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Overview of Validation Documents and Projects

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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.

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