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.

The challenge
Our solution

Core capabilities

System validation support designed for life sciences and medical device regulatory requirements.

Validation documentationValidation 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 executionTest 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-signaturesFull 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 traceabilityLink 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

Roche

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

Matrix One is trusted by 500+ Life Sciences & Medical Device Companies