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What information should be included in the verification and validation documentation?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

The terms “verification” and “validation” described earlier in this document refer to two phases of Software Device testing. This section recommends the type of testing documentation you should include in a premarket submission for a Software Device, based on the Level of Concern.

Minor Level of Concern Devices

For Minor Level of Concern devices, FDA recommends that you submit documentation of system or device level testing, and, where appropriate, integration testing. The documentation submitted should include system or device level test pass/fail criteria and a summary of the test results.

Moderate Level of Concern Devices

For Moderate Level of Concern devices, FDA recommends that you submit a summary list of validation and verification activities and the results of these activities. It is also recommended that you submit your pass/fail criteria. You should ensure that the Traceability Analysis effectively links these activities and results to your design requirements and specifications.

Major Level of Concern Devices

For Major Level of Concern devices, FDA recommends that you submit the information recommended above for Moderate Level of Concern devices and a description of any tests that were not passed. It is also recommended that you include any modifications made in response to failed tests and documentation of results demonstrating that the modifications were effective. Documentation provided in your submission should include examples of unit integration testing and a summary of the results.

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