CFR 21: Everything You Need to Know About the FDA Regulation

In this article, we will explore the essence of the CFR Title 21 Part 11 and highlight the points all industries should consider concerning FDA regulations.

To establish a crucial regulatory framework ensuring the integrity of the supply chain in the food and pharmaceutical industries and to protect the health and safety of consumers, the FDA has developed 21 CFR Part 11.

What is 21 CFR Part 11?

It represents FDA (Food & Drug Administration) regulations, ensuring quality and traceability in food and medicines production. This set of regulations establishes essential standards to guarantee that electronic records and signatures of the manufacturing process are reliable and secure, legally equating them to paper records and handwritten signatures, preventing hindrances in tracking manufacturing stages.

Main points you should know:

Secure Electronic Records and Signatures

21 CFR Part 11 requires that electronic records be secure, unalterable, and easily retrievable. In addition, electronic signatures must be linked to specific individuals, ensuring accountability and traceability throughout the data's lifecycle.

Rigorous Validation Requirements

The regulation emphasizes the importance of proper validation of computer systems. The conduction of rigorous validation processes demonstrates that these systems consistently function and produce accurate results.

Comprehensive Audit Trails

21 CFR Part 11 requires computer systems to maintain comprehensive audit trails, capturing significant events such as data changes and access attempts.

Data Integrity

The regulation underscores the importance of safeguarding data integrity in electronic records. The application of data integrity controls, such as encryption and access restrictions, is essential to prevent unauthorized modifications or data loss.

Strong Access Controls

Ensuring that only authorized personnel have access to electronic records includes using unique user identifiers, strong password controls, and proper user privilege management.

Electronic Signature Requirements

Unique, secure, and verifiable electronic signatures are crucial in regulatory compliance.

In a world of advanced technology and constantly evolving regulations, compliance with 21 CFR Part 11 ensures that our computer systems maintain data integrity, generate reliable electronic records, and pass the test of current regulations. In line with this regulation, which has already become mandatory in certain countries, PAT Group has integrated the necessary software into its equipment to ensure compliance with these requirements.

We specialize in industrial efficiency solutions that meet each customer's specific needs. Our mission is to transform technological challenges into valuable opportunities through comprehensive solutions.

Do not hesitate to contact us for advice on this and other innovative proposals.