If you work in the pharmaceutical or medical device industries, you’re probably familiar with FDA Part 11 compliance. This regulation governs digital processes and electronic records, and it’s a critical part of digital health for companies that supply these products. Part 11 compliance can be complicated, but understanding the basics is essential for ensuring that your company’s digital processes are up to snuff.
Basically, Part 11 requires that electronic records and signatures are consistent with traditional paper-based records. This means that digital signatures must be used whenever possible, and that all electronic records must be stored securely.
The regulation also lays out specific requirements for recordkeeping and auditing, to ensure that companies can track and verify all digital activity.
We’re here to help you understand 21 CFR Part 11 if you need it. While we are unable to provide official legal advice, we can provide you with a Certinal perspective on how the regulation works and what it means for your company.
In digital terms, a signature is an authentication technique used to ensure the identity of the person signing a document. In order for a digital signature to be valid, it must be unique to the signer and impossible to forge. The purpose of 21 CFR Part 11 is to establish requirements for electronic signatures that meet these criteria.
Digital Signatures Security : Steps to deploy your digital signature solution
This regulation applies to any electronic signatures that are submitted to the FDA, including those used in connection with pharmaceutical applications. By ensuring that digital signatures are valid and tamper-proof, Part 11 helps to protect the integrity of the FDA’s approvals process.
In general, the FDA will accept electronic signatures in place of traditional paper-based signatures if your organization follows all of the associated regulations and can confirm the authenticity of electronic signatures to an auditor.
It’s vital to note that ensuring your eSignatures are FDA-compliant can be a time-consuming process; Part 11 standards are significantly more complex than the ESIGN Act and UETA’s relatively easier and well-known criteria.
The first thing you should do is write a letter. You must tell the FDA of your intent in a “Letter of Non-Repudiation Agreement” before your company can collect signatures electronically. The letter should be prepared on corporate letterhead with a handwritten signature.
Once the documentation has been completed, a pharmaceutical company must follow the following:
Find out : Why you need Qualified eSignature
In some less-regulated industries, the type of eSignature that’s used isn’t imperative—and collecting them could be as simple as adding a signature field to an online form. Not so with the FDA. When submitting eSignatures to the FDA, you’ll need to prove your identity every time you sign by entering a username and password. The FDA requires this level of security for any digital signatures used in connection with pharmaceutical applications.
But what exactly is an digital signature, and how does it meet the FDA’s requirements? In general, digital signatures use advanced encryption techniques to verify the identity of the signer and ensure that the document hasn’t been tampered with. This makes them much more secure than traditional signatures, which can be less secure than standard eSignatures
In order to comply with regulations set forth by the FDA, it is essential to have a clear and concise policy in place regarding digital signatures. This policy should document both the procedures for using digital signatures as well as the workflows for ensuring each electronic record is authentic.
Additionally, it is important to note that any digital signature attached to an electronic record must remain connected to that record forever—the digital signature can never be removed, erased, or transferred.
Finally, the electronic record must include the printed name of the signer along with the date and time the document was signed. By following these guidelines, businesses can ensure they are compliant with all regulations regarding digital signatures.
Another requirement of CFR 21 Part 11 is that each electronic signature must have a comprehensive history. This audit trail should include a detailed history of all activities related to the document being signed, such as when it was prepared, how it was sent, how the signers’ identities were verified, and so on.
Those facts will assist protect you against accusations that someone didn’t see or sign the document in question, in addition to lowering your risk of noncompliance penalties.
The use of digital signatures is becoming increasingly commonplace in the pharmaceutical industry, as companies look for ways to streamline their operations and reduce costs. However, the transition to eSignatures brings with it a new set of compliance risks, as the FDA has specific requirements for the use of digital signatures in regulatory submissions.
As a result, it is essential to choose eSignature software that is specifically designed to meet FDA requirements. The software should maintain a full audit trail of all signature activities, and it should be able to generate tamper-proof signatures that can withstand legal scrutiny. By taking these precautions, you can help ensure that your organization remains compliant with FDA regulations.
Look for time stamps and other features that will automate the audit trail for you, as well as password protection and other advanced security capabilities, when choosing a vendor.