Let Validation Labs handle the documentation part of your MoCRA compliance journey.
Your best engineer starts writing an IQ protocol on Monday. By Friday, they've touched it three times—between a mixer breakdown, a supplier call, and two production emergencies.
Every interruption means 20+ minutes to get back into the document. After a production crisis, they're starting from scratch mentally—and it shows in the writing.
Page 3 written Tuesday doesn't match page 7 written two weeks later. The acceptance criteria don't align with the test methods. FDA sees right through it.
What should take a focused week stretches across two months. Meanwhile, the equipment is running unqualified and your compliance gap grows wider.
The fix: Send us your raw data—specs, parameters, test results. We produce cohesive, inspection-ready documents while your engineers stay focused on what they do best.
When your staff writes documentation between production calls and equipment alarms, you get protocols written in 15-minute fragments over six weeks. The result? Documents that contradict themselves, skip critical steps, and fall apart under FDA scrutiny. There's a better way.
Equipment specs, process parameters, cleaning agents, test results—whatever you've got. Messy is fine.
Our team distills your information into clear, compliant protocols, SOPs, and validation packages.
Review, approve, and file. When FDA shows up, you've got everything they're looking for.
Everything you need to pass an FDA inspection—nothing you don't. Documentation that's actually proportionate to your operation.
Clear, practical SOPs for production, cleaning, batch records, and QC. Written for real operators to follow—not to impress auditors with page count.
IQ/OQ/PQ protocols that prove your equipment is installed correctly and performs consistently. From mixers to fillers to packaging lines.
Preventive maintenance schedules and calibration procedures. Keep your equipment running right with tracking tools and certificate templates.
Scientifically sound programs proving your equipment is free from residue and contaminants. From experiment design through final protocol execution.
The best compliance program is one your team will actually follow. We build documentation that's practical, proportionate, and designed for real manufacturing floors—not binder shelves.
— Our philosophy at Validation Labs
Let's start with a free assessment. No pressure, no 50-page proposals—just a clear picture of what you need.