The US Food and Drug Administration (FDA) specifies the regulations for electronic records and signatures in 21 CFR Part 11. This guide applies to FDA-regulated industries, such as biotechnology, pharmaceutical, contract research, and medical device industries. Part 11 advises on how to handle electronic records and signatures and explains why they are equivalent to paper records. Furthermore, an organization that uses a computer system to create, maintain, or modify records needs to define the predicate rules and control their records according to the rules. Examples of predicate rules are as follows:
Controls should be implemented, such as internal audits, audit trails, system validations, electronic signature protocols, and software documentation. Additionally, an organization that uses e-signatures should comply with requirements. The objective of Part 11 is to maintain traceability and accountability of electronic records, including e-signatures. Here are some requirements:
Part 11 defines electronic records as “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.” According to the FDA, any information that is generated and stored within an electronic system must comply with requirements. Electronic records should be stored remotely or on a local hard drive. Furthermore, since you can print electronic records, treat them like paper records.
Part 11 defines the electronic signature as “a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.” Part 11 includes requirements to guarantee that electronic signatures are legally equivalent to handwritten signatures.
To handle electronic records properly and safely, you need to implement an electronic records management system. The system should have the following qualities:
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