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21cfrpart11 · A forum for issues and questions regardi

Group Information

  • Members: 2723
  • Category: Computer Science
  • Founded: Apr 14, 2000
  • Language: English
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Description

A forum for issues and questions regarding 21 CFR Part 11. The 21CFRpart11.com Discussion Mail List is for comments or questions about the 21 CFR Part 11 Electronic Records Electronic Signatures Rule. You will receive messages posted to the list and you will be able to post and reply to messages.

The members list is private and is not accessible by anyone other than the moderator. This mail list is moderated. SPAM, flames, or inappropriate messages will be filtered out before they are sent to you.

Our vision at 21CFRpart11.com, for this mail list, is that it should be a dynamic forum for industry professionals and vendors to freely exchange ideas and solve problems. We want to be sure that the demeanor of the mail list reflects the desires of the subscribers.

The majority of the subscribers have indicated that they do not want to receive unsolicited sales or promotional messages in this forum, or to have overtly commercial or promotional postings.

Commercial, promotional or other postings deemed by the Moderators to be inappropriate for this list may be deleted without notice. This includes, but is not limited to, advertising or promoting: products, services, companies, job postings or other messages deemed to be commercial in nature as determined by the moderators of this group.

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Re: Good Documentation Practices
Specifically, 58.130(e) Dirk From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of Paula Wehmeyer Sent: Wednesday, November 25,
Posted - Wed Nov 25, 2009 8:07 pm
Hoogenboom, Dirk
dwhgnbm
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Re: Good Documentation Practices
You might try 21 CFR Part 58 (the GLPs) for a pretty solid description. Thank you, Paula My opinions are my own and do not necessarily represent those of my
Posted - Wed Nov 25, 2009 8:00 pm
Paula Wehmeyer
p.wehmeyer01
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Good Documentation Practices
HI All- I know what Good Documentation Practices are, but can anyone point me to the predicate rules which mention these are necessary? I am noticing in my new
Posted - Wed Nov 25, 2009 4:51 pm
computersystemcomplia...
computersyst...
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Re: Vendor Validates - In house qualification?
Awesome! Thanks for the response... I felt the same way, and when you spelled it out, it reassures me that we do have to perform in house testing, such as the
Posted - Wed Nov 25, 2009 4:48 pm
computersystemcomplia...
computersyst...
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Re: Vendor Validates - In house qualification?
Only you know your requirements - they can only surmise what these are. You need to demonstrate that the application meets your requirements or, in the event
Posted - Wed Nov 25, 2009 4:31 pm
Martin G. Knop
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Message History

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
2009 74 107 43 184 62 30 41 52 63 67 25
2008 132 144 164 266 167 184 94 100 157 85 101 37
2007 85 71 143 94 172 59 119 65 66 97 54 62
2006 124 137 187 102 148 87 81 212 42 171 88 97
2005 186 182 197 138 125 113 165 191 110 168 164 126
2004 304 277 240 213 153 139 225 206 168 186 254 134
2003 369 391 271 228 181 375 306 282 316 237 218 109
2002 550 457 354 272 300 326 350 374 354 497 318 265
2001 166 112 155 130 132 139 178 219 138 318 331 275
2000 1 2 30 65 76 90 65 115

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