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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: 3,144
    07-16-2012, 03:27 PM Go to last post
  1. 21 CFR 11.10(f): Operational System Checks

    Started by AM77, 05-27-2015 11:16 AM
    • Replies: 8
    • Views: 775
    05-29-2015, 06:57 AM Go to last post
    • Replies: 6
    • Views: 2,950
    05-26-2015, 02:55 PM Go to last post
    • Replies: 2
    • Views: 1,050
    02-09-2015, 02:13 PM Go to last post
  2. Validation for non CFR compliant equipment

    Started by eliasmorany, 10-08-2014 07:19 AM
    21 cfr part 11
    • Replies: 2
    • Views: 1,041
    10-12-2014, 06:52 AM Go to last post
    • Replies: 3
    • Views: 814
    10-02-2014, 07:44 PM Go to last post
  3. Validation Balance Calculation

    Started by becchino, 07-01-2014 01:44 PM
    • Replies: 0
    • Views: 740
    07-01-2014, 01:44 PM Go to last post
    • Replies: 0
    • Views: 618
    05-21-2014, 07:53 PM Go to last post
    • Replies: 3
    • Views: 1,175
    04-14-2014, 01:23 PM Go to last post
  4. Laboratory Systems - ER location and protection

    Started by mirl, 03-28-2014 04:46 PM
    • Replies: 3
    • Views: 1,014
    04-07-2014, 02:53 PM Go to last post
    • Replies: 4
    • Views: 906
    03-01-2014, 12:13 PM Go to last post
  5. Password Aging

    Started by dfarago, 11-20-2012 12:50 PM
    • Replies: 2
    • Views: 1,818
    02-25-2014, 02:48 PM Go to last post
  6. Red face Equipment Process Parameters consider data?

    Started by Jesmond Siew, 01-23-2014 12:56 AM
    process parameters
    • Replies: 6
    • Views: 1,015
    01-27-2014, 12:34 AM Go to last post
  7. 21 CFR Part 11 - use of Electronic Signatures

    Started by mirl, 11-11-2013 03:56 PM
    • Replies: 5
    • Views: 3,352
    12-09-2013, 01:51 PM Go to last post
    • Replies: 1
    • Views: 733
    11-15-2013, 02:28 PM Go to last post
  8. Some thoughts about SAP validation

    Started by scotti, 11-13-2013 08:38 PM
    • Replies: 0
    • Views: 789
    11-13-2013, 08:38 PM Go to last post
  9. Open and Closed System in Part11

    Started by Jasmine, 10-16-2013 05:22 AM
    • Replies: 1
    • Views: 1,102
    10-16-2013, 04:26 PM Go to last post
    • Replies: 1
    • Views: 1,467
    10-14-2013, 03:41 PM Go to last post
  10. Requesting recommendation for validation course

    Started by gabi, 09-17-2013 11:44 AM
    • Replies: 1
    • Views: 723
    09-20-2013, 10:03 PM Go to last post
    • Replies: 0
    • Views: 1,515
    02-18-2013, 07:33 PM Go to last post
    • Replies: 0
    • Views: 951
    01-07-2013, 08:09 PM Go to last post
  11. Electronic Authorization Request Form

    Started by moogleslam, 12-05-2012 05:59 PM
    • Replies: 1
    • Views: 1,216
    12-06-2012, 04:10 PM Go to last post
  12. Barcode Scanners

    Started by Durwvd, 10-04-2012 12:38 PM
    • Replies: 1
    • Views: 1,398
    10-04-2012, 10:01 PM Go to last post
  13. SharePoint and eSignature

    Started by rmsturm, 10-03-2012 11:23 PM
    e-signature, esignature, sharepoint
    • Replies: 0
    • Views: 1,123
    10-03-2012, 11:23 PM Go to last post
  14. existing system

    Started by rave04, 08-13-2012 05:42 PM
    • Replies: 7
    • Views: 2,001
    08-29-2012, 04:34 AM Go to last post
  15. Requirement for Electronic Records

    Started by nwilliams, 07-12-2012 08:12 AM
    • Replies: 6
    • Views: 1,891
    08-25-2012, 12:34 PM Go to last post
    • Replies: 1
    • Views: 2,168
    08-24-2012, 10:09 PM Go to last post
  16. An Easy to Understand Guide - Annex 11

    Started by gokeeffe, 08-06-2012 09:15 AM
    • Replies: 0
    • Views: 956
    08-06-2012, 09:15 AM Go to last post
  17. Question Vision Systems - E-Records or Not??

    Started by PJK, 07-17-2012 09:35 AM
    • Replies: 4
    • Views: 1,970
    07-19-2012, 09:50 AM Go to last post
  18. Moved: Computer system validation

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

    Started by gokeeffe, 06-26-2012 10:46 AM
    • Replies: 0
    • Views: 2,880
    06-26-2012, 10:46 AM Go to last post

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