FDA Part 11 Compliance and Validation

[lensler1]

We would like to find a consultant that has been through the task of making a Validation plan and executing it successfully, That is, validating the functionality of Windchill function by function and then using the audit trail to varify that the task was completed by Windchill. etc. This effort would directly lead to a Part 11 validation Compliance.

We would like to find someone who already has a validation plan that we could use, buy, or hire to validate our system.

Larry Ensler

Optovue, Inc.

Fremont CA

[mespinosa]

Larry,
The owner of my consulting firm, and I completed an FDA Part 11 Compliance and Validation for a non-medical device company last year. Please contact Chris Perren of Round Rock Software (cperren@roundrocksoftware.com), or myself to discuss this work effort. We would be happy to assist you on this effort.
We performed the project planning, creation of the test case scenarios, the execution of the test, creation of the test results, tracing of the test failures and defects and the creation of the test summary reports.

Best Regards,
Mike Espinosa
<u>http://www.roundrocksoftware.com/</u>