment such as environmental chambers for stability programs, maintaining a validated state across the site.
Collaboration Transformed Project Obstacles into Lasting Improvements
During initial execution, documentation mismatches from the vendor created repeated deviations. PV’s detailed reviews and real-time feedback identified configuration errors, leading the client to add PV as part of the design-phase review panel.
Another early challenge arose when the client attempted to test all PLCs simultaneously—resulting in cascading alarms and shutdowns. PV’s recommendation to validate one system at a time prevented future downtime and streamlined testing. Through persistent communication, weekly project meetings, and robust record-keeping, PV helped realign the project schedule and re-establish stakeholder confidence.
Delivering a Fully Modernized and Commissioned and Qualified BMS
- Complete system modernization: Full transition from Siemens to Rockwell PLCs with more than 40 systems commissioned (BMS) or qualified (QBMS).
- Improved reliability and data integrity: The new BMS and QBMS meets 21 CFR Part 11 requirements for audit trails and electronic signatures.
- Enhanced efficiency: Pre-approval reviews and standardized templates reduced deviations and accelerated qualification cycles.
- Ongoing partnership: PV continues to support site expansions and system integrations, ensuring a sustainable state of control.
Lessons Learned: Early Involvement Drives Long-Term Success
This project reinforced the value of integrating validation experts early in the design process. By pairing engineering innovation with validation rigor, the client gained a more robust, compliant, and maintainable automation platform.
What began as a challenging system migration evolved into a repeatable, risk-based model for future site improvements—demonstrating how Performance Validation helps clients move quality forward through every phase of system modernization.
