Title 21 CFR Part 11 Requirement

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration(FDA) regulations on electronic records and electronic signatures (ERES). 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)).

Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [1]

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IT人在工廠日記 – IT人員通常的職業病痛

在二十多年的工作生涯中,我除了賺到工資外,但是也帶來很多職業病痛。其一就是肩背痛,四年前開始發作,那時痛了二、三星期才痊愈,之後只是間歇的少痛,尤其是不跟大陸同事渴白酒後,已沒大問題,可是現在剛剛轉了新工作,肩背痛又發作,令我痛了一星期,醫生說是初期的肩周炎,現在要認真治理了。另外,二年前我曾經生蛇,應該是因為工作和生活壓力的,幸好沒有後遺症。再之後,一年半前,開始腰痛發作,不知是因為工作或是床鋪問題,總之就是痛。最後,還有一樣很普遍的辦公室人員的職業病,就是痔瘡,我已經記不起什麼時候開始的,因為一直沒大困擾,只是近年開始令我坐立不安,尤其是多行更差,很討厭呢。

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