Q: I’m contacting you to get advice on a possible issue regarding electronic signatures encountered during an audit of one of our contract manufacturers.
The contract manufacturer in question manufactures and releases implantable medical devices for our company. We hold the product registration with FDA, and the manufacturer is registered with FDA as a Contract Manufacturer.
This manufacturer uses electronic records and electronic signatures for its product release records. According to the training I received from EduQuest on Part 11 compliance, organizations using electronic signatures as the legally binding equivalent to handwritten signatures are required to send a written certification to the FDA.
So here’s my question: does the certification requirement apply to both product registration holders and their registered contract manufacturers? Does FDA expect to receive a certification from registered contract manufacturers who use electronic records and signatures? Or is the Part 11 certification requirement only for product registration holders?
A: Because the company manufacturing the finished device is a contract manufacturer and is not owned or a part of your company — and because it is using electronic signatures to comply with FDA regulations — the contract manufacturer must file a certification statement with FDA to be in compliance.
Generally, anyone required to register with FDA should file a certification with FDA if they use electronic signatures for FDA compliance. This webpage provides additional details from FDA about its expectations (and the process) for electronic signature certification.
Answered by Martin Browning, the President and Co-Founder of EduQuest, who was the co-author of the original 21 CFR Part 11 regulation during his 22-year career at the FDA.
Martin also is the developer and co-instructor of EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 training class..