Conversation That Matters
No deviation’s Takeaways from KNEAT VALIDATE 2025: accelerating digital maturity
Topic: Identifying and Controlling CQV Costs in the Digital Era
Speaker: Patrick Mullin – Commissioning and Qualification Lead -Sanofi
“The low-hanging fruit is gone.”
That’s how Patrick Mulin, opened his session at VALIDATE. And from the moment he said it, the tone was set: this wasn’t another talk about going digital—it was a deep dive into what comes after.
Morgan O’Brien, CQV Director at No dDeviation, was in the room.
“What Patrick delivered wasn’t just a recap of digitisation wins,” Morgan recalls. “He brought a fully operational cost-control model into the spotlight—and showed us how CQV can evolve into a performance-driven, financially visible function.”
From Tools to Transformation
Sanofi began digitising CQV documentation in 2018, deploying tools like Kneat to reduce document handling time and streamline workflows. But as Patrick pointed out, these efficiencies are now considered standard.
“We can’t call it savings anymore,” he explained. “They’re embedded in every project plan. So, where do we find the next layer of value?”
Enter Project Controls—and Earned Value
The shift came when Sanofi’s Project Controls mandated that all CQV capital project activity must be digital. This elevated CQV from a compliance role to a cost-and-schedule stakeholder. The team adopted Earned Value Analysis (EVA), breaking down each CQV deliverable—drafting, execution, review—into monetised units.
“We moved from tracking documents to tracking performance. Once every step has a value, you can measure real progress against forecasted effort and cost.”
For Morgan, this was a turning point:
“Patrick showed how EVA gives CQV professionals hard data. Not just on what’s done—but on how we’re performing. And more importantly, where delays are really coming from.”
Metrics That Matter
Sanofi’s model centres around two key KPIs:
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Cost per protocol
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CQV as a % of direct capital cost
“When benchmarked properly, these metrics let you forecast within 10% accuracy—even before protocol count is finalised,” said Patrick. This approach also improves vendor evaluation, resource planning, and internal alignment.
Morgan adds:
“These metrics cut through the noise. They let CQV speak the language of finance and project delivery. That’s a game-changer.”
Data-Driven Influence
Perhaps the most powerful moment came when Patrick described using EVA data mid-project to demonstrate that CQV was not the bottleneck.
“For once, we could breathe,” he said. “We had completed the work—but construction wasn’t ready. EVA helped us highlight that, and shift the narrative.”
This visibility gave CQV teams new influence. Not by lobbying—but with facts.
What’s Next? ROI, Not Just Ideas
Looking forward, Sanofi is exploring:
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AI-assisted protocol development
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Automation of trace matrices and system impact assessments
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Digital handover processes to shorten site time
But Patrick made one thing clear:
“If data-centric CQV is going to deliver more savings, we need a clear ROI. Not a concept—a number I can take to leadership.”
In Conversation, There’s Progress
At No deviation, we believe these kinds of conversations move our industry forward. From cost per protocol to EVA models, Sanofi’s example shows how CQV can earn its place as a value-generating discipline—grounded in metrics, integrated in project control, and ready for the next level of digital maturity.
Want to go deeper?
Contact us at hello@nodeviation.com and let’s have a conversation… that matters.
That’s very interesting.