Use of Electronic Signature in Pharmaceutical Industry for Higher Compliance

electronic signature in pharmaceutical industry

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 your company’s digital processes are up to speed.  Part 11 requires electronic records and signatures to be consistent with traditional paper-based documents. Electronic signature in pharmaceutical industry must be used whenever possible, and all electronic records must be stored securely. 

The regulation also outlines 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 needed. While we cannot provide official legal advice, we can provide you with a Certinal perspective on how the regulation works and what it means for your company. 

Understanding FDA part 11 (21 CFR part 11) 

In digital terms, a signature is an authentication technique used to ensure the identity of the person signing a document. For a electronic signature in pharmaceutical industry to be valid, it must be unique to the signer and impossible to forge. 21 CFR Part 11 aims 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 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. 

Generally, the FDA will accept digital signatures for pharma instead 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. 

electronic signature in pharmaceutical industry

Interpreting FDA part 11 for businesses 

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. 

Find out: Why you need Qualified eSignature 

To include an electronic signature in pharmaceutical industry, a company must follow the following

1. Identity verification as a part of signature acquisition 

In some less-regulated industries, the type of electronic signature in pharmaceutical industry 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 must prove your identity every time you sign by entering a username and password. The FDA requires this level of security for any digital signatures connected with pharmaceutical applications. 

But what exactly is a 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 

2. Establishing critical workflows 

In order to comply with regulations, set forth by the FDA, it is essential to have a clear and concise policy regarding digital signatures. This policy should document both the procedures for using digital signatures and the workflows for ensuring each electronic record is authentic. 

Additionally, it is essential 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 signer’s printed name along with the date and time the document was signed. By following these guidelines, businesses can ensure they comply with all digital signature regulations. 

3. Robust audit trail for non – repudiation 

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 signed document, such as when it was prepared, how it was sent, how the signers’ identities were verified, and so on. 

Those facts will assist in protecting you against accusations that someone didn’t see or sign the document in question, in addition to lowering your risk of noncompliance penalties. 

How to choose the right solution for pharmaceutical organizations 

  • Is there a minimum of 256-bit encryption and several identity verification techniques in the e-signature to protect sensitive information such as demographic data, medical history, test results, and insurance information? 
  • Is it compatible with various verification techniques, including digital ID verification, email, SMS authentication, one-time access codes, and phone calls? 
  • Is there a way to centrally administer e-signatures across all departments and organizations so that you can keep control of document security settings? 
  • Is it possible to track e-signature activity via the web, mobile, and API, detect potential dangers using rule-based alerts and respond fast with decisive measures using advanced analytics? 
  • Does this e-signature system come with features like organization management, document access management, audit certifications, and monitoring tools? 
  • Does this provider comply with industry regulations such as HIPAA and 21 CFR Part 11, allowing you to conduct clinical trials in your hospitals? 

Also read: Pricing Strategies of Electronic Signatures 

Conclusion

The use of electronic signatures in pharmaceutical industry is becoming a common sight as companies look for ways to streamline their operations and reduce costs. However, the transition to eSignatures brings a new set of compliance risks, as the FDA has specific requirements for using digital signatures in regulatory submissions. 

As a result, it is essential to choose eSignature software specifically designed to meet FDA requirements.

The software should maintain a complete 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. 

When choosing a vendor, 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. 

If you have any further questions or want more information about how Certinal could benefit your organization, please do not hesitate to book a demo with us. 

Recommended Reads

author avatar
Author
Aritra is an experienced marketing professional with over five years of expertise in various industries. He specializes in brand management, campaign design, demand generation, marketing process optimization, and PR. Aritra holds a master’s degree from Bennett University, and he has actively contributed to several student initiatives during his time there.
Table of Contents

Categories

Related Resources

Recommended Resources

Certinal - IDC

Slash your Enterprise eSign & Web Form Costs by 50%!

Certinal's Enterprise-Grade Security & Compliance