21 CFR Part 11 Compliance

Overview
The FDA introduced 21 CFR Part 11regulations to promote wide usage of electronic technology in the life sciences industry in a way that is compatible with FDA's responsibility to protect public health.Title 21 CFR Part 11 of the The regulations specifically deals with the FDA guidelines on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries to implement controls, including audits, validation systems, and documentation for software and systems involved in processing many forms of data as part of business operations and product development. It applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations and to electronic records submitted to the FDA.

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MetricStream solutions support 21 CFR Part 11 compliance for electronic records and signatures, including unique passwords for electronic signatures, password expiration and reusability rules, set number of failures, etc. A number of customers are using the system under 21 CFR Part 11 compliance and have successfully completed validation.

21 CFR Part 11 Resources

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Comparison of the Proposed Rule and Final Rule for 21 Code of Federal Regulations, Part 11
Changes have been made by the FDA in Part 11 of CFR from time to time. For instance now, the latest version of Part 11 also applies to electronic records submitted to the FDA under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.

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News and Articles

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Risk-Based Approach to 21 CFR Part 11
The use of a risk-based approach to Part 11 would allow the regulated industry to analyze their processes, identify GxP records, and implement appropriate controls to mitigate risks.

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