How ready is your facility, really?
A 28-point GMP readiness self-assessment covering the six areas investigators probe first — documentation, qualification, quality systems, data integrity, suppliers, and cleaning. Mapped to 21 CFR Part 111, Part 117, Part 507, and MoCRA where they apply. Work through it in about 20 minutes and see exactly where your evidence is thin.
Six sections. Zero fluff.
Every check is a yes/no question tied to a real requirement — the same questions we ask in week one of a readiness assessment.
Documentation & batch records
5 checks — master records, batch documentation, specifications, lab records, retention. Mapped to 21 CFR Part 111 / 117.
Facility & equipment qualification
5 checks — IQ/OQ/PQ coverage, calibration, environmental controls, segregation, water systems.
Quality systems & CAPA
5 checks — quality program ownership, deviation investigations, CAPA closure, complaint files, management review.
Data integrity & Part 11
5 checks — system validation, audit trails, access control, e-signatures, backup and restore testing.
Supplier control
4 checks — identity testing, supplier qualification, COA verification, rejected-material handling. Mapped to Part 111 / 117 / 507.
Cleaning validation
4 checks — validated cleaning procedures, residue limits, changeover control, cleaning records.
Get the checklist.
Enter your work email and we’ll send the PDF right away — plus one follow-up with an offer to walk through your results on a free call. No spam, ever.
Rather talk it through with a human?
Start with a free GMP readiness call — we’ll walk through your top 3 GMP risks and give you an honest fit assessment. Confidential, no pressure.