Complete Guide to 21 CFR Part 11 Compliance & Salesforce
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
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:
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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