Providing documented evidence that a process creates and manages data which supports your quality decisions with the highest degree of assurance of meeting the predefined characteristics is considered validation for computerised systems. While putting intended use as the predominant factor in a validation exercise, pi Life Sciences supports its partners with the appropriate risk-based validation approach leading to computerised system assurance.
Our expertise in CSV & Data integrity entails:
- Validation strategy, planning and management
- Risk and impact assessments
- Specification and validation of process automation and monitoring Compliance with computer systems, electronic records and signatures
- Qualification of laboratory equipment and software validation (GAMP 5, USP 1058)
- Excel-spreadsheet-validation (GAMP 5)
- Assessment of Electronic Records Electronic Signatures (ERES) of Production and Laboratory Systems
