CQV Documentation & Validation Support
Apex-level CQV governance through to execution — Master Plans, risk assessments, and URS-through-PQ protocols for facilities, utilities, equipment, and computerized systems.
CQV work lives or dies on the documents underneath it. I’ve authored apex-level governance documents — CQV Master Plans, System Level Impact Assessments, and Quality Risk Assessments — and carried them through to URS, FAT, SAT, IQ, OQ, and PQ execution across facilities, black-and-clean utilities, process equipment, and computerized systems.
That work spans oral solid dose, oral liquid, injectable/sterile, biologics, and vaccine environments, delivered across India, Thailand, Vietnam, and the UK — including leading CQV execution at a government-owned pharmaceutical manufacturing site in Southeast Asia, commissioning and qualification of a sterile manufacturing facility in Newcastle, UK, and direct involvement in the international technology transfer of a Hepatitis-B r-DNA vaccine process from Cuba to India. I bring the same rigor to a single equipment qualification as to a full facility CQV Master Plan.
How it works
- 1
Design review & URS
Translate user requirements into a validation-ready URS before design freezes.
- 2
Risk & impact assessment
SLIA and QRA to focus validation effort on what's actually GMP-critical.
- 3
Protocol authoring
FAT, SAT, IQ, OQ, and PQ protocols written for real execution, not just approval.
- 4
Execution oversight
On-site or remote oversight through execution, with deviations resolved as they happen, not weeks later.
- 5
Validation summary & release
A validation summary report that stands up to review and supports system release.
Related services
QMS Design & Implementation
Building a Quality Management System from the ground up — Quality Manual through SOPs — aligned to GMP, ICH Q10, and ISO 9001:2015.
- Quality Manual and Quality Policy
- Site Master File (SMF)
- Tier I–III document architecture (Quality Manual → SOPs → BMR / BPR / work instructions)
QMS Audit & Review
Independent, line-by-line review of an operating QMS — so weaknesses surface on your terms, not a regulator's.
- Document-by-document QMS review report
- CAPA effectiveness and closure-quality review
- Deviation and change-control trend analysis
Gap Analysis & Audit Readiness
A dry run of your next regulatory inspection — mock audit, documentation review, and shop-floor walkthrough — so findings surface before the real one.
- Mock inspection in the style of your target authority (USFDA / WHO / EU-GMP / CDSCO)
- Facility and documentation gap report, classified critical / major / minor
- CAPA plan with owners and realistic timelines
Let’s talk
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