In section 11.10 Controls for closed systems, FDA requires: These are the key requirements that you must consider when implementing a 21 CFR Part 11 compliant document management solution. What Are the Requirements of 21 CFR Part 11? This means that not only your documents are in scope but also: “(6) 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.” However, if you have uploaded quality critical documents onto any computer system it is almost certain that the regulatory framework will apply to you.įurthermore, in section 11.3 Definitions, the FDA defines “electronic record” as: Then, of course, 21 CFR Part 11 does not apply to your company.
Therefore, the regulatory framework applies to any company within the FDA-regulated industry that manages electronic records and electronic signatures.īut what if you have all your “master records” on a paper format and nowhere else? “(b) 21 CFR Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth by the FDA.” In section 11.1 Scope, the FDA defines the “scope” of the regulation in the following way: Put simply, the regulation outlines the handling of electronic records which are a part of Electronic Quality Management Systems (eQMS) and other quality-critical applications. In section 11.1 Scope (a), the regulation defines the criteria for electronic records and electronic signatures under which they are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
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Part 11 of Title 21 in the Code of Federal Regulations, or 21 CFR Part 11, more commonly referred to as “Part 11” is a set of rules that specify the requirements for electronic records and signatures.
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