GAMP Documentation Services for Medical Device Manufacturers
GAMP documentation is not paperwork. It’s the process that determines whether your equipment gets validated on time, whether your vendor delivers what you actually specified, and whether your quality team can stand behind the documentation when FDA shows up.
When the documentation is wrong, or missing, none of those things happen on schedule. Change orders start. Timelines compress. The quality team asks questions nobody can answer. Management wants to know why the project is over budget.
The documentation isn’t the last step. It’s the foundation everything else is built on.
MEPSCo is sometimes called a GAMP consultant. It’s an accurate label as far as it goes — we consult on GAMP compliance for a living. The distinction worth knowing is what backs the label: a proprietary 8-step process and 22 document types tested across 96+ projects, not a framework learned from a certification course.
Where Most Manufacturers Go Wrong
There are three common approaches to GAMP documentation in medical device manufacturing. Two of them reliably produce problems.
Ask the vendor to handle it
Vendors build equipment. GAMP documentation isn’t their core competency, it’s a service they offer because customers ask for it, usually managed by someone who isn’t dedicated to documentation as a primary function. Validation typically happens six or more months after machine delivery. By then, the person who understood the build may be long gone.
Assign it to a junior engineer
Junior engineers can be trained to fill out documents. What they can’t substitute for is the pattern recognition that comes from 96+ projects, knowing which requirements get missed in a URS, which vendor claims don’t hold up during FAT, which validation steps create 483 exposure if not documented correctly.
Bring in a dedicated GAMP process
22 document types. An 8-step process modeled after FDA guidelines. Developed from scratch starting in 2001 at Gen-Probe, tested on every project since, refined across 96+ equipment procurement and validation engagements. This is what MEPSCo provides.
The 8-Step GAMP Process
Every MEPSCo engagement runs through the same process. The scope of each engagement determines how many steps are included. The process itself doesn’t change.
The 22 Document Types
MEPSCo’s documentation process covers 22 document types developed across 96+ projects. Not borrowed from another industry. Not adapted from a generic framework. Built from real project failures starting with the first FAT at Gen-Probe in 2001, when Reza was handed a machine with no documentation and had to figure out what the process should look like from first principles.
Every document type exists because a project showed what happens without it.
Download the GAMP RoadmapWho This Is For
MEPSCo’s GAMP documentation services are built for medical device manufacturers who need:
Device-as-a-product companies in FDA-regulated manufacturing environments. Diagnostics and IVD manufacturers. CDMOs operating under FDA scrutiny from both their clients and the agency.
The GAMP documentation process has been tested under real FDA scrutiny across 96+ projects over 25 years.
$150M in equipment documented and validated in one year during COVID-19 for a DOD pandemic contract. No change orders.
“Reza has been a driving force behind numerous high-value automation projects, both on-site and at our contract manufacturer facilities, over the past 15 years. His proficiency in executing FAT, SAT, Engineering Studies, IQ, OQ, and PQ has ensured that our systems meet and exceed regulatory standards, including FDA and GHTF process validation guidance.”
FRANK MAJDI · DIRECTOR, QUALITY ENGINEERING, HOLOGIC
“He is well versed in all aspects of automated projects from mechanical to electrical design, assembly/fabrication methods, and testing. Reza has mastered this guidance through the development of protocols from the URS through PQ that state the requirements and test them throughout the duration of the project to ensure project success.”
JERRY TER LAAN · PRESIDENT, JERIT AUTOMATION
Explore the Process in Detail
URS Development
The document that defines what equipment must do before any vendor builds it.
READ MORE →FAT / SAT Services
The last checkpoint before equipment leaves the vendor’s control.
READ MORE →IQ / OQ / PQ Qualification
Installation, operational and performance qualification, traced from the URS.
READ MORE →Fractional Automation Engineer
The engagement model behind every MEPSCo project.
READ MORE →Equipment Procurement & Vendor Management
Kepner-Tregoe vendor scoring and management through the build.
READ MORE →Download the GAMP Roadmap
All 22 document types, in sequence, as a single reference.
GET THE PDF →Common Questions
What is GAMP documentation?
GAMP (Good Automated Manufacturing Practice) documentation is the set of specifications, test protocols, qualification records, and transfer documents that govern how automated manufacturing equipment is procured, built, tested, and validated in an FDA-regulated environment. It covers the full lifecycle from the first requirements document through installation, operational, and performance qualification. Without it, manufacturers can’t demonstrate to FDA that their equipment was validated correctly.
How many document types does MEPSCo’s GAMP process cover?
22 document types covering every step from the Customer Requirements Document through release to manufacturer. Every document type was developed from a real project need, not adapted from a generic framework. The full list is detailed in the GAMP Roadmap, available for download.
What is the difference between GAMP 4 and GAMP 5?
GAMP 4 prescribed a rigid validation approach based on software category. GAMP 5 shifted to a risk-based approach, validation effort is proportional to patient risk, not software category. GAMP 5 is the current standard. MEPSCo’s documentation process is built around GAMP 5 principles and aligned with FDA 21 CFR Part 820 requirements for medical device manufacturers.
Does MEPSCo provide the full GAMP documentation package or individual documents?
Both. A full MEPSCo engagement covers the complete 8-step process from CRD through release to manufacturer. For manufacturers who have a project already underway and need specific documentation support, a URS, a trace matrix, an IQ/OQ/PQ package, MEPSCo can step in at any point in the process.
How does GAMP documentation prevent change orders?
Change orders happen when a requirement wasn’t defined upfront. A vendor quotes against a vague or incomplete URS, builds what they think the manufacturer wants, and issues change orders when the manufacturer asks for something different. A properly written URS defines every requirement specifically and verifiably. The vendor builds against it. FAT tests against it. There’s no ambiguity to exploit. That’s how 96+ projects produced minimal or no change orders.
Can MEPSCo provide GAMP documentation for equipment that was already procured?
Yes. One of MEPSCo’s case studies covers exactly this situation, a piece of off-the-shelf industrial filling equipment purchased without GAMP documentation that had to be retrofitted and validated. It’s harder, more expensive, and takes longer than doing it correctly from the start. But it can be done. A Manufacturing Automation Assessment is the right starting point to evaluate what documentation exists and what needs to be created.
Is a GAMP consultant the same as MEPSCo’s GAMP documentation process?
The title fits, but it doesn’t tell you what’s behind it. Anyone can call themselves a GAMP consultant. What matters is whether that consultant brings a proven, repeatable process. MEPSCo’s process covers 22 document types, tested across 96+ projects, not assembled fresh for each engagement.
Ready to scope your automation project?
30 minutes with Reza. Bring your project. Walk away with a clear picture of what GAMP documentation your project needs and what the engagement would look like.
Book a Manufacturing Automation Assessment