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Tue, 30 Aug 2011 14:58:45 -0400 |
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Good afternoon!
Although I rarely see biotech industry RIM topics discussed here, I am hoping there are lots of lurkers!
This question is related to the maintaining the integrity of your GLP study data and ensuring everything is transferred to the archive at the close of the study. What processes do you have in place to comply with 40 CFR part 160.33, 21 CFR part 58.33, and OECD GLP 1997 1.2.2 (i)?
Feel free to contact me offline, since I'm sure this applies to so few.
Thanks so much!
Cherise Forbes
Sr. Global Archivist
678/638-3658
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