1. Participates in the Computer Validation activities within a project or multiple projects.
2. Responsible for creating, managing, and/or maintaining the documents required for the development and validation of the computerized system.
a) May be responsible to create and review specific validation documents, as required, in the project.
- Authors Validation Plan, Training Plan, Issues Log, Design Review, IQ
- Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases,
- Test Incidents, Trace Matrix, and Validation report.
- Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description and Training records.
b) Contributes to CSV metrics for reporting purposes.
3. Prepares documentation within a validation package per policy and procedure to support the validation of an application/system.
4. Works at the direction of a Validation Lead within a project.
5. May participate in Protocol execution activities.
6. Participates in CSV effectiveness and improvement initiatives.
7. Participates in CSV knowledge development.
8. Create and execute validation test scripts and document test results in accordance with standards.
9. Review and evaluate validation assessments for application systems/projects