SMB Validation

What do we need to satisfy 21 CFR Part 11?

21 CFR PART 11 details the regulatory requirement for electronic records, but how does it apply to your equipment and processes? Much of the confusion that surrounds the 21 CFR Part 11 regulations is caused by the various interpretations being applied to it and the specific purpose or function of the record. The SMB Group Inc. can determine a specific organization or site interpretation of the 21 CFR Part 11 regulations. We then collect data for specific equipment to evaluate the extent to which a software product is compliant with the FDA Electronic Records and Electronic Signature requirements as defined in 21CFR Part 11 and compare it against it’s intended use.

Contact us to discuss your requirement and learn more.