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Matrix Validate

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Matrix Validate is computer system validation (CSV and CSA) software for mid-size pharma and biotech teams. It is traceability-first validation: user requirements, risks and tests live as structured, linked data, so every protocol tests the right things and gaps show up before an inspector finds them. Teams use Matrix Validate to: Write URS and functional specifications as structured requirements, with configurable item types and enforced trace rules. Assess risk in line with ICH Q9 and GAMP 5, and trace every risk to the tests that cover it. Draft test steps with built-in AI test generation, then review and approve them. AI drafts, people sign. Execute test scripts with contemporaneous evidence, and reuse test cases across systems and releases. Generate 21 CFR Part 11 compliant live documents and traceability matrices, ready for audits and inspections. Connect to Jira, Azure DevOps and GitLab out of the box. Matrix Validate is built for CSV teams validating configured and custom GxP systems (GAMP 5 categories 4 and 5) and helps them prepare for the revised EU GMP Annex 11. It is available as SaaS or on premise, runs on the proven Matrix Req engine, and is delivered by Matrix One, an ISO 13485 and ISO 27001 certified company.

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