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.
I’ve sat on both sides of the inspection table — supporting USFDA, WHO-Geneva, CDSCO, and ISO 13485 audits from inside the quality unit, and now helping sites prepare for them as an outside reviewer. That combination is what makes a mock audit useful: knowing what an inspector actually asks for, and how a real quality team is stretched trying to answer it live.
A gap analysis engagement is built to surface your findings on your schedule, not the regulator’s — classified by real risk, not documentation neatness, so your team spends its remaining time before inspection closing what actually matters.
How it works
- 1
Scope & standard selection
Agree the target regulatory standard and inspection scope — facility, product line, or full site.
- 2
Mock inspection
A structured walkthrough that mirrors how the real authority will inspect: documents, facility, and people.
- 3
Gap classification
Every observation classified by severity and mapped to the specific clause or expectation it fails.
- 4
CAPA planning
A realistic, owned CAPA plan — not just a findings list — with dates that hold up under follow-up.
- 5
Verification
A follow-up pass to confirm CAPAs actually closed before the real inspection date.
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
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
Ready to talk about gap analysis & audit readiness?
Share a little about your site and timeline — I'll follow up within one to two business days with next steps.