Validation in Matrix Quality
Built-in validation modules so you do not need to treat system validation as a separate project. Validation documents are prepared by the system, and test scripts are executed electronically.
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The challenge
System validation in regulated environments is a project in itself — without the right tools
- Validation is treated as an afterthoughtMany organisations spend weeks manually writing validation plans, test scripts, and reports as a separate workstream — often after the system is already in use.
- Paper-based test execution is error-proneManual test scripts completed on paper introduce transcription errors and create gaps in your validation evidence.
- Electronic signature compliance is complexMeeting FDA 21 CFR Part 11 and EU Annex 11 requirements for electronic records and signatures requires specific system capabilities.
Our solution
Validation built into the system — documentation prepared, test scripts executed electronically
- Validation documents prepared by the systemMatrix Quality generates validation plans, test scripts, and reports aligned to your validation strategy — so your team is not starting from a blank page.
- Electronic test script executionTest scripts are executed directly within the system. Results are captured electronically, with user attribution and timestamps on every step.
- Full 21 CFR Part 11 and EU Annex 11 complianceElectronic records, electronic signatures, and audit trails are built into the platform — not bolt-ons.
Core capabilities
System validation support designed for life sciences and medical device regulatory requirements.
Validation documentation
Validation plans, test scripts, and summary reports are prepared by the system based on your validation scope and risk assessment. No blank-page authoring required.
Auto-generated validation plans
Pre-structured test script templates
Validation summary reports with full traceability
Electronic test execution
Test scripts are executed directly in the system. Pass, fail, or deviation results are captured electronically with user identity, timestamp, and any deviation notes.
Electronic test step execution
Pass/fail/deviation capture per step
User attribution and timestamp on every result
Electronic records and e-signatures
Full compliance with FDA 21 CFR Part 11 and EU Annex 11 for electronic records and electronic signatures — across validation and all system activities.
21 CFR Part 11 compliant e-signatures
EU Annex 11 aligned audit trails
Tamper-evident electronic records
Validation traceability
Link validation activities to the system requirements they test, giving you a complete validation traceability matrix ready for regulatory review.
Requirements to test script traceability
Validation traceability matrix
Ready for FDA and Notified Body review
Hear from our customers
Matrix Quality gives us a single, validated system for our entire quality process. Audits that used to take weeks of preparation now take days.
Quality Director, Life Sciences Company
