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.
A Quality Management System is only as strong as the architecture underneath it. I design QMS frameworks that connect the Quality Manual to the Site Master File, and the Site Master File to every SOP, BMR, and BPR beneath it — so nothing is left as an orphaned document waiting to be found by an auditor.
This is ground-up work: for a new facility, a new product line, or an organization formalizing quality for the first time. Having built and operated these systems from inside manufacturing — not only advised on them from outside — I design for what holds up under daily production pressure and periodic regulatory inspection, not just what looks complete in a binder.
How it works
- 1
Current-state assessment
Review existing practices, facility scope, and the applicable regulatory pathway to define the target QMS.
- 2
System architecture & document hierarchy
Design the Tier I–III document structure and map every required procedure to it.
- 3
Procedure authoring
Write and cross-reference SOPs, forms, and records so they operate as one coherent system, not isolated documents.
- 4
Roll-out & training
Train process owners and staff, and pressure-test procedures against real operating scenarios.
- 5
Audit & management review cadence
Establish the internal audit schedule and management review rhythm that keeps the system alive after handover.
Related services
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
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 qms design & implementation?
Share a little about your site and timeline — I'll follow up within one to two business days with next steps.