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AI-native validation

Validation documentation that drafts itself — and proves every line.

Generate SOP-governed validation deliverables, keep your requirements traceability live, and run paperless GxP test execution. AI drafts; your team reviews and approves — with a tamper-evident audit trail underneath it all.

What it does
01 · Generate

SOP-governed drafts

Produce URS, functional specs, risk assessments, protocols and summary reports from approved templates — every section cites the source it drew on, and gaps are flagged rather than invented.

02 · Trace

Live requirements traceability

Requirements link to risks, tests and evidence automatically. See coverage, orphans and gaps update as the project moves, and export the matrix in a click.

03 · Execute

Paperless GxP test execution

Run protocols on screen with electronic signatures and attached evidence, raise deviations inline, and auto-build the validation summary — all on one tamper-evident audit trail.

21 CFR Part 11 EU GMP Annex 11 ALCOA+ GAMP 5

Designed around the principles of these frameworks: AI proposes, qualified reviewers approve, and every action — generation, edit, signature, approval — is recorded on an append-only, hash-chained audit trail. Built to support your validation lifecycle, not to replace your quality judgement.