Computer system validation software for pharma and biotech, made simple with Matrix Validate
Matrix Validate is validation software for mid-size pharma and biotech teams. Trace every requirement to its risk and its test, run test scripts with evidence recorded as you go, and produce signed, inspection-ready documents without an enterprise rollout.
For taking a demo with our team.
The challenge
Validation that still runs on paper, PDFs and spreadsheets
- Testing is the bottleneckScripts are executed on paper or in a PDF tool and evidence is added afterwards, so contemporaneous, attributable records are hard to prove.
- Traceability by handURS, specs, risk assessments and test scripts live in separate files, and one change means checking every document again.
- Platforms built for someone elseEnterprise validation suites bundle equipment, process and shop floor execution that a CSV team running 20 systems does not need.
- Change control piles upEvery vendor release, patch and configuration change triggers an impact assessment and another round of regression testing.
- Inspections on the horizonAuditors expect signed protocols, executed scripts with evidence and a complete trace matrix, delivered on request.
- The rules are tighteningThe draft revision of EU GMP Annex 11 asks for owned system requirements, stricter audit trails and full re-authentication at signing.
The solution
Traceability-first validation for teams your size
Other tools digitise the protocol. Matrix Validate makes sure the protocol tests the right things, by keeping requirements, risks and tests as connected data rather than rows in a document.
- Requirements as dataURS, FS and DS are individual items with their own fields, history and approvals. Change one and every document that uses it updates.
- Risk drives test scopeA built-in risk assessment in line with GAMP 5 and ICH Q9(R1) links every control to the test that verifies it.
- Enforced traceabilityTrace rules flag any requirement without a test and any risk without a control, before an auditor does.
- Test execution with evidenceRun scripts step by step with pass or fail results, comments, screenshots and attachments recorded against each step.
- Signed, inspection-ready documentsGenerate plans, trace matrices and summary reports from live data, sign them with 21 CFR Part 11 compliant e-signatures and export them to your QMS.
- Reuse across systemsCopy a validated project, reuse test cases across your GxP systems and rerun them at every release instead of starting again.
Core validation capabilities
Everything a CSV team needs to plan, execute and report the validation of GxP computerised systems.
Computer system validation
Validate eQMS, LIMS, ERP and in-house applications through the GAMP 5 V-model, with CSA-style risk-based testing.
Learn moreEquipment qualification
Run URS, DQ, IQ, OQ and PQ for in-house equipment and test rigs, traced to the risks they address.
Learn moreEU GMP Annex 11 readiness
See what the draft revision changes for computerised systems and work through a six-step gap assessment.
Learn moreChange control and revalidation
Impact analysis flags every item downstream of a change, and redlining shows exactly what changed and what needs retesting.
AI that drafts, people approve
Built-in AI drafts test cases from your requirements and finds traceability gaps. Nothing is saved or approved without a human review.
Fits the stack you have
Works alongside your QMS and document system, with out of the box Jira, Azure DevOps and GitLab integrations, a REST API, and SaaS or on-premise hosting.
FAQ
01What is Matrix Validate?
Matrix Validate is computer system validation software from Matrix One for pharma and biotech teams. It manages user requirements, specifications, risk assessments, test scripts and executed test runs as connected items, and generates signed validation documents from that data. It runs on the same platform as Matrix Req, which large pharma and medical device companies already use for validation work.
02Who is Matrix Validate for?
Mid-size pharma, biotech and combination product companies, typically 100 to 3,000 people, whose CSV team validates configured or custom GxP systems (GAMP 5 categories 4 and 5) such as eQMS, LIMS, ERP and in-house applications.
03Does Matrix Validate support CSA as well as CSV?
Yes. You can take the risk-based approach set out in FDA's Computer Software Assurance guidance and GAMP 5 Second Edition: assess the risk of each requirement, scale the testing to match, and keep lighter documentation where the risk is low.
04Does Matrix Validate meet 21 CFR Part 11 and EU GMP Annex 11?
Matrix Validate provides the technical controls those rules expect: personal user accounts, version history on every item, and electronic signatures that require full credentials at the point of signing. Compliance also depends on your own procedures, so Matrix One supplies a pre-written validation package for the platform itself.
05Do we need to validate Matrix Validate itself?
Yes, as with any GxP system. Matrix Validate comes with a ready-made validation project: requirements, test cases, the plan and the report are pre-written, and your team reviews and executes them in the platform. Major releases are announced in advance with release notes and V&V reports, so revalidation is a rerun, not a rewrite.
06Can it replace our QMS or document management system?
It does not need to. Matrix Validate manages the validation lifecycle and exports signed PDFs, so validation documents can be filed in the QMS or document system you already use.
07What does Matrix Validate not cover yet?
Matrix Validate focuses on computer system validation and qualification of in-house equipment. Statistical process, cleaning and analytical method validation, and paperless execution on the shop floor, are not part of the current product.
08How is Matrix Validate priced?
Pricing depends on the number of users and the systems in scope. Book a demo and we will put together a proposal for your team.