Complete Guide to 21 CFR Part 11 Compliance & Salesforce

Alice M.

Hawk-eye editor with a passion for trailblazing Salesforce experiences

Updated: Jan 9th, 2025

Welcome, if you are reading this article then chances are you are working with electronic and digital signatures in your business.

Want to know more about how to be fully compliant? Well, you have come to the right place!

In this short guide, we discuss the difference between e-signatures and digital signatures, explain Title 21 CFR Part 11, expand on this regulation’s requirements, and speak about 21 CFR Part 11 and Salesforce integration. Keep reading to find out more!

What is Title 21 CFR Part 11?

Title 21 CFR Part 11 is a FDA (Food and Drug Administration) regulation and it details the criteria that e-records and signatures must meet to prove they are as reliable as paper records. It can of course be confusing staying compliant, so we recommend using a trusted third party to help you out. Here at Titan, we use Global Sign for 21 CFR Part 11 validation, and they provide reputable signing certificates.

It is important to mention that 21 CFR Part 11 differentiates between electronic signatures and digital signatures. Digital signatures are understood to work with cryptographic technology to verify the identity of the signer. On the other hand, electronic signatures refer to e-signatures that are legally binding and equivalent to a handwritten signature.

21 CFR Part 11 Compliance Checklist

Now that we have an idea of what 21 CFR Part 11 checklist is, let’s check out the requirements. There are of course many clauses but here we will explain the general ones.

21 CFR Part 11 Requirements

Each e-signature needs to belong to a single individual and the same electronic signature can’t be used by multiple parties.

Any organization, like Global Sign, which issues a signing certificate, needs to first verify the identity of the signer.

It needs to be confirmed that the signer understands these signatures are legally binding and this should be proven via a certification.

People working with verified e-signatures need to have additional evidence ready that their electronic signature is legitimate.

If your 21 CFR Part 11 electronic signatures do not use biometrics then you need to use 2FA.

Only the true owners of the e-signatures can use them.

It should be ensured that it is impossible for a single person (without working in a coordinated team) to “hack” the signature or use it falsely.

The same should apply to biometrically controlled e-signatures, these should only be usable by the one true owner.

There are also lots more 21 CFR Part 11 regulations, which you can read on this Global Sign page. As we mentioned above, ensuring that you meet FDA requirements can be exhausting so we would suggest getting help from Global Sign.

Benefits of 21 CFR Part 11 Compliant Software

There are loads of benefits to staying compliant with this regulation. This includes ensuring the accuracy and integrity of your software’s data and resting easy that your records are secure. What’s more, if you work in an FDA-regulated industry then this is a must if you want to instill trust in customers and partners. Of course, using electronic signatures nukes the need for messy paperwork and saves you money when you lose the paper trail.

Here at Titan, we are big believers in staying compliant with all regulatory authorities so that we can provide top-tier security and give our customers peace of mind. If you were wondering whether or not to become compliant with 21 CFR Part 11, then this is your sign!

Salesforce Integration and 21 CFR Part 11

So now we are clued up on 21 CFR Part 11, where does Salesforce fit into the picture? Well, first up it’s important to note that while Salesforce has many capabilities to help you stay compliant, the responsibility for being so rests with you! Salesforce provides audit trails, validation, and several data integrity standards to help you out in this journey. Unfortunately, Salesforce does not offer its own signing solution, so what are your options?

Well, your best bet is to choose from one of the many tools on the AppExchange to do the heavy lifting for you. And ideally, you should go with a solution that provides you with Salesforce integrated signing combined with 21 CFR Part 11 compliance. Titan Sign is one of these solutions and we offer you:

Global Sign certified 21 CFR Part 11 compliance.

The ability to work with dynamic templates, documents, and signers.

The capability to identify your signers, using the power of Salesforce, in real-time.

Digital and Electronic Signatures, depending on the demands of your use case.

2FA and facial recognition for signers.

In addition to adhering to 21 CFR Part 11, we are also HIPAA compliant.

The ability to track the entire signing process in Salesforce.

Save your documents in Salesforce!

No matter your vertical market or use case, we are here to ensure you can track the entire signing process from end-to-end, reliably identify your signers, and stay compliant with all leading regulations.

Why not reach out today?

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Disclaimer: The comparisons listed in this article are based on information provided by the companies online and online reviews from users. If you found a mistake, please contact us.