For decades, commissioning and qualification (C&Q) in pharmaceutical manufacturing has been shaped by a familiar structure: the V-Model. It’s orderly, heavily documented, and built on the idea that more testing equals more certainty.
But in today’s manufacturing landscape—where speed, flexibility, and regulatory clarity all matter at once—that model is starting to show its age.
A recent Career Catalyst session explores exactly this shift: how pharma teams are moving away from legacy, document-heavy validation approaches and toward a modern, risk-based commissioning and qualification strategy that is faster, leaner, and more defensible.
Why the Traditional V-Model Is Being Reconsidered
The classic V-Model approach often leads to:
- Duplicate testing across IQ, OQ, and PQ
- Heavy reliance on static documentation
- Late-stage validation activities that delay facility readiness
- “Testing for comfort” rather than testing for risk
While it has historically supported compliance, it doesn’t always reflect how modern facilities are designed, built, and commissioned today.
As manufacturing becomes more complex—and regulatory expectations evolve—the industry is increasingly asking a different question:
Are we testing everything, or are we testing what actually matters?
The Shift: From Testing Twice to Testing Once
The central idea discussed in this Career Catalyst session is simple but transformative:
Move from “testing twice” to “testing once,” by anchoring qualification strategy in risk.
This approach is grounded in Quality Risk Management (QRM) and supported by frameworks such as the ISPE Commissioning and Qualification Baseline Guide 5 Vol 2.
Instead of treating commissioning and qualification as separate, sequential activities, modern CQV teams are:
- Integrating engineering and commissioning deliverables as part of qualification evidence
- Defining system boundaries and classification earlier in the project lifecycle
- Aligning testing directly to system criticality and patient impact
- Focusing qualification effort where it reduces actual risk to product quality and patient safety
The result is not less rigor—but more intentional rigor.
What Risk-Based CQV Looks Like in Practice
A modern, risk-based CQV strategy typically starts much earlier than traditional validation execution. Key elements include:
1. Early system definition and boundaries
Clearly defining what constitutes a system—and how it will be evaluated—reduces ambiguity later during IQ/OQ execution.
2. System Risk Assessments (SRA)
These assessments determine where risk truly exists and where testing effort should be concentrated.
3. Early identification of CQAs and CPPs
By linking critical quality attributes (CQAs) and critical process parameters (CPPs) to design decisions early, teams can proactively reduce downstream validation burden.
4. Leveraging engineering and GEP documentation
Commissioning records, vendor testing, and Good Engineering Practice (GEP) deliverables are increasingly being accepted as meaningful evidence—when properly aligned to risk.
A Real-World Perspective on CQV Transformation
The session also highlights a practical implementation lens: how organizations actually transition from legacy validation approaches to risk-based CQV in live capital projects.
This is not a theoretical exercise. It requires:
- Cross-functional alignment between engineering, quality, and validation
- A shift in mindset from “document everything” to “justify everything that matters”
- Early collaboration between design, commissioning, and quality teams
When done effectively, organizations see measurable improvements:
- Faster startup timelines
- Reduced validation redundancy
- Stronger inspection readiness
- Clearer justification for regulatory submissions
Voices From the Field
The discussion features insights from two experienced leaders in CQV and manufacturing readiness:
Stephanie White, a pharmaceutical and biotech manufacturing leader with over 23 years of experience across organizations including Pfizer, Takeda, Amgen, and Emergent BioSolutions, brings deep operational and global validation governance expertise. Her work focuses on scaling CQV systems that are not only compliant, but sustainable—grounded in QRM and ISPE-aligned best practices.
Kayla Britt, M.S., a validation specialist and founder of Britt Biocomputing, brings a translational perspective from cell therapy validation and AI-enabled systems. Her focus is on ensuring that validation and acceptance criteria are not only technically accurate, but audit-defensible and aligned to real-world use.
Why This Shift Matters Now
Pharma manufacturing is entering a phase where:
- Facilities are becoming more modular and digitally integrated
- Product pipelines are more complex and time-sensitive
- Regulatory expectations emphasize science- and risk-based justification
In that environment, legacy validation models struggle to keep up.
Risk-based CQV isn’t just a process improvement—it’s becoming a strategic necessity for organizations that want to remain competitive while maintaining compliance integrity.
The Bigger Takeaway
Retiring the V-Model doesn’t mean retiring rigor.
It means replacing redundant effort with targeted assurance. It means shifting from documentation-driven validation to risk-informed decision-making supported by real engineering evidence.
And most importantly, it means aligning CQV execution with the real purpose of the system:
protecting patients, ensuring product quality, and delivering manufacturing readiness without unnecessary delay.
🎥 Full session here:
