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GxP Copilot

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GxP Copilot produces the validation or qualification package for a computerised system, analytical instrument or piece of equipment in GxP-regulated life sciences. It classifies the asset from confirmed facts (a GAMP 5 category for software, a USP \<1058\> group for an instrument, an EU GMP Annex 15 criticality for equipment) and drafts the full deliverable set from one intake: validation plan, requirements, risk assessment, IQ/OQ/PQ protocols and a live requirements traceability matrix. The AI drafts; qualified people review, decide and sign under 21 CFR Part 11 and EU Annex 11. Classification, risk scoring and release verdicts are computed deterministically, so the same inputs always give the same answer.

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