Part 11 References

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  • Computerized Systems Used In Clinical Investigations

  • Computerized Systems Used In Clinical Trials

  • Part 11 Scope and Application

  • General Principles of Computer System Validation

  • Computer Systems Validation Guidelines

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    John 0 2551 10-12-08 02:29 AM
    by John
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    Natalie 0 2803 02-06-10 06:39 PM
    by Natalie
    No New Posts Query about Method Validation of Thiocyanate
       
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    JohanJ 4 3910 11-30-09 12:16 AM
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    IHN1 0 2362 11-26-09 01:09 AM
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    royhobbs 1 5466 06-28-09 08:48 AM
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    Ndiggs 3 4202 05-19-09 02:58 AM
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    sdnare 1 3725 03-31-09 07:21 PM
    by JohanJ
    No New Posts Does this require 21 CFR Part 11 Compliance?
       
    tcg 4 4583 02-11-09 09:23 AM
    by Guerra Parafino
    No New Posts Inspection Equipment
       
    jfollosco 2 2860 12-01-08 08:37 PM
    by JohanJ
    No New Posts a question about signature
       
    ebuss 8 5136 11-18-08 04:47 AM
    by ebuss
    No New Posts 21 CFR PART 11
       
    sdnare 4 4886 10-18-08 03:44 AM
    by Steven Walter
    No New Posts 21CFR part 11 consultant
       
    lee 4 6465 10-17-08 07:42 AM
    by Steven Walter
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    madrush68 2 2878 10-02-08 12:28 AM
    by JohanJ
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    k75 0 2592 09-30-08 08:55 PM
    by k75
    No New Posts Electronic Signatures
       
    lprice 2 3955 09-05-08 08:27 AM
    by Todd QA
    No New Posts certification in computer system validation
       
    sdnare 1 4168 07-22-08 09:28 AM
    by Altiger
    No New Posts How to do NMR method validation?
       
    frankcyd 2 5079 07-07-08 09:07 PM
    by frankcyd
    No New Posts Is Master Project plan (QA) gover Validation Master Plan or vice versa?
       
    Jagram 7 7004 06-30-08 11:30 PM
    by Alex Kennedy
    No New Posts Validation of Autoclaves
       
    Finnbar 2 5071 05-27-08 03:03 AM
    by JohanJ
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    John 0 2687 04-30-08 06:32 AM
    by John
    No New Posts GAMP Categorisation
       
    valiveti 1 4407 04-07-08 09:46 PM
    by JohanJ
    No New Posts module 1 folder naming
       
    amit gajjar 0 4105 03-30-08 04:46 PM
    by amit gajjar
    No New Posts the content of module 3? (CTD)
       
    orange-juzi 0 5815 03-24-08 01:08 PM
    by orange-juzi
    No New Posts Questions about eCTD to FDA
       
    F2Andy 3 7100 03-20-08 10:51 PM
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    sbwcm 4 12300 03-19-08 12:31 AM
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    lprice 0 3248 02-27-08 03:56 AM
    by lprice
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    Orit 1 4336 02-24-08 11:04 PM
    by JohanJ
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    arpitp 1 8574 02-14-08 01:14 AM
    by IHN1
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    dontemu 2 3808 02-04-08 07:03 AM
    by Frank C.
    No New Posts What Category?
       
    Graham O'Keeffe 3 6856 01-15-08 02:53 AM
    by JohanJ
    No New Posts SAP Modules SD/MM, FI/CO,HR, ABAP
        Page: 1 2 All
    Anonymous 22 52878 01-14-08 05:18 AM
    by ahmudg
    No New Posts digital images and Part 11
       
    belle 1 4128 09-19-07 06:37 PM
    by PaulS
    No New Posts Autoclaves: Thermocouples Versus Val Probes
       
    Finnbar 2 5261 09-17-07 01:17 AM
    by Graham O'Keeffe
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    Jagram 1 4131 07-24-07 07:37 AM
    by YHJ
    No New Posts Document Signer left the job
       
    YHJ 2 4319 07-19-07 07:24 AM
    by YHJ
    No New Posts Thermal Mapping Autoclaves
       
    Finnbar 0 3895 06-07-07 03:12 AM
    by Finnbar
    No New Posts Part 11 and GLPs
       
    Sunhorse 1 4461 05-24-07 07:15 AM
    by John
    No New Posts Grandfather clause for Legacy Systems
       
    IHN1 1 5477 05-08-07 07:05 AM
    by John
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    John 0 3970 03-22-07 07:08 AM
    by John
    No New Posts Electronic Record Destruction
       
    belle 0 3993 03-16-07 04:02 AM
    by belle
    No New Posts New 21 cfr part 11 rule
       
    Mobi Maniak 3 8721 03-08-07 05:31 PM
    by PaulS
    No New Posts eSubmissions to FDA
       
    Orit 2 4778 02-28-07 08:52 PM
    by Orit
    No New Posts Audit Trials and Access
       
    mac 1 5054 02-25-07 09:51 AM
    by John
    No New Posts White papers of interest - Very informative
       
    Graham O'Keeffe 1 5153 01-18-07 11:21 AM
    by mjgregor
    No New Posts Part 11 and DB's
       
    Graham O'Keeffe 1 4660 12-26-06 02:31 PM
    by arf2000
    No New Posts Access Database
       
    Anonymous 3 7430 12-09-06 08:26 AM
    by Mark Khayter
    No New Posts When electronic record does not triger PART 11?
       
    Anonymous 10 10727 12-09-06 08:16 AM
    by Mark Khayter
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