Driving Efficiency: Streamlining the Qualification of 15 BSCs with QRM, Project & Vendor Management
Brevitas streamlined the qualification of 15 Biosafety Cabinets (BSCs) by applying Quality Risk Management (QRM) principles and structured vendor oversight. Tailored protocols were aligned with the User Requirements Specification (URS) to ensure compliance, reduce redundancy, and deliver cost-effective results within a compressed timeline.
Business Challenge
The client faced challenges in qualifying 15 Type A2 BSCs of various sizes (4 to 6 feet) for their Cell and Gene Therapy facility. Key risks included incomplete URS coverage in vendor protocols, limited execution time, lack of GDP awareness among vendor resources, and resource conflicts—leading to inefficiencies that jeopardized project timelines and regulatory compliance.
Our Approach
Brevitas implemented a structured, risk-based approach to streamline execution and ensure compliance. Key strategies included:
- Risk-Based Testing – Evaluated vendor protocols and leveraged strategic equipment relocation to optimize execution and reduce testing workload.
- Vendor Management – Conducted alignment meetings and delivered GDP training to ensure protocol execution met client expectations.
- Protocol Development – Leveraged vendor protocols to develop wraparound protocols, ensuring complete URS alignment without redundant effort.
- Project Scheduling – Executed select testing activities at a temporary location and coordinated all resources to identify early-start opportunities and maximize schedule efficiency.
- Real-Time Oversight & Proactive Risk Management – Enabled rapid issue resolution and maintained GDP compliance through continuous monitoring.
Results Achieved
From initiation to completion, the Brevitas team played a critical role in the project’s success, as evidenced by the following outcomes:
- Successfully qualified all 15 Biosafety Cabinets, minimizing delays and controlling costs.
- Achieved full URS coverage through the development of compliant wraparound protocols.
- Delivered the project on time and within budget.
- Mitigated risks proactively using structured QRM methodologies.
- Maintained the integrity of vendor qualifications through continuous oversight and coordination.
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