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.
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For validation, quality, and engineering teams in regulated life sciences.
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.
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.
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.
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.