ChatGMP
Pharma + GMP knowledge management AI. Ask any GMP, USP, ICH, 21 CFR, or EudraLex question and get a sourced answer with audit-ready citations. Built for QA managers, regulatory affairs, and inspectors who need to be right and need to prove it.
What ChatGMP Knows
- ✓ 21 CFR Parts 11, 210, 211, 314, 600, 820 — full text + interpretive guidance
- ✓ EudraLex Volume 4 (EU GMP) — all chapters and annexes including the new Annex 1 (sterile manufacturing) and Annex 11 (computerised systems)
- ✓ ICH Q-series (Q1A through Q14) — quality, stability, validation, lifecycle
- ✓ USP general chapters — <61>, <62>, <71>, <232>, <233>, <711>, <905>, <1058>, <1078>, <1225>, more
- ✓ WHO GMP, PIC/S, Health Canada NHPR, Japanese GMP, Brazilian RDC
- ✓ FDA warning letters and 483s, parsed and indexed for precedent search
Why It's Different
Sourced answers, always
Every response cites the exact regulation, USP chapter, or guidance document — with the section number and a copy of the source text.
Audit-ready output
Every interaction is logged with timestamp, query, response, and citations. Export the chat as an audit-trail PDF.
Decision-grade by design
Built on QGI's replayable / signable / defensible framework. Same query + same regulatory snapshot = same answer.
No hallucinated regulations
ChatGMP refuses to answer when the regulatory text doesn't support a definitive interpretation. Flags ambiguity instead of inventing certainty.
Use Cases
- · "What does USP <1058> require for analytical instrument qualification of an HPLC?"
- · "Show me FDA 483 observations for data integrity in microbiology labs from the last 3 years."
- · "Compare 21 CFR Part 11 §11.10(e) vs EU Annex 11 §9 on audit-trail retention."
- · "Draft a deviation investigation outline for an OOS result on assay during stability."
Reserve early access
ChatGMP launches in 1 week. Reserve your seat now — we'll onboard the first 50 reservations directly.
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