Overview of Validation Documents and Projects
Ofni Systems is the industry leader in 21 CFR 11 Compliance
Validation Projects, Consultation, Assessments and Training
Typical Steps in a Validation Project are:
- 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
Requirements and Design Specifications
Test Plans / Test Protocols
Additional Validation Document Resources