21 CFR Part 11 | FDA Computer Software Assurance

21 CFR Part 11 | FDA Computer Software Assurance

Title 21 of the Code of Federal Regulations (21 CFR) is a section of the United States Code of Federal Regulations that covers various aspects of food and drugs. Part 11 of Title 21 CFR specifically addresses electronic records and electronic signatures in the context of the U.S. Food and Drug Administration (FDA). This regulation is commonly referred to as "21 CFR Part 11."

Here's an overview of 21 CFR Part 11 and its relevance to computer software assurance:

21 CFR Part 11 Overview:

1. Scope:

   - Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth by FDA regulations.

   - It also applies to electronic signatures used in connection with such records.

2. Applicability:

   - Part 11 is applicable to pharmaceutical, biotechnology, and medical device companies, as well as other FDA-regulated industries.

3. Objectives:

   - The primary objectives of Part 11 are to ensure the authenticity, integrity, and confidentiality of electronic records and signatures.

   - It provides criteria for the acceptance of electronic signatures as equivalent to traditional handwritten signatures.

4. Requirements:

   - Part 11 outlines specific requirements for the use of electronic records and signatures, including validation, audit trails, electronic copies, and system security.

Computer Software Assurance:

1. Validation of Software:

   - Part 11 requires that computer systems used to generate electronic records and signatures be validated.

   - This involves ensuring that the software functions as intended and meets the requirements for its intended use.

2. Audit Trails:

   - Systems subject to Part 11 must have secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions.

3. Security Measures:

   - Adequate controls must be in place to prevent unauthorized access to the system and to limit system access to authorized individuals.

4. Data Integrity:

   - Part 11 emphasizes the importance of data integrity, requiring that electronic records accurately reflect the data entered and that the records are complete and unaltered.

5. Electronic Signatures:

   - Electronic signatures must be unique to the individual, secure, and ensure that the signer cannot repudiate the signed record as not genuine.

Compliance Challenges and Solutions:

1. Documentation:

   - Companies need to maintain comprehensive documentation of their software validation processes.

2. Risk Management:

   - Implementing riskmanagement strategies to identify and address potential risks to data integrity and system security.

3. Training:

   - Providing adequate training for personnel on the proper use of electronic systems and adherence to Part 11 requirements.

4. Periodic Reviews:

   - Regularly reviewing and updating systems to ensure continued compliance with changing regulations and technological advancements.

Overall, compliance with 21 CFRPart 11 is crucial for companies in FDA-regulated industries that use computer systems to manage electronic records. Non-compliance can lead to regulatory actions and may impact product approvals and market access. It's essential for organizations to stay informed about updates to regulations and to implement robust computer software assurance measures to ensure compliance.

Citations:

Polarion ALM Software | How to ease FDA 21 CFR Part 11 Compliance? (complianceg.com)

FDA 21 CFR Part 11 Compliance | Trends | Innovations | Best Practices (complianceg.com)

21 CFR Part 11 Compliance | Must-have features of QMS (complianceg.com)