GVL eVFDs Are Part 11 Compliant
Recently the FDA Center for Veterinary Medicine issued responses to VFD questions gathered during Farm Foundation workshops. This is a valuable resource for the industry as Jan. 1, 2017 approaches and many questions remain.
With these clarifications, we also want to help you understand how GlobalVetLINK (GVL®) FeedLINK eVFD system fits in with the FDA’s guidelines. Our goal is to make compliance as simple as possible.
The FDA says that an electronic VFD (eVFD) may be used instead of a paper VFD, as long as it meets the requirements of 21 CFR part 11. So what does that mean for vets, producers and feed distributors? Below are some key points to keep in mind.
Electronic VFD Formats
- Vets: A scanned copy of a paper VFD does not constitute an original electronic VFD. In that case, the original, ink-signed paper copy of the VFD is what must be stored by the veterinarian. FeedLINK powered by GVL SmartEngine technology creates and stores true electronic VFDs using a secure cloud-based system. This system has been scrutinized by a third party auditor who specializes in Part 11 compliance.
- Feed distributors and producers only need to save a copy of the VFD from the veterinarian. A scanned copy of the paper VFD is acceptable for this. Or, FeedLINK allows access to eVFDs in a secure, online account.
- An eVFD must be signed by the veterinarian, which can be done with a Part 11 compliant digital signature. GlobalVetLINK’s digital signatures are Part 11 compliant. When a vet signs the GVL eVFD, they must provide their username and password. Once the document is signed, it is locked from any further alteration. GVL utilizes PKI (Public Key Infrastructure) technology to digitally sign eVFD documents which enables those who view GVL certificates and VFDs to verify the certificate as an authentic electronically signed document.
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