This article highlights 21 CFR part 11, its scope, applicability and effective ways to maintain regulatory compliance.
Table of Contents
21 CFR Part 11 is a regulation introduced by the United States Food and Drug Administration (FDA) that sets forth the criteria under which electronic records and electronic signatures (ERES) are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
It is significant in regulatory compliance within the healthcare and life sciences industries because it helps to ensure the integrity and reliability of Electronic Records and Electronic Signature (ERES).
This is important because electronic records are increasingly being used in these industries to manage critical data in clinical trials manufacturing and quality control.
What is 21 CFR Part 11
21 CFR Part 11 was established in 1997 to ensure that electronic records and signatures are just as reliable and trustworthy as paper records and handwritten signatures.
The regulation has helped to improve the quality and efficiency of record-keeping processes in these industries. It has also helped to reduce the risk of fraud and other forms of data corruption.
The regulation applies to all ERES created, modified, maintained, archived, retrieved, and/or transmitted under any records requirement set forth by the FDA.
Itcovers a wide range of topics, including:
- System security
Electronic systems must be designed and implemented to protect ERES from unauthorized access, modification, or destruction. - Audit trails
Electronic systems must create and maintain audit trails that record all activities related to ERES, such as creation, modification, and deletion. - Electronic signatures
Electronic signatures must be unique to each individual and must be able to be linked to the individual who signed the record. - Access controls
Electronic systems must have access controls in place to restrict access to ERES to authorized individuals.
Parts and Structure of 21 CFR
21 CFR is divided into following parts each of which covers a different aspect of regulation:-
Subpart A: General Provisions
It lays the foundation by defining key terms and concepts that are crucial for understanding the regulation and includes:-
- Scope and Applicability: Subpart A defines the scope of Part 11, explaining which organizations and activities are subject to compliance.
- Definitions: It provides clear definitions for terms like “electronic record,” “electronic signature,” and “closed system.”
- Background and Purpose: Subpart A offers insights into why 21 CFR Part 11 was established, emphasizing the need for reliable and secure electronic records and signatures in FDA-regulated industries.
Subpart B: Electronic Records
It specific requirements for:-
- Controls for Closed Systems: Subpart B discusses the importance of controls in ensuring the integrity and security of electronic records. It emphasizes the need for user access controls, audit trails, and accurate record retention.
- Signature Manifestations: This section addresses how electronic signatures should be linked to electronic records and how they should appear when viewed
Subpart C: Electronic Signatures
It complements Subpart B by focusing on the requirements and procedures for electronic signatures. Key elements of Subpart C include:
- Electronic Signature Components: It defines the components required for electronic signatures and how they should be generated.
- Controls for Identification Codes and Passwords: Subpart C outlines the controls necessary to maintain the security and confidentiality of identification codes and passwords used for electronic signatures.
Subpart D: Controls for Closed Systems
It provides an overview of the general principles and requirements for ERES as per USFDA. It focuses on:-
- Record Authenticity: Subpart D stresses the importance of maintaining electronic records in a manner that ensures their authenticity, reliability, and trustworthiness.
- Record Protection: It discusses safeguards to protect electronic records from unauthorized access, alteration, or deletion.
Subpart E: Controls for Open Systems
It builds upon the requirements introduced in Subpart C by offering further details on the components and controls necessary for electronic signatures.Key aspects of Subpart E include:
- Biometric Signatures: It addresses the use of biometric technology for electronic signatures and the associated controls to ensure their reliability.
- Use of Secure Cryptographic Methods: Subpart E encourages the use of secure cryptographic methods to enhance the security of electronic signatures.
Applicability and Compliance Requirements
Organizations that are subject to 21 CFR Part 11 must comply with all of the requirements of the regulation.
This includes implementing appropriate system security controls, creating and maintaining audit trails, implementing electronic signatures, and training employees on the proper use of electronic systems and the procedures for complying with 21 CFR Part 11.
21 CFR Part 11 is applicable to records related to the development, manufacture, testing, and quality control of regulated products, such as drugs, medical devices, and food.
It is covered under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (the PHS Act)
Ways to Stay Compliant with 21 CFR Part 11
Compliance with 21 CFR Part 11 is not an option; it’s a necessity. Here are ten essential tips to help organizations navigate the complexities of Part 11 and stay compliant:
- Establish a Compliance Team
Designate a team responsible for overseeing and ensuring compliance with Part 11. Clearly define roles and responsibilities within the team. - Implement Document Control Procedures
Develop and enforce robust document control procedures that include version control and access control for electronic records. - Validate Computer Systems
Ensure that all computer systems used for generating, maintaining, and storing electronic records are validated and meet Part 11 requirements. - Secure Electronic Signatures
Implement secure electronic signature processes, including identity verification and robust password policies. - Maintain Audit Trails
Regularly review and monitor audit trails to detect any unauthorized changes or access to electronic records. - Ensure Data Integrity and Protection
Implement data backup and encryption measures to protect the integrity and confidentiality of electronic records. - Conduct Regular Training and Awareness Programs
Provide ongoing training and awareness programs to educate staff on compliance requirements and updates. - Perform Periodic Compliance Audits
Conduct internal and external audits to identify and rectify compliance gaps. - Develop Electronic Records Retention Policies
Establish clear policies for the retention and disposal of electronic records to meet regulatory requirements. - Stay Informed about Regulatory Changes
Continuously monitor regulatory updates and adapt your compliance strategies to remain current and aligned with evolving regulations.
In conclusion, complying with 21 CFR Part 11 ensures the reliability and security of electronic records and signatures, safeguarding data integrity, patient safety, and regulatory adherence. Failure to uphold this compliance could lead to severe consequences.
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