CSV & GxP
Validation and compliance-oriented technical resources.
Support for computerized systems in regulated life-science environments.
CV
Computer System Validation
Resources for planning, testing, documentation and execution of validation activities.
GP
GAMP 5 & GxP
Consultants familiar with risk-based approaches and regulated computerized systems.
DI
Data Integrity
Support for controls, testing and documentation related to reliable and traceable data.
Potential resource profiles
CSV Consultant • Validation Engineer • QA IT Consultant • GxP Business Analyst • Test Lead • Validation Project Manager
21 CFR Part 11EU Annex 11GAMP 5Risk AssessmentTest Execution