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How to Ensure Signature Compliance with FDA Regulations

April 27, 2023

As we discussed in an earlier post, the humble signature has become more complicated — and more regulated — with the advent of digital and electronic technologies. Here’s a quick recap of the three types of signatures as they’re defined today:

“Wet” signatures are what we used to call, well, “signatures” — signing a physical piece of paper with an ink pen.
Electronic signatures or e-signatures are transmitted electronically, and are often created with a stylus on a digital pad. Although they’re increasingly accepted as replacements for wet signatures, the level of security they provide — and the legality of their use — can vary considerably.
Digital signatures are electronic signatures with significantly more robust security. Most often, a third-party Certificate Authority (CA) uses a cryptographic hash algorithm to verify your identity. They’re essentially the digital equivalent of a notarized signature.

Understanding these three classifications is critical to signature compliance in the pharmaceutical industry.

FDA CFR Part 11

The FDA’s 21 CFR Part 11 provides foundational guidance for electronic records and signatures in the pharmaceutical industry.

Part 11 is based on the basic prerequisite that systems must be validated according to GMP. (It’s also relevant for GDP, GLP, GCP, and medical devices.)

Pharma companies that choose to maintain electronic records or to submit certain types of information to the FDA electronically are subject to Part 11, which applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations.

Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act and the Public Health Service (PHS) Act.

FDA Signature Options

Although the FDA does not require digital signatures, it does require all of the following when signatures are provided in electronic form:

The printed name of the signer
The date and time the signature was executed
A unique user ID
The “digital adopted signature”, which can be any one of the following:
- The signer’s name and initials reproduced in an electronic “font”
- The signer’s name and initials signed on a digital device (e.g. using a stylus or finger on a smartphone or tablet, signing with a mouse on a desktop computer, etc.)
- A scanned version of a “wet” signature
The meaning of the signature (known as the “signing reason”)

addition, electronic signatures that are not based on biometrics must comply with the following additional regulations:

At least two distinct identification components, such as an identification code and a password, must be employed.
Electronic signatures must be used only by their genuine owners.
Non-biometric signatures must be administered and executed to ensure that attempted use of an individual’s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.

Signature Options in LabVantage 8.8

Both electronic and digital signature options are available in LabVantage 8.8, allowing labs to use whichever is needed to ensure compliance with global regulations.

LabVantage has supported electronic signatures for many years, using an electronic record that specifically indicates a signature as defined by 21 CFR 11 and the EU’s similar Annex 11 regulations.

LabVantage has 2 fields, “Action” and “Reason”, that accompany the electronic signature. The Action is supplied by the LabVantage software (such as review, approval, responsibility, or authorship), but the user can also enter a Reason. Together these provide the “meaning” associated with the signature as required by 21 CFR 11.

A digital signature option was added to reports in LabVantage 8.8, which is cryptographic and requires a digital certificate that is generated and validated by a 3rd party. Although this is not required by the FDA, it’s very useful for meeting other signature requirements, particularly in Germany and other EU countries that now have digital signature standards.

Sign Up for Full LIMS eSignature Capabilities

The ability to handle both electronic and digital signatures is paramount to ensuring security and authenticity, especially in highly regulated environments like the pharma industry. LabVantage is the only LIMS that currently offers both options.