Validated environments · GxP
Testing that stands up to an audit
In pharma and life sciences, a test only counts once it is approved, signed and traceable. We set up and run GxP-compliant testing – from risk-based validation to paperless execution with Tricentis Vera.
Computer system validation (CSV/CSA)
Risk-based validation strategy following GAMP 5 and FDA Computer Software Assurance: validation plan, risk assessment, traceability from URS to test evidence, validation summary report.
Digital validation with Tricentis Vera
Paperless review and approval with 21 CFR Part 11-compliant electronic signatures, record locking and a full audit trail – integrated with qTest, Tosca, Jira/Xray and SAP Cloud ALM / Solution Manager.
GxP test management
Thinqist as your testing SPOC: test planning, pre-execution approval, execution with evidence, deviation handling and sign-off. GxP and non-GxP projects in one toolchain.
Validated SAP S/4HANA & automation
Tosca automation for validated SAP landscapes, regression packs for change control and periodic review, and enablement of your internal testers.
From requirement to validation report
- URS
- Risk assessment
- Approved scripts
- Execution & e-signature
- Deviations
- Validation report
Standards we work to
What you get
- Validation plan and risk assessment
- Traceability from URS to test evidence
- Approved test scripts, executed with evidence and e-signatures
- Deviation handling and sign-off
- Validation summary report
Tools we use
Validating a GxP-relevant system?
Talk to us about validated testing