Signature Logs

A colleague asks “In the era of digitalization and electronic signatures, do you believe in continuing to collect wet ink signature as part of employee training file? Can Part 11 electronic signature be used as an attestation that electronic signature is legally binding as handwritten signature?”

Great question. Collecting wet signatures is a real pain. Transitioning to digital practices can also significantly streamline our processes. It seems like a win-win. What could go wrong?

First, let’s ask “just how digital are you?”. It is essential to inventory your various practices and determine what is what. I think there are several categories here:

1. Starts as paper, retained as paper
2. It starts as paper and is retained as electronic. For example, you might print a form, fill it out, and route it through DocuSign or your eDMS for approval.
3. Starts as electronic, retained as paper
4. The entire lifecycle is electronic.

Most pharmaceutical companies are in a weird situation where we do a lot of work, starting on paper, scanning it, and then approving it. This is especially true at virtual companies, where a lot of the action happens at a CxO.

Do that inventory because you probably have more paper than you think—lots of paper. Plus, having an inventory will allow you to decide on future steps.

Before we get to the solution, let’s look at the regulatory requirements.

A is for Attributable (that’s good enough for me)

First Principle: Records should be signed and dated using a unique identifier attributable to the author. (PIC/S Data Integrity Guidance 8.6.1 Expectation 4.)

The guidance then goes on to say, “Check that there are signature and initials logs that are controlled and current and that demonstrate the use of unique examples, not just standardized printed letters.”

Second Principle: Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. (21CFR11.100(c))

To comply with 21 CFR 11.100(c), organizations must:

1. Prepare a Certification Letter: Draft a letter to the FDA certifying that the electronic signatures used in their system are legally binding.
2. Submit the Certification: Send the certification letter to the FDA.
3. Maintain Records: For future reference, keep a copy of the certification letter in the organization’s regulatory information management system (RIM) or quality management system (QMS) records.
4. Keep Individual Records: Everyone should affirm that the electronic signature used across systems is binding.
5. Be Prepared for Requests: Be ready to provide additional certification or testimony if the FDA requests. Like, say, an inspection.

This regulation ensures that electronic signatures are treated with the same level of trust and legal standing as traditional handwritten signatures, thereby supporting the integrity and reliability of electronic records in FDA-regulated industries.

Third Principle: The FDA lives within a constellation of other laws

Individual employees generally do not need to provide a wet signature attesting to the legally binding nature of an electronic signature. However, there are some important considerations:

1. Legal validity: Electronic signatures are legally binding in the United States under the ESIGN Act and UETA, provided certain conditions are met.
2. Intent and consent: Two critical elements for a legally binding electronic signature are:

• Intent to sign
• Consent to do business electronically

1. Best practices for employers:

• Implement a uniform policy on how employees sign agreements and onboarding documents.
• Consider using two-factor verification for electronic signatures to provide additional proof of authenticity.
• Ensure clear labeling of buttons and boxes for electronic signatures.
• Include a consent clause for electronic transactions.
• Provide an opt-out option for those unable to sign electronically.

While employees generally don’t need to provide a wet signature attesting to the legally binding nature of an electronic signature, employers should ensure their electronic signature process demonstrates intent and consent.

What to do

If your inventory showed everything is electronic, great. Get that attestation from the user as part of new hire orientation, and you are good to go. That attestation can be electronic. It just needs to be quickly retrievable in a way to answer an inspection.

If the inventory showed any paper, then yes, keep collecting those signature/initial logs.

Forms, forms, everywhere