Practical Guidelines to FDA’s 21 CFR Part 11 Compliance


Most companies tend to oversee Part 11 compliance from the FDA, which can result in future consequences. In definition, 21 CFR Part 11 is the FDA’s regulation governing electronic documentation and signatures’ authenticity. Introduced in 1997, the Part 11 compliance sketch outlined electronic records management in any medical device quality assurance system. Read on and learn how to become 21 CFR Part 11 compliant.

Applicability to The Individual Company

Some organizations and businesses remain unwilling to adopt Part 11 compliance as they think their operations are paper-based. Yet, they have computer shared files and have some accessible through their servers. When the document or records are uploaded into the server, the company must become Part 11 compliant. Intrinsically, if any log is readily available in the servers, then there is a need for acquiring the FDA’s 21 CFR Part 11 compliance certification.

Adhere to Part 11 Data and Security Protection Practices

All electronic documents and signatures are critical and can accompany severe repercussions when accessed by unauthorized people. The FDA, therefore, ensures all companies engaging in electronic operations have robust and different safety measures to data and passwords to protect such information. Besides, access to such information remains controlled and supervised.

Determining Clear-Cut Traceability Audits

Sometimes, having undesirable changes to the data without learning who did it can become problematic. Thus, it is crucial to incorporate clear audit trails to ensure effortless tracing of who deleted, deleted, made changes or caused data to become obsolete. Notably, all events, modifications, and activities of the data get recorded in real-time. This is because usernames, dates, and times of each authorized visitor, including what’s done, can be retrieved readily.

Following Laws Governing Electronic Signatures

Let it be biometric signature through fingerprints, digital signature, scanning, or handwriting software capture; Part 11 ensures quick reviews and approval of such data. Such signatures promote the provision of assigned usernames and passwords of all users, therefore guaranteeing transparency. Besides, any operations reviewed and approved permanently lock to avoid being edited, revised, or deleted by other users.

Avoid Outsource Responsibilities

Some software companies tend to promise to deliver Part 11 compliance solutions to different companies. Yet, it is the responsibility of the individual organization to manage and control electronic documentation and signatures. If any enterprise opts to outsource Part 11 compliance from third parties, it fails to become compliant and violates such regulations. 

Compliance Is A Continuous Process

When considering 21 CFR Part 11 compliance, it is essential to ensure the progressive handling of electronic documents and signatures throughout the project’s life cycle. Typically, this requires adequate capital and investment for the process to become effective. Some companies may also need to factor out some operations while altering the business plan when they prefer electronic documents and signatures.

From the above tips, several companies facilitate electronic documentation and electronic signature. DocuSign is Part 11 compliant while providing an electronic managed agreement suitable for different companies. The aforementioned are some of the critical elements to consider when looking to become FDA 21 CFR Part 11 compliance.