FDA 21 CFR Part 11 Compliance

Guidelines for FDA-governed Industries

What is FDA 21 CFR Part 11?

21 CFR Part 11 is the FDA guideline that defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to that of the paper records. Part 11, as it is commonly known, was introduced in 1997 and applies to FDA-governed industries that choose to store their primary, authoritative records electronically. It stipulates the guidelines and rules for storage, copying, access & permissions, audit logs & tracking. It also identifies version control of the electronic records and the application of electronic signatures to them.

Part 11 applies to all records that are defined in the underlying Acts and Regulations which govern activities in the life sciences industries. Part 11 requires drug makers, Medical Devices manufacturers, biotech companies, biologics developers, and other FDA-regulated industries to implement controls, including audits, system validations, audit trails, electronic signatures, & documentation for software and systems involved in processing electronic data that are either required to be maintained by the FDA predicate rules or used to demonstrate compliance to a predicate rule.

ComplianceQuest (CQ) supports 21 CFR Part 11 FDA compliance requirements for life sciences organizations in health-care, pharmaceutical, life-science, biotechnology, medical- manufacturing, medical devices, and other FDA-regulated industries. Title 21 CFR Part 11 requires companies to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems that are involved in processing many forms of data, as part of their business practices and product development.

Title 21 CFR Part 11 enacted the FDA’s requirement that they are able to recognize electronic records and electronic signatures as trustworthy, reliable, and legal equivalents to paper records and handwritten signatures. This also allows companies to adopt a ’paperless’ system of record keeping.

Electronic Signature

To remain compliant with 21 CFR Part 11, CQ automatically secures the authenticated user’s electronic signature while ensuring the user has signed onto the system and showcased their signature via the forced authentication process.

Audit Trail

Audit Trail is one of the most useful features from CQ. This tool can be used to store audit trail information, post all field changes automatically to a separate database, and query whenever needed. The Audit Trail includes various information, including the field’s old value, new value, and details related to the change.

What are the Different Parts of 21 CFR Part 11

21 CFR Part 11 is issued by the U.S. Food and Drug Administration (FDA). This part outlines the regulations for electronic records and electronic signatures. It applies to various industries, such as pharmaceuticals and healthcare. The various sections of 21 CFR Part 11 include:

Subpart A - General Provisions defines the scope and application of the regulations, including the types of records covered and the exemptions.
Subpart B - Electronic Records outlines the requirements for electronic records, including validation, audit trails, and access controls.
Subpart C - Electronic Signatures provides guidelines for electronic signatures, including the criteria for their acceptability and controls to prevent their unauthorized use.
Subpart D - Maintaining, Retaining, and Retrieving Records addresses the responsibilities of organizations in terms of record retention, retrieval, and availability for inspection by the FDA.
Subpart E - Use of Electronic Signatures in Electronic Records: delves deeper into electronic signatures and the controls required to ensure security.
Subpart F - Electronic Copies of Electronic Records discusses the requirements for creating and managing electronic copies of electronic records.
Subpart G - General Requirements covers general requirements for closed and open systems and systems not under the organization’s immediate control.

Compliance to FDA 21 CFR Part 11 Requirements

Requirements of 21 CFR Part 11

The FDA requires businesses to maintain all documents electronically. Businesses using a closed system to maintain records must comply with 21 CFR Part 11.10. Businesses using the closed system must employ procedures and controls designed to maintain electronic records’ authenticity, integrity, and confidentiality.

System validation to ensure data security and integrity of record keeping
Audit trail to trace the development of a process
Restricted access for better security control
All system users must have essential training to perform everyday tasks
Record generation with search and indexing functionality for easy recovery
Quality procedures that instill operational control over people and process within the development cycle
Digital signature across the organization for a quick and easy approval process

Benefits of FDA 21 CFR Part 11

Mandated by FDA, 21 CFR Part 11 offers a range of benefits. Some of them are:

Secure controls are mandatory. As a result, compliant systems are required to limit user access to prevent unauthorized system access.
Electronic signatures are legally binding and make the approval process easy.
Better audit trail, thus ensuring regulatory compliance and easy record maintenance.

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What are 21 CFR Part 11 Compliant Document Management Systems?

A 21 CFR Part 11 compliant Document Management System is a software solution that adheres to the regulations outlined in 21 CFR Part 11. These document management systems are designed to facilitate the creation, storage, retrieval, and management of electronic records and electronic signatures in a manner that complies with FDA requirements.

FDA 21 CFR part 11 Compliance Maintenance Checklist

Checklist for Maintenance of Electronic Records and Documents for FDA 21 CFR Part 11 Compliance

FDA 21 CFR Part 11 clearly outlines a set of requirements for maintaining electronic records and getting electronic signatures. For regulatory affairs (RA) teams, it is important to maintain an exhaustive checklist to ensure regulatory compliance, even as regulations keep evolving.

Over the years, Team CQ has helped RA teams around the world automate and streamline their compliance requirements. The following checklist is a good place to start:

Determine if the medical device comes under FDA 21 CFR Part 11 Compliance
Ensure your EQMS is compatible with FDA requirements
Make sure your EQMS system comes with an integrated document management system
Have an audit trail of all electronic records and signatures
Take care of data protection and privacy requirements
Submit regulatory documents on time
Ensure closed-loop traceability for all document changes
Make sure the EQMS software is installed properly and is capable of meeting all regulatory requirements