Validation

Our Client: A medical device company engaged Safis to validate an IVD (in-vitro diagnostic) assay.

Safis was engaged to validate the changes to the assay protocol software and the operating system. Safis Solutions provided the following services:

• Assisted with the creation of validation documentation and ensured that all aspects of the electronic data collection were 21 CFR Part 11 compliant
• Provided Software testing plan
• Wrote requirements documents
• Developed test cases
• Executed test cases
• Authored test summary report
• Assembled documentation used as part of the 510K submission