Source: https://www.easyglobaltraining.com/product/the-latest-update-on-21-cfr-part-11/
Timestamp: 2019-04-19 22:28:49
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The Latest Update on 21 CFR Part 11 | Easy Global Training
Tags: e-Book, online course, online training, quality compliance, 21 CFR Part 11, Electronic documents, electronic signature, Easy Global training, Afsaneh Motamed, Part 11, e-signature, e-document
In March of 1997, FDA issued final 21 CFR Part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.
FDA has spoken about part 11 at many conferences and has issued 6 pieces of draft guidance to help interpret 21 CFR Part 11 in the past. However, concerns have been raised particularly in the areas of its requirements for validation, audit trails, record retention, record copying, and legacy systems.
On February 25, 2003 (68 FR 5645), FDA announced the withdrawal of the 21 CFR Part 11 draft guidance documents on validation, glossary of terms, time stamps, maintenance of electronic records, and CPG 7153.17. In Aug 2003, the last guidance was issued to describe how FDA intended to exercise enforcement discretion with regard to certain part 11 requirements during the re-examination of 21 CFR Part 11.
This e-Book discusses 21 CFR Part 11 since it remains in effect during FDA reexamination period. Also, we will elaborate on the latest guidance published in Aug 2003.
By reading / following this 21 CFR Part 11 e-Book, you will be able to:
Understand the history / current situation of 21 CFR Part 11
Comprehend how 21 CFR Part 11 applies to what you do
Become familiar with the aspects of previous FDA guidance documents to address e-records / e-signatures
Become familiar with the latest guidance document published by FDA as of Aug 2003 for 21 CFR Part 11
Who Can Benefit From This 21 CFR Part 11 e-Book
Lab managers (pharmaceutical & medical device industry)
Date of Last Update: Aug 07, 2018