Re: Pharmaceutical Industry Buzz Words
Justin, I've noticed some jobs lately in the Houston area requesting
knowledge of CFR Part 11. I wanted to find out more about it, so I went to
Google and did a search, and these Web sites looked promising:
You can also check the FDA Web site for more information.
The FDA site has a lot of info, and a less than perfect navigation system. The terms Justin mentioned are all important for any company that is regulated by the FDA, not just the pharmaceutical industry. My experience came through projects with several medical device manufacturers and one project that involved clinical trials data transfer.
I started with the FDAs own primer on regulatory compliance. It's buried several layers deep in their web site and, unless you know you're looking for 'compliance' terms, and include that term in your search, it will be buried somewhere in 8 or 9 pages of related but less useful material.
21 CFR Part 11, the regulations for electronic data files and electronic signatures that wordsync mentioned, is about halfway down the page.
Many of the other FDA compliance documents contain helpful glossaries, as did the draft version (haven't looked at the final pdfs) of the Quality Systems/Good Manufacuturing Practices report
and the Laboratory Procedures Manual and information bulletins.
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