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Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: 11 — electronic records and electronic signature related; 50 Protection of human subjects in clinical trials; 54 Financial disclosure by clinical investigators [2] 56 Institutional review boards that oversee clinical trials
Compliance requirements are only guidelines for compliance with the hundreds of laws and regulations applicable to the specific type assistance used by the recipient, and their objectives are generic in nature due to the large number of federal programs. [1] Each compliance requirement is identified by a letter, in alphabetical order.
CFR Title 11 – Federal Elections is one of 50 titles composing the United States Code of Federal Regulations (CFR) and contains the principal set of rules and regulations issued by federal agencies regarding federal elections.
In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...
Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]
Title 21 CFR Part 11; Title 47 CFR Part 15; ... Title 49 CFR Part 600 - 699; Treasury regulations This page was last edited on 29 December 2013, at 13:40 (UTC ...