The MEPSCo GAMP Roadmap
22 document types. 8 steps. One process refined across 96+ equipment procurement and validation projects in medical device manufacturing.
This is the roadmap Reza built from scratch at Gen-Probe in 2001 — starting from a FAT with no documentation and working backwards to map every step a manufacturer needs to take before equipment arrives, during the build, through validation, and into production. It’s been tested on every project since.
Download it. See the full process. If it lines up with what your team needs, book a Manufacturing Automation Assessment and we’ll talk through your specific project.
The GAMP & Process Management flowchart, plus an overview of working with MEPSCo. Two pages, PDF, 1.1 MB.
Download the GAMP Roadmap (PDF)What’s in the Roadmap
The complete equipment procurement lifecycle, in sequence.
Customer Interview and Presentation
How stakeholder requirements get surfaced before anything is written.
Customer Requirements Document
Proof of Principle, Proof of Concept, Budgetary URS, Budgetary Quotes — the documents that produce a real number for management before procurement begins.
User Requirements Specification
Quotes, vendor analysis, project timeline and management, trace matrix — the documents that define what the vendor builds against.
Functional Requirements Specification
Machine failure mode analysis — requirements translated into functional design terms.
Design Requirements Specification
Design review, punch list and summary — the vendor’s design checked against the requirements before fabrication begins.
Factory Acceptance Testing
Test method and document development, FAT punch list — every requirement verified at the vendor’s facility before the equipment ships.
Equipment Delivery and Installation
The transition from vendor facility to manufacturer site.
Site Acceptance Testing
Test method and document development, SAT punch list — every requirement verified in the manufacturer’s environment after installation.
Qualification and Validation
PFMEA, engineering studies, validation plan, IQ, OQ, PQ — the documentation that releases the equipment to manufacturing.
Release to Manufacturer
Operator SOP, PM SOP, incoming material specification — what the internal team needs to run and maintain the equipment after the engagement ends.
Who This Is For
Download the roadmap if you are:
Named references at Hologic, Philips Medisize, and Kinematic Automation.
What Happens After You Download
The roadmap gives you the full picture of the process. If you want to talk through how it applies to your specific project — what scope makes sense, what documentation you already have, what’s missing — the Manufacturing Automation Assessment is the next step.
Book a Manufacturing Automation Assessment