Aptuit’s Informatics professionals provide a wide range of validation support activities, some of which draw on our comprehensive validation package containing the entire battery of tests and trace matrices used during the development and release of Clinicopia® itself.
While Clinicopia® is considered a ‘PQ Ready’ system out-of-the-box, all GXP clinical chain systems must undergo some form of testing and validation at the client’s site prior to deployment. Aptuit have a team of dedicated professionals providing a wealth of validation support and advice, fully compliant with the GAMP V recommendations to access this expertise from the software suppliers.
Aptuit validation services include:
- Validation Approach and Methodology Development
- Mapping the User Requirements Specification to Clinicopia®
- Consultation on Best Use of the Validation Package
- Custom Test Script Development
- On-site Assistance in Test Script Execution