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How To Address Electronic Signature Compliance


Compliance is a top concern for businesses across industries, including healthcare, medical device, laboratories, and more. To stay compliant, organizations need to make sure multiple aspects of their operations are following regulations set forth by the U.S. government. Any technology used, tools implemented, and data stored are all elements of a business that are tightly regulated depending on the business's industry. Healthcare organizations, for example, are obliged to follow the Health Insurance Portability and Accountability Act (HIPAA), which aims to ensure that data privacy is guaranteed, and medical information is securely stored. Electronic signatures are an important component of staying compliant as businesses move paper to the digital realm.

What is Title 21 CFR Part 11?

The U.S. Food and Drug Administration (FDA) established Title 21 CFR Part 11 as the regulation on electronic signatures. The law defines how electronic signatures are considered reliable and equivalent to paper records, and it applies across industries, including biotech, pharmaceutical, medical device manufacturing, and more. The 21 CFR Part 11 title requires companies that use electronic signatures to prove that the electronic documents are authentic. For businesses that process large volumes of digital paperwork, this requirement can prove to complicate operations.

Many businesses can apply 21 CFR Part 11 because any instance of a business scanning and putting paper documentation into a digital network counts as an electronic record in Part 11. The law aims to ensure that electronic signatures are as real as paper ones. Remaining compliant with Part 11 is the responsibility of the business using electronic documents. This is where document management software comes in.

If your business has regulatory requirements to follow, one of the tools that can help you process compliant electronic signatures is FDA-compliant document management software. This provides quality control software solutions that help you comply with various regulations in your industry.

How Does Document Management Software Help You Stay Compliant with Electronic Signatures?

Document control is essential to stay compliant with Part 11. Document management software (DMS) provides several crucial benefits, including:

  • Retaining required signatures indefinitely
  • Collecting and storing required sign-offs automatically
  • Storing documentation for retrieval at any time, including current and previous versions of documents and signatures
  • Storing all major revisions throughout a document's life cycle

Digital signatures require using a digital certificate – an electronic key that demonstrates the authenticity of a digital instance and its information. Document management software helps securely store and manage documentation that requires these signatures and provides a full audit trail on all documents within the system.  This means that a report can be pulled showing all actions taken on a given document, when, and by whom.

Document management software also automates many manual paper processes to help:

  • Ensure protection of records
  • Guarantee system access is only provided to authorized individuals
  • Implement the creation of audit trail documentation
  • Validate systems to ensure accurate, reliable performance

DMS can also help guarantee that people who develop, maintain, and provide electronic signatures are knowledgeable about how to remain compliant through electronic training and comprehension tests.

Stay Compliant with ENSUR

DocXellent has been providing companies in many regulated industries with a document control application that offers all the necessary controls and safeguards since 1983. We help businesses with not only 21 CFR Part 11 compliance, but 21 CFR Part 820 and a dozen other standards and regulations. Our ENSUR document management software can be implemented on-premise for ultimate control over your document management processes, or it can be accessed through a robust, secure, and proven cloud-based installation. In either environment, your electronic signatures remain compliant with 21 CFR Part 11 and any other regulations you need to conform with so your business can rest assured of its compliance with these complicated laws.

Tags: FDA Compliant Document Control Software, FDA Electronic Signature, Electronic Signature, Digital signature, 21 CFR compliance