CSV/CSA
ClinTask deliver specialized software testing and validation solutions to ensure compliance with applicable regulatory guidance required by the US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and other international regulatory authorities.
- Assessment of critical needs
- Project specifications with company approval
- Traceability matrix.
- Maintenance of a validated state.
Our validation service deliverable includes
- Validation Plan
- User Requirements and Functional User Requirements and Functional
- Risk Assessment
- Requirements Trace Matrix
- Test Protocols
- Executed/documented test scripts
- Validation Summary Report