- 6 June 2014
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The life sciences industries, including medical device manufacturers and pharmaceutical companies, are among the most heavily regulated in the world. It should therefore come as no surprise that manufacturers in these industries are considerably more focused on regulatory compliance than other manufacturers.
Complying with FDA regulations requires enormous volumes of documentation. At one time, life sciences companies literally shipped truckloads of documents to the FDA to meet their regulatory requirements. To streamline work processes related to this documentation, manufacturers began looking to manage documents electronically. However, because electronic documents are subject to greater risks of falsification, misrepresentation, and change without leaving evidence than paper records, the FDA determined that electronic documents required special controls.
The result was 21 CFR Part 11, a set of regulations that govern the way FDA regulated industries manage electronic records and electronic signatures. Written in 1997, 21 CFR Part 11 establishes the criteria under which electronic records and signatures can be considered equivalent to paper-based records and handwritten signatures.
21 CFR Part 11 applies to electronic records and signatures that support FDA predicate rules. Predicate rules are previously published regulations under which organizations already operate, such as Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Processes (GMP). It is not 21 CFR Part 11, but these predicate rules that determine to which data or records 21 CFR Part 11 applies.
Organizations that fail to comply with 21 CFR Part 11 face severe consequences. These can include warning letters, mandatory product recalls, temporary shut downs, criminal penalties and fines, depending on the severity of the violations. The penalties imposed by the FDA could seriously damage the manufacturer’s brand image and even cripple the manufacturer financially.
Requirements for 21 CFR Part 11 Compliance
Practically speaking, 21 CFR Part 11 requires FDA regulated manufacturers that wish to use electronic documents and signatures to meet the following four categories of requirements:
Validation—Companies must validate that the software and systems used to create and maintain electronic records and signatures are able to ensure the integrity of the electronic results and information.
Security—Companies need to maintain confidentiality and integrity of the information contained in electronic records by controlling rights and access.
Accountability—Companies must ensure that individuals are held accountable for their electronic acts with regard to electronic documents by creating and preserving electronic forensic evidence.
Nonrepudiation—Manufacturers must guarantee that someone using an electronic signature cannot readily repudiate the signed record as not genuine and provide a way to legally enforce electronic signatures. While 21 CFR Part 11 describes the FDA’s requirements for acceptable electronic records, it does not specify a particular implementation. Instead, 21 CFR Part 11 provides a set of guidelines that are based on common sense and good workflow, acting as a codification of good laboratory practice. By addressing these guidelines, medical device manufacturers not only comply with FDA regulations, they can also improve the security and efficiency of their document-based workflows.
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