compligen.AI is the company behind cGen, the AI-native Smart GxP platform for FDA, EMA, and MHRA-regulated life sciences companies. cGen digitalises the full computer system validation lifecycle — validation, compliance, and continuous monitoring — replacing spreadsheets, Word protocols, and bolt-on eQMS modules with one inspection-ready environment.

The cGen AI Assistant drafts user requirements, IQ/OQ/PQ test scripts, risk assessments, and gap analyses against 21 CFR Part 11, EU Annex 11, and GAMP 5 — while qualified humans review, approve, and sign every record with Part 11-compliant electronic signatures and a full audit trail. AI drafts; humans sign.

compligen.AI was founded by Michael J. Gregor, a CSV/CSA leader with 37+ years in FDA regulatory compliance and data integrity across 27+ life sciences organizations including Pfizer, Sanofi, Abbott, and Takeda, and a contributor to the FDA's Computer Software Assurance guidance process.

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