About Computer System Validation
Computer system validation (CSV) is the documented process of assuring that a computer system does exactly what it is designed to do in a consistent and reproducible manner. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.
Roles and responsibilities of Validation Engineer in Computer System Validation
Provide documentation during various stages of Software Development Life Cycle such as
- Supplier Selection
- Validation Plan
- Requirements Specification (User Requirements Specification, Functional Requirements Specification, Design Specification).
- Hardware Design
- Construction or Coding
- Design Review
- Risk Assessment
- Software Testing: Validation and Verification (Developer Testing and User Site Testing)
- Data Migration
- Requirements Traceability Matrix (RTM)
- Validation Summary Report
- Maintenance and Software Changes
- Software Validation Plan Revision
- Anomaly Evaluation
- Problem Identification and Resolution Tracking
- Proposed Change Assessment
- Task Iteration
- Documentation Updating
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