In the context of 21 CFR, the terms "document" and "record" have specific meanings:
1. Document: A document typically refers to any written, printed, or electronic information that provides evidence of activities, events, or decisions related to the manufacturing, processing, packing, holding, or distribution of a product.
Documents can include specifications, SOPs, procedures, protocols, reports, manuals etc.
Documents are essential for establishing and maintaining compliance with regulatory requirements and ensuring the quality and safety of products in pharmaceutical industry.
2. Record: A record, on the other hand, refers to a specific type of document that provides evidence of activities performed or results achieved.
Records are typically more formal and are used to demonstrate compliance with regulatory requirements. They may include data, observations, measurements, test results, and other information that is generated during the production, manufacturing, testing, or distribution of a product.
Records are often subject to specific regulatory requirements regarding their creation, maintenance, retention, and accessibility.
"While all records are documents, not all documents are records".
Records are a subset of documents that serve as formal evidence of compliance with regulatory requirements and document specific activities or results in detail.
Both documents and records play crucial roles in ensuring regulatory compliance and maintaining the quality and safety of products regulated by 21 CFR (Code of Federal Regulations).
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