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21 CFR Parts 11 and 101 Gpo Form
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People also ask
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What are 21 CFR Part 11 requirements?
Part 11 specifies that any e-signatures applied to documents must include the printed name of the signer, the date/time the signature was applied, and the 'meaning' or intention of the electronic signature as part of an evolving and uneditable audit trail.
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What is 21 CFR Part 11 for dummies?
“21 CFR Part 11” refers to a particular chunk of the Code of Federal Regulations issued by the United States to regulate drugs. Specifically, it means: Title 21 > Chapter 1 > Subchapter A > Part 11. Part 11 applies to all electronic records that fall under FDA regulations.
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What is the equivalent of 21 CFR Part 11?
Annex 11 is the European equivalent of the FDA's 21 CFR Part 11. Part 11 includes electronic records and electronic signatures for FDA-regulated activities. Annex 11 covers computerized systems for GMP-regulated activities.
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What are the authority checks in 21 CFR Part 11?
Text of 21 CFR 11.10(g) 11.10(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
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What are the requirements for 21 CFR Part 11?
Control and authentication E-signatures must be unique to individuals. E-signatures must be password protected (with passwords changed frequently) Only administrators should be able to control the use of e-signatures in the system. Signatures must be authenticated in real-time when they are used.
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What is an open system in 21 CFR Part 11?
Open Systems are computer systems where system access is not controlled by people responsible for the content of electronic records in the system. The internet or wikis are examples of open systems. Procedural Controls are documented SOPs which ensure that a system is only used in a particular manner.
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What are the three primary areas of 21 CFR Part 11?
We receive many questions on 21 CFR Part 11 and Annex 11. In this article, we offer some background and a brief overview of three focal points of both of the "Elevens" including System Controls, Validation and Archiving.
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What is 21 CFR Part 11 compliance checklist?
The 21 CFR Part 11 compliance checklist is a tool that can be used to evaluate the level of compliance with the requirements outlined in 21 CFR Part 11. It provides a comprehensive list of questions to consider when assessing the compliance of electronic records and electronic signature systems.
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