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21cfrpart11 · A forum for issues and questions regardi

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  • Members: 2690
  • Category: Computer Science
  • Founded: Apr 14, 2000
  • Language: English
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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: Completing test scripts using word
There is no clear regulatory requirement to prevent test scripts being completed this way (using Word). If you think about it, everyone who uses a computer
Posted - Fri May 25, 2012 4:48 pm
David
david.stokes28
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Re: Completing test scripts using word
There is nothing in Part 11 that states that specifically. The regulation just isn't that detailed. Now I am pretty sure the somewhere else in the CFR there
Posted - Wed May 23, 2012 4:17 pm
Greg Ventura
gwventura
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State Regulations?
Hi, I've been part of this list for over six years, although I haven't been active in a long while. I've been a quality engineer in life-sciences for about 15
Posted - Wed May 23, 2012 4:17 pm
Alex Buck
kcubxela
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Re: GLP vs GMP
I agree in parts It is irrelevant if your laboratory is on a manufacturing site or not. What counts is the purpose of the lab. If it performs analyses that are
Posted - Wed May 23, 2012 4:16 pm
Schmitt, Siegfried
parexel
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Re: Completing test scripts using word
Here is the issue that the vendor has in my opinion:   1.  Did the person signing the script at the bottom of  the page actually execute the steps? 2.  Is
Posted - Wed May 23, 2012 4:16 pm
Robert
bonz187
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Message History

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
2012 20 18 20 24 37
2011 51 77 114 63 44 57 112 38 56 60 37 56
2010 81 67 67 59 30 27 54 25 78 34 68 2
2009 74 107 43 184 62 30 41 52 63 67 27 51
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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