21 CFR Part 11 Compliance: What You Need to Know

Introduction:

If you work in a regulated industry that uses electronic records and electronic signatures, such as pharmaceuticals, biologics, medical devices, etc., you may have heard of 21 CFR Part 11. This is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). The regulation was issued by the FDA in 1997 to ensure the trustworthiness, reliability, and equivalence of electronic records and signatures to paper ones. The regulation aims to prevent fraud, errors, and data loss in the creation, modification, maintenance, archiving, retrieval, and transmission of electronic records and signatures that are subject to FDA oversight.

In this article, we will provide an overview of the key requirements and best practices of 21 CFR Part 11 compliance.

Key Requirements of 21 CFR Part 11:

The regulation consists of three subparts: A (General Provisions), B (Electronic Records), and C (Electronic Signatures). Subpart A defines the scope and application of the regulation, as well as some key terms and definitions. Subpart B specifies the controls and requirements for electronic records, such as validation, audit trail, security, copies, and retention. Subpart C specifies the controls and requirements for electronic signatures, such as components, identification codes, passwords, and manifestations.

The key requirements of 21 CFR Part 11:

• Computerized System and software validation: The systems and software used to create, store, and maintain electronic records must be validated to ensure that they are reliable and meet the requirements of 21 CFR Part 11.

• Access controls: Access to electronic records must be controlled to ensure that only authorized personnel can access them. Appropriate segregation of duties must be ensured.

• Audit Trail: There must be an audit trail to capture all changes of GxP data.

• Change controls: Any changes made to electronic records must be controlled to ensure that the integrity of the records is maintained.

• Electronic signatures: Electronic signatures must be used to sign electronic records in a way that is equivalent to handwritten signatures.

• Record retention: Electronic records must be retained for a period of time that is consistent with the requirements of 21 CFR Part 11.

• Backup and Restoration: Appropriate backup and restoration must be ensured.

The purpose of these requirements is to ensure that electronic records and electronic signatures are just as trustworthy and reliable as paper records and handwritten signatures. These requirements are designed to ensure data integrity, security, and reliability in electronic records and signatures.

Best Practices to maintain Electronic Records and Electronic Signatures:

To achieve compliance with 21 CFR Part 11, it is important to conduct a risk-based assessment of the system and its intended use. The system refers to the combination of hardware, software, controls, and documentation that are used to create, modify, maintain, archive, retrieve, or transmit electronic records and signatures. The assessment should identify the potential risks and hazards associated with the system and its use, as well as the appropriate controls and procedures to mitigate them.

Best practices to maintain electronic records and electronic signatures (ERES):

• Establish a strong governance framework. This should include a clear understanding of the regulatory requirements, as well as the development and implementation of appropriate policies and procedures.

• Use a qualified electronic signature solution. This should be a solution that has been validated and meets the requirements of 21 CFR Part 11.

• Implement strong security controls. This includes protecting the confidentiality, integrity, and availability of ERES.

• Train staff on the use of ERES. This should include training on the regulatory requirements, as well as the specific procedures and controls that are in place.

• Conduct regular audits and reviews. This will help to ensure that ERES are being maintained in a compliant manner.

Conclusion:

Complying with 21 CFR Part 11 can increase efficiency and productivity, improve data security and integrity, reduce risk of errors and fraud, and improve compliance with regulatory requirements. If you are a pharmaceutical company or medical device manufacturer, you should carefully consider 21 CFR Part 11 compliance. By implementing the necessary controls, you can help to ensure that your electronic records are trustworthy and reliable, and that you are in compliance with FDA regulations.

Reference:

?US FDA 21 CFR Part 11