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Improve compliance with 21 cfr part 11 regulations and avoid fda citations and warning letters

21 CFR Part 11 specifies requirements for handling electronic records and electronic signatures and applies to any records covered by FDA regulations that exist in an electronic form. The main objective behind implementing this regulation was to prevent fraud while facilitating, promoting the possible use of electronic technology to reduce expenditures incurred from paper sources.

This articles written by SignupTraining’s expert panel provides an overview of FDA requirements for electronic systems and the applicability of 21 CFR Part 11. It also details consequences for non-compliance and six key aspects FDA regulated firms should focus on so as to ensure compliance.

What is 21 CFR Part 11?

21 CFR Part 11 regulates the use of electronic records and electronic signatures required by predicate rules governing manufacturing processes in FDA regulated industry. It mainly focuses on ensuring the authenticity, reliability, integrity of data in the form of electronic records and signatures. The regulation was implemented as an effort by the agency to set minimum compliance guidelines for computerized systems and minimize the possibility of data misappropriation.

The objectives of 21 CFR Part 11 can be listed as:

•       Validating systems to ensure accuracy, reliability

•       Enhancing ability to generate accurate and complete copies

•       Control and identification of records, system documentation

•       Preventing methods to falsify records

•       Accurate and ready retrieval of records

•       Limiting system access to authorized individuals

Applicability of 21 CFR Part 11

21 CFR Part 11 applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical products by firms which choose to use electronic records or signatures. The regulation applies to all records which exist in an electronic form even if they don’t have to be submitted to the FDA but have to be maintained in facilities.

These regulations do not mandate the use of electronic records and electronic signatures by firms. The rules also provide flexibility to determine customized methods of security to fulfil compliance requirements.

FDA regulated companies are expected to chart out a detailed implementation plan that suits their business goals and should be aware that the regulations apply to all electronic systems used.