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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 03:16 PM
    • Replies: 6
    • Views: 2,571
    07-16-2012, 04:27 PM Go to last post
  1. Validation for non CFR compliant equipment

    Started by eliasmorany, 10-08-2014 08:19 AM
    21 cfr part 11
    • Replies: 2
    • Views: 339
    10-12-2014, 07:52 AM Go to last post
    • Replies: 3
    • Views: 250
    10-02-2014, 08:44 PM Go to last post
    • Replies: 1
    • Views: 312
    09-22-2014, 08:43 PM Go to last post
  2. Validation Balance Calculation

    Started by becchino, 07-01-2014 02:44 PM
    • Replies: 0
    • Views: 508
    07-01-2014, 02:44 PM Go to last post
    • Replies: 0
    • Views: 364
    05-21-2014, 08:53 PM Go to last post
    • Replies: 3
    • Views: 789
    04-14-2014, 02:23 PM Go to last post
  3. Laboratory Systems - ER location and protection

    Started by mirl, 03-28-2014 05:46 PM
    • Replies: 3
    • Views: 657
    04-07-2014, 03:53 PM Go to last post
    • Replies: 4
    • Views: 513
    03-01-2014, 01:13 PM Go to last post
  4. Password Aging

    Started by dfarago, 11-20-2012 01:50 PM
    • Replies: 2
    • Views: 1,343
    02-25-2014, 03:48 PM Go to last post
  5. Red face Equipment Process Parameters consider data?

    Started by Jesmond Siew, 01-23-2014 01:56 AM
    process parameters
    • Replies: 6
    • Views: 554
    01-27-2014, 01:34 AM Go to last post
  6. 21 CFR Part 11 - use of Electronic Signatures

    Started by mirl, 11-11-2013 04:56 PM
    • Replies: 5
    • Views: 1,535
    12-09-2013, 02:51 PM Go to last post
    • Replies: 1
    • Views: 511
    11-15-2013, 03:28 PM Go to last post
  7. Some thoughts about SAP validation

    Started by scotti, 11-13-2013 09:38 PM
    • Replies: 0
    • Views: 530
    11-13-2013, 09:38 PM Go to last post
  8. Open and Closed System in Part11

    Started by Jasmine, 10-16-2013 06:22 AM
    • Replies: 1
    • Views: 737
    10-16-2013, 05:26 PM Go to last post
    • Replies: 1
    • Views: 1,168
    10-14-2013, 04:41 PM Go to last post
  9. Requesting recommendation for validation course

    Started by gabi, 09-17-2013 12:44 PM
    • Replies: 1
    • Views: 486
    09-20-2013, 11:03 PM Go to last post
    • Replies: 0
    • Views: 1,316
    02-18-2013, 08:33 PM Go to last post
    • Replies: 0
    • Views: 772
    01-07-2013, 09:09 PM Go to last post
  10. Electronic Authorization Request Form

    Started by moogleslam, 12-05-2012 06:59 PM
    • Replies: 1
    • Views: 997
    12-06-2012, 05:10 PM Go to last post
  11. Barcode Scanners

    Started by Durwvd, 10-04-2012 01:38 PM
    • Replies: 1
    • Views: 1,141
    10-04-2012, 11:01 PM Go to last post
  12. SharePoint and eSignature

    Started by rmsturm, 10-04-2012 12:23 AM
    e-signature, esignature, sharepoint
    • Replies: 0
    • Views: 869
    10-04-2012, 12:23 AM Go to last post
  13. existing system

    Started by rave04, 08-13-2012 06:42 PM
    • Replies: 7
    • Views: 1,633
    08-29-2012, 05:34 AM Go to last post
  14. Requirement for Electronic Records

    Started by nwilliams, 07-12-2012 09:12 AM
    • Replies: 6
    • Views: 1,520
    08-25-2012, 01:34 PM Go to last post
    • Replies: 1
    • Views: 1,751
    08-24-2012, 11:09 PM Go to last post
  15. An Easy to Understand Guide - Annex 11

    Started by gokeeffe, 08-06-2012 10:15 AM
    • Replies: 0
    • Views: 780
    08-06-2012, 10:15 AM Go to last post
  16. Question Vision Systems - E-Records or Not??

    Started by PJK, 07-17-2012 10:35 AM
    • Replies: 4
    • Views: 1,528
    07-19-2012, 10:50 AM Go to last post
  17. Moved: Computer system validation

    Started by rave04, 06-28-2012 08:26 AM
    •  
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  18. Electronic Records CSV FDA Warning Letters

    Started by gokeeffe, 06-26-2012 11:46 AM
    • Replies: 0
    • Views: 2,178
    06-26-2012, 11:46 AM Go to last post
  19. Talking E-signature in GMP document

    Started by gireesht01, 05-07-2012 10:34 AM
    • Replies: 10
    • Views: 3,419
    06-11-2012, 12:45 PM Go to last post
    • Replies: 5
    • Views: 2,435
    06-11-2012, 12:09 PM Go to last post

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