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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: 2,412
    07-16-2012, 03:27 PM Go to last post
  1. Validation Balance Calculation

    Started by becchino, 07-01-2014 01:44 PM
    • Replies: 0
    • Views: 348
    07-01-2014, 01:44 PM Go to last post
    • Replies: 0
    • Views: 298
    05-21-2014, 07:53 PM Go to last post
    • Replies: 3
    • Views: 710
    04-14-2014, 01:23 PM Go to last post
  2. Laboratory Systems - ER location and protection

    Started by mirl, 03-28-2014 04:46 PM
    • Replies: 3
    • Views: 554
    04-07-2014, 02:53 PM Go to last post
    • Replies: 0
    • Views: 216
    04-02-2014, 04:06 PM Go to last post
    • Replies: 4
    • Views: 410
    03-01-2014, 12:13 PM Go to last post
  3. Password Aging

    Started by dfarago, 11-20-2012 12:50 PM
    • Replies: 2
    • Views: 1,219
    02-25-2014, 02:48 PM Go to last post
  4. Red face Equipment Process Parameters consider data?

    Started by Jesmond Siew, 01-23-2014 12:56 AM
    process parameters
    • Replies: 6
    • Views: 453
    01-27-2014, 12:34 AM Go to last post
  5. 21 CFR Part 11 - use of Electronic Signatures

    Started by mirl, 11-11-2013 03:56 PM
    • Replies: 5
    • Views: 1,335
    12-09-2013, 01:51 PM Go to last post
    • Replies: 1
    • Views: 455
    11-15-2013, 02:28 PM Go to last post
  6. Some thoughts about SAP validation

    Started by scotti, 11-13-2013 08:38 PM
    • Replies: 0
    • Views: 482
    11-13-2013, 08:38 PM Go to last post
  7. Open and Closed System in Part11

    Started by Jasmine, 10-16-2013 05:22 AM
    • Replies: 1
    • Views: 640
    10-16-2013, 04:26 PM Go to last post
    • Replies: 1
    • Views: 1,080
    10-14-2013, 03:41 PM Go to last post
  8. Requesting recommendation for validation course

    Started by gabi, 09-17-2013 11:44 AM
    • Replies: 1
    • Views: 432
    09-20-2013, 10:03 PM Go to last post
    • Replies: 0
    • Views: 1,261
    02-18-2013, 07:33 PM Go to last post
    • Replies: 0
    • Views: 737
    01-07-2013, 08:09 PM Go to last post
  9. Electronic Authorization Request Form

    Started by moogleslam, 12-05-2012 05:59 PM
    • Replies: 1
    • Views: 957
    12-06-2012, 04:10 PM Go to last post
  10. Barcode Scanners

    Started by Durwvd, 10-04-2012 12:38 PM
    • Replies: 1
    • Views: 1,079
    10-04-2012, 10:01 PM Go to last post
  11. SharePoint and eSignature

    Started by rmsturm, 10-03-2012 11:23 PM
    e-signature, esignature, sharepoint
    • Replies: 0
    • Views: 814
    10-03-2012, 11:23 PM Go to last post
  12. existing system

    Started by rave04, 08-13-2012 05:42 PM
    • Replies: 7
    • Views: 1,542
    08-29-2012, 04:34 AM Go to last post
  13. Requirement for Electronic Records

    Started by nwilliams, 07-12-2012 08:12 AM
    • Replies: 6
    • Views: 1,440
    08-25-2012, 12:34 PM Go to last post
    • Replies: 1
    • Views: 1,608
    08-24-2012, 10:09 PM Go to last post
  14. An Easy to Understand Guide - Annex 11

    Started by gokeeffe, 08-06-2012 09:15 AM
    • Replies: 0
    • Views: 737
    08-06-2012, 09:15 AM Go to last post
  15. Question Vision Systems - E-Records or Not??

    Started by PJK, 07-17-2012 09:35 AM
    • Replies: 4
    • Views: 1,427
    07-19-2012, 09:50 AM Go to last post
  16. Moved: Computer system validation

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

    Started by gokeeffe, 06-26-2012 10:46 AM
    • Replies: 0
    • Views: 2,021
    06-26-2012, 10:46 AM Go to last post
  18. Talking E-signature in GMP document

    Started by gireesht01, 05-07-2012 09:34 AM
    • Replies: 10
    • Views: 3,140
    06-11-2012, 11:45 AM Go to last post
    • Replies: 5
    • Views: 2,316
    06-11-2012, 11:09 AM Go to last post
  19. Moved: E-signature in SAP

    Started by Dark Validator, 09-08-2011 07:44 PM
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    • Replies: 0
    • Views: 932
    03-28-2012, 06:23 PM Go to last post

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