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21cfrpart11 · A forum for issues and questions regardi

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  • Members: 2746
  • 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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MDD 2007/47/EC Research
Hi all, I know this is a little off topic, but I am working on a research project on the med device industry's thoughts as to the impact of the impending
Posted - Wed Jul 8, 2009 6:38 pm
sara.camden
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Re: 21 CFR Part 11 and REMS
That is certainly possible. There are quite a few interested parties involved and the primary relationship would seem to be between physician and patient,
Posted - Wed Jul 8, 2009 3:33 pm
Graham Tinsley
graham_tinsl...
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Re: 21 CFR Part 11 and REMS
REMS are mostly written using MS Word, so it's difficult to see where Part 11 comes in Siegfried ________________________________ From:
Posted - Wed Jul 8, 2009 3:32 pm
Schmitt, Siegfried
parexel
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Re: 21 CFR Part 11 and REMS
Graham, can it be that the FDA is referring to the Part 11 compliance of a computerized system used to monitor post-marketing REMS and maybe HIPAA for
Posted - Wed Jul 8, 2009 1:05 pm
Acosta_Harry
Acosta_Harry@...
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Re: 21 CFR Part 11 and REMS
Unless you are able to provide more specific examples (e.g. what REMS program, which supporting system?) then from the information you have provided I would
Posted - Tue Jul 7, 2009 4:05 pm
Graham Tinsley
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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 10
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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