A History of Questions about FDA Rules
A cursory examination of online compliance forums indicates plenty of conflicting opinions and outright rumors about document signing. For instance, some people believe that blue pen is the only acceptable medium for document signing because it permits regulators to distinguish original signatures from printed replicas.
Other individuals, however, contest that blue isn’t allowed precisely because it fails to produce photocopies reliably. Similarly, firms wonder whether gel pens and water-soluble inks are appropriate and if their validation document submissions even require wet signatures.
Sound confusing? Fortunately, the FDA has released some specific guidelines about digital and hard-copy document signing. For instance, the FDA accepts scanned, digital and flattened digital signatures as being equally valid in some ways, but they may not all be equally appropriate in every situation.
In short, while your firm’s implementation of signing standards or adoption of specific ink colors aren’t likely to lead to rejections, but signatures that appear questionable or hard to verify can definitely cause trouble. What’s really important is how well your signatures support the assertion that your records are indeed what they seem.
Clarifying the Signature Issue
The FDA recommends that firms talk to FDA Center personnel to find out which kind of signature is appropriate before submitting a document. It’s also worth noting that different kinds of center-specific submissions are bound by individual preparation guidelines.
Signature rules may be uniquely affected by the nature of the submission in question. Just as with software validation, general guidelines don’t always pass muster when it comes to maintaining compliance.
Creating a Reliable Signature System
In addition to following the FDA’s basic rules about digital and wet signatures, many firms supplement their signing procedures with additional documentation. Even though the agency doesn’t typically check electronic or paper signatures without an identified need, for instance, GxP companies are advised to maintain security certificates and other verification information just in case they’re necessary during subsequent inspections.
The agency’s guidelines also detail how documents and submissions should be handled. 21 CFR Part 312, for instance, maintains that investigators are to retain records for two years after the approval or disapproval of drug marketing applications and makes note of the need for dated signatures on medical reports and drug trial consent forms.
Such third-party signatures may not necessarily mimic the same institutional signing standards you have in place within your organization, but standardizing them could make things a lot easier. Whether you’re choosing record-keeping software for your FDA Part 11 compliance efforts or simply working with a new partner, it’s wise to talk with a consultant who can tell you how you’ll need to modify your document signing procedures to ensure smooth submissions and less painful inspections.