Systems Qualification
InPharMetrics Ltd. can provide support and guidance in the three main sections of validation and qualification; Installation Qualification, Operation Qualification and Performance Qualification. The responsibilities for these steps will be shared by the client, InPharMetrics and the vendor. Support and assistance with system qualification includes the following activities;
- Generation of : Validation Strategy, Validation Master Plan, User Requirement Specifications, System Design Specifications, Requirement Traceability Matrices, Validation Summary Report
- Generation and review of Test Scripts
- Vendor IOQ Pre and Post-Approval