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Forum: 21 CFR PART 11

The Regulations and the Predicate Rules.

  1. Sticky Thread Sticky: An Easy to Understand Guide - 21 CFR PART 11

    Started by gokeeffe, 11-09-2011 02:16 PM
    • Replies: 6
    • Views: 2,136
    07-16-2012, 03:27 PM Go to last post
  1. Laboratory Systems - ER location and protection

    Started by mirl, 03-28-2014 04:46 PM
    • Replies: 3
    • Views: 347
    04-07-2014, 02:53 PM Go to last post
  2. Password Aging

    Started by dfarago, 11-20-2012 12:50 PM
    • Replies: 2
    • Views: 1,077
    02-25-2014, 02:48 PM Go to last post
  3. Red face Equipment Process Parameters consider data?

    Started by Jesmond Siew, 01-23-2014 12:56 AM
    process parameters
    • Replies: 6
    • Views: 306
    01-27-2014, 12:34 AM Go to last post
  4. 21 CFR Part 11 - use of Electronic Signatures

    Started by mirl, 11-11-2013 03:56 PM
    • Replies: 5
    • Views: 957
    12-09-2013, 01:51 PM Go to last post
    • Replies: 1
    • Views: 364
    11-15-2013, 02:28 PM Go to last post
  5. Some thoughts about SAP validation

    Started by scotti, 11-13-2013 08:38 PM
    • Replies: 0
    • Views: 380
    11-13-2013, 08:38 PM Go to last post
  6. Open and Closed System in Part11

    Started by Jasmine, 10-16-2013 05:22 AM
    • Replies: 1
    • Views: 410
    10-16-2013, 04:26 PM Go to last post
  7. Requesting recommendation for validation course

    Started by gabi, 09-17-2013 11:44 AM
    • Replies: 1
    • Views: 355
    09-20-2013, 10:03 PM Go to last post
  8. Electronic Authorization Request Form

    Started by moogleslam, 12-05-2012 05:59 PM
    • Replies: 1
    • Views: 860
    12-06-2012, 04:10 PM Go to last post
  9. Barcode Scanners

    Started by Durwvd, 10-04-2012 12:38 PM
    • Replies: 1
    • Views: 978
    10-04-2012, 10:01 PM Go to last post
  10. SharePoint and eSignature

    Started by rmsturm, 10-03-2012 11:23 PM
    e-signature, esignature, sharepoint
    • Replies: 0
    • Views: 701
    10-03-2012, 11:23 PM Go to last post
  11. existing system

    Started by rave04, 08-13-2012 05:42 PM
    • Replies: 7
    • Views: 1,420
    08-29-2012, 04:34 AM Go to last post
  12. Requirement for Electronic Records

    Started by nwilliams, 07-12-2012 08:12 AM
    • Replies: 6
    • Views: 1,310
    08-25-2012, 12:34 PM Go to last post
  13. An Easy to Understand Guide - Annex 11

    Started by gokeeffe, 08-06-2012 09:15 AM
    • Replies: 0
    • Views: 661
    08-06-2012, 09:15 AM Go to last post
  14. Question Vision Systems - E-Records or Not??

    Started by PJK, 07-17-2012 09:35 AM
    • Replies: 4
    • Views: 1,278
    07-19-2012, 09:50 AM Go to last post
  15. Moved: Computer system validation

    Started by rave04, 06-28-2012 07:26 AM
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  16. Electronic Records CSV FDA Warning Letters

    Started by gokeeffe, 06-26-2012 10:46 AM
    • Replies: 0
    • Views: 1,669
    06-26-2012, 10:46 AM Go to last post
  17. Talking E-signature in GMP document

    Started by gireesht01, 05-07-2012 09:34 AM
    • Replies: 10
    • Views: 2,773
    06-11-2012, 11:45 AM Go to last post
  18. Moved: E-signature in SAP

    Started by Dark Validator, 09-08-2011 07:44 PM
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    • Replies: 0
    • Views: 1,700
    03-16-2012, 10:47 AM Go to last post
  19. Validation of Standalone systems

    Started by arpita, 10-26-2010 04:05 PM
    • Replies: 3
    • Views: 1,994
    03-15-2012, 05:58 AM Go to last post

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