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Validation plan:
The FDA does not tell you how to validate your computerized system, but insists that you tell them how you
intend to validate it. We have created a simple step by step plan/template for you to meet this requirement.
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Risk management plan:
This is created to clarify potentional risks, determine the level of risk, and create response plans to mitigate
these risks. Within the validation package, we have included a sample risk management analysis and plan.
Validation report:
This document will explain how you followed your validation plan and what the end results were.
FDA software validation is extremely time consuming and can be very confusing, but it does not have to be.
By using our comprehensive FDA Validation Toolkit, you will have a simple guide with multiple templates
which include everything you need to complete your FDA validation. If your organization has limited experience with validation projects or you need more assistance beyond this Tool Kit, please call us and we can
provide qualified third-party consultants who will be happy to assist you.