Overview of Validation Documents and Projects
Validation is the documented process of demonstrating that a system or process meets a defined set of requirements. There are a common set of validation documents used to provide this evidence. A validation project usually follows this process:
- Validation Planning – The decision is made to validate the system. A project lead is identified, and validation resources are gathered.
- Requirement Gathering – System Requirements are identified. Requirements are documented in the appropriate specifications. Specification documents are reviewed and approved.
- System Testing – Testing Protocols are written, reviewed, and approved. The protocol is executed to document that the system meets all requirements.
- System Release – The Summary Report is written and system is released to the end-users for use.
- Change Control – If changes need to be made after validation is complete, Change Control ensures that the system changes does not affect the system in unexpected ways.
General Validation Issues
Validation Documents: Requirements and Design Specifications
Validation Documents: Test Plans/Test Protocols
Additional Validation Document Resources