QMS Audit & Review
Independent, line-by-line review of an operating QMS — so weaknesses surface on your terms, not a regulator's.
Every QMS drifts from its own documentation over time — a procedure gets a workaround, a CAPA closes without addressing root cause, a change control skips a step under deadline pressure. None of it shows up until an inspector finds it.
I review operating quality systems the way an inspector would: reading procedures against records, interviewing the people who actually run them, and scoring the gap between what’s written and what’s practiced. The output is a risk-ranked report your leadership team can use to close the right gaps first — backed by 25 years managing these same systems from the inside across pharmaceutical, biopharmaceutical, and vaccine manufacturing.
How it works
- 1
Document & process walkthrough
Systematic review of the Quality Manual, SOPs, and records against current practice.
- 2
Process-owner interviews
Cross-check documented procedures against how the system actually runs on the floor.
- 3
Gap scoring
Score each gap against GMP, ICH Q10, and ISO 9001:2015 clauses, with severity ranking.
- 4
Findings report
A clear, prioritized report — not a raw checklist — that a leadership team can act on.
- 5
Remediation support
Optional hands-on support closing out the highest-risk findings first.
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)
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
CQV Documentation
Apex-level CQV governance through to execution — Master Plans, risk assessments, and URS-through-PQ protocols for facilities, utilities, equipment, and computerized systems.
- CQV Master Plan (CQVMP)
- System Level Impact Assessments (SLIA) and Quality Risk Assessments (QRA)
- URS, Design Qualification (DQ), FAT and SAT protocols
Let’s talk
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