FDA compliant signatures — what is 21 CFR Part 11 compliance?

A woman uses her computer to research 21 CFR part 11 compliance.

Learn about part 11 of Title 21 CFR and how it changes electronic record and signature regulations on government documents.

When it comes to electronic signatures, what is 21 CFR Part 11 compliance? Think of 21 CFR Part 11 as a set of digital rules issued by the US Food and Drug Administration (FDA) that go beyond the medical and pharmaceutical industries. These regulations are all about ensuring the safety, authenticity, and reliability of electronic records and signatures.

Let’s explore what 21 CFR Part 11 compliance means, why it matters beyond the healthcare field, and what it involves for anyone dealing with electronic signatures and data security.

What is 21 CFR Part 11?

The Code of Federal Regulations (CFR) are rules that the executive departments of the US Federal Government must follow. Title 21 contains all regulations that apply to the Food and Drug Administration (FDA), while Part 11 pertains to criteria that make electronic signatures and documents trustworthy for use in the federal government.

Essentially, all electronic documents or signatures used by the FDA must follow the rules covered in Title 21 CFR Part 11. If electronic government documents adhere to all regulations under Part 11, they become the equivalent of paper records.

What industries have to be 21 CFR Part 11 compliant?

The FDA oversees highly technical and complicated industries that require immense amounts of paperwork. Any time a corporation needs to implement controls, request an audit, or document new systems, they must submit paperwork to the FDA.

Title 21 CFR Part 11 brings FDA regulations into the digital age by allowing electronic documents and signatures on official government business. This affects industries regulated by the FDA, including:

Drug manufacturers

Medical device producers

Biotech

Biological developers

The use of digital signatures and electronic documents helps to speed up processes and simplify the approval of new products.

FDA electronic signature requirements for 21 CFR Part 11 compliance.

In highly regulated industries such as pharmaceuticals and healthcare, the US Food and Drug Administration (FDA) has established comprehensive guidelines under 21 CFR Part 11. These guidelines are aimed at ensuring that electronic signatures are as reliable and secure as traditional handwritten ones. To achieve compliance, you must meet some specific requirements that include:

Unique user identification. Assign a unique identifier to each electronic signer.

Password controls. Enforce strong password policies, including regular updates.

Audit trails. Maintain comprehensive records of all electronic signature actions.

Secure signature storage. Safeguard signatures against unauthorized access.

Record retention. Preserve electronically signed records securely and unalterably.

User authentication. Authenticate user identities before granting electronic signature privileges.

Maintaining electronic audit trails. Have an electronic signature audit trail and keep a comprehensive record of all electronic signature activities to track and verify every action.

Use tools to stay 21 CFR Part 11 compliant.

To be accepted under 21 CFR Part 11, a digital document and e-signature must be secure, trustworthy, and reliable. If you want to make sure you have legally binding electronic signatures, use trusted software like Adobe Acrobat Sign to legally sign digital documents with the click of a button and move along government processes.

Discover what more you can do to simplify the approval of digital government documents without sacrificing their security, including creating secure e-signatures.