Expert solutions to real challenges
Operational Readiness - where projects become products.
It’s the bridge between construction and commercial success. But getting there isn’t easy. It demands foresight, coordination and technical excellence.
Michael Sweeney, CQV Expert, PM Group sets out the top challenges facing the pharma industry and how to solve them.
“Readiness often starts too late. Teams tend to focus on construction and CQV"
Readiness starts too late
Challenge:
Teams focus on construction and CQV. Readiness planning gets pushed aside.
Solution:
Start early. Build Readiness into the project timeline. Align engineering, CQV, and operations from day one. Readiness is not a phase - it’s a mindset.
No clear ownership
Challenge:
Readiness spans multiple functions. But no one owns it.
Solution:
Appoint a Readiness lead. Create a cross-functional team. Use RACI charts to define roles. Ownership drives accountability.
Unmapped processes
Challenge:
Teams don’t fully understand how the facility will operate.
Solution:
Map every process. From material receipt to product release. Use digital tools to simulate workflows. Validate with end users. Clarity prevents chaos.
“Commissioning and Qualification (CQV) runs parallel - but not in sync - with readiness."
Michael Sweeney
CQV EVal Lead
CQV misalignment and data without insights are also common challenges. CQV should run in parallel - but not in sync - with Readiness. The challenge with data is that teams collect data - but don’t use it.
Solutions include integrating CQV into Readiness planning and using risk-based approaches. Align protocols with operational needs - qualified systems must support real operations. In terms of data, use digital platforms to track readiness metrics and monitor progress in real time. Share dashboards with stakeholders. Data should drive decisions - not just fill spreadsheets.
Training gaps
Challenge:
Operators are trained too late - or not at all.
Solution:
Develop training plans early. Use SOPs, simulations, and walkthroughs. Validate competency before go-live. A trained team is a ready team.
Documentation delays
Challenge:
SOPs, batch records, and validation reports arrive late.
Solution:
Start documentation in parallel with design. Use templates and assign owners. Track progress digitally to make significant time and cost savings. Documentation is a deliverable - not an afterthought.
Regulatory blind spots
Challenge:
Teams focus on technical readiness but forget regulatory expectations.
Solution:
Align with quality and compliance from the start. Prepare for audits and document everything. Regulatory success is operational success.
“Finally, with no Go-Live criteria, how will your teams know when they're ready?" ”
Michael Sweeney
CQV EVal Lead
“It’s about defining the Operational Readiness criteria. Use checklists. Validate systems, people and processes. Don’t guess - prove Readiness,” says Michael.
Operational Readiness is not a box to tick - it’s a discipline. With qualified CQV experts, digital platforms, and early planning, pharma manufacturers can move from build to batch with confidence. Plan early. Align teams. Track progress. Deliver with certainty.
Learn more about how we can help you with your Operational Readiness project delivered by our CQV experts.
