Strategic Execution of Project CQV Programs to Achieve Regulatory Approval Under Deadline Pressure

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Jun 3
1 min read

Client Overview

In response to growing demand for seasonal flu vaccines, a global life sciences company launched a $150M+ expansion to increase fill-finish capacity at its U.S. campus.

The new 90,000 ft² facility included a pre-filled syringe line, inspection and packaging automation, and sterile utilities—all of which required integrated commissioning, qualification, and validation (CQV) to satisfy FDA scrutiny.

Challenge

Deliver a complex validation program under an aggressive deadline
Execute during pandemic constraints and shifting operational conditions
Ensure regulatory readiness without introducing delays or excessive rework
Prevent “scope creep” from over-engineered or overly complex validation protocols

CORE’s Role

CORE led the end-to-end CQV delivery, managing all critical phases including:

Design Qualification (DQ)
Validation planning and scheduling
Protocol writing, execution, and closeout
Cleaning and sterilization cycle development
Resource forecasting and system prioritization
Integrated commissioning and qualification leveraging risk-based methodologies

Our strategic approach allowed commissioning results to double as qualification evidence—reducing redundancy and compressing timelines.

Outcome

Performance Metric	Result
Project Schedule	Delivered on time, despite COVID-era constraints
Audit Result	Passed FDA inspection with no critical observations
Validation Efficiency	Reduced validation time and documentation burden by over 30%
System Readiness	Enabled uninterrupted vaccine delivery for the upcoming flu season

Conclusion

CORE’s structured, risk-based CQV execution proved that validation doesn’t have to be complex to be effective. By eliminating redundancy and aligning execution to regulatory priorities, we helped the client reduce both time and risk while ensuring full audit readiness.

Validation done right accelerates business outcomes.