The Typical Steps in a Validation Project are:

• Validation Planning - The decision is made to Validate the System. A System Owner is identified and validation resources are gathered.


• Requirement Gathering - System Requirements are identified. Requirements are collecting into appropriate Specifications and approved.


• System Testing - Testing Protocols are written and approved and the System is tested to ensure that it meets all requirements.


• System Release - The Summary Report is written and System is release to the End Users for use.


• Change Control - If changes need to be made after validation is complete, Change Control should be used to ensure that the system change does not affect the system in unexpected ways.

General Validation Issues

• Validation Terminology
• Frequently Asked Questions about Validation
• Testing Deviations
• Change Control for Validated Systems

Requirements and Design Specifications

• User Requirement Specification
• Functional Requirements
• Design Specification

Test Plans / Test Protocols

• Testing Protocols
• Installation Qualification
• Operational Qualification
• Performance Qualification

Additional Validation Documents

• Validation Plans
• Traceability Matrix
• Risk Assessment
• Summary Report

• Computer System Validation
• Training courses on computer validation