Location:  Main Index » Forum Index » General Discussion » 21 CFR Part 11



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 1434 10-12-08 02:29 AM
    by John
    No New Posts learning management system and Part 11 compliance
            		Natalie 0 352 02-06-10 06:39 PM
    by Natalie
    No New Posts Query about Method Validation of Thiocyanate
            		Rajneesh Jain 0 815 12-03-09 04:01 PM
    by Rajneesh Jain
    No New Posts Electronic Signature - Teaser
            		JohanJ 4 1993 11-30-09 12:16 AM
    by JohanJ
    No New Posts Part 11 FDA Certification
            		IHN1 0 718 11-26-09 01:09 AM
    by IHN1
    No New Posts IQ OQ Protocol FTIR
            		royhobbs 1 2558 06-28-09 08:48 AM
    by YungPharma
    No New Posts Temperature Mapping and 21 CFR Compliance
            		Ndiggs 3 1562 05-19-09 02:58 AM
    by Alex Kennedy
    No New Posts 21 CFR part 11
            		sdnare 1 2076 03-31-09 07:21 PM
    by JohanJ
    No New Posts Does this require 21 CFR Part 11 Compliance?
            		tcg 4 2248 02-11-09 09:23 AM
    by Guerra Parafino
    No New Posts Inspection Equipment
            		jfollosco 2 1426 12-01-08 08:37 PM
    by JohanJ
    No New Posts a question about signature
            		ebuss 8 2648 11-18-08 04:47 AM
    by ebuss
    No New Posts 21 CFR PART 11
            		sdnare 4 2710 10-18-08 03:44 AM
    by Steven Walter
    No New Posts 21CFR part 11 consultant
            		lee 4 4349 10-17-08 07:42 AM
    by Steven Walter
    No New Posts New System Location
            		madrush68 2 1467 10-02-08 12:28 AM
    by JohanJ
    No New Posts details about SAP S&D
            		k75 0 1350 09-30-08 08:55 PM
    by k75
    No New Posts Electronic Signatures
            		lprice 2 2212 09-05-08 08:27 AM
    by Todd QA
    No New Posts certification in computer system validation
            		sdnare 1 1876 07-22-08 09:28 AM
    by Altiger
    No New Posts How to do NMR method validation?
            		frankcyd 2 2144 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 4091 06-30-08 11:30 PM
    by Alex Kennedy
    No New Posts Validation of Autoclaves
            		Finnbar 2 3072 05-27-08 03:03 AM
    by JohanJ
    No New Posts Left Side References
            		John 0 1546 04-30-08 06:32 AM
    by John
    No New Posts GAMP Categorisation
            		valiveti 1 1987 04-07-08 09:46 PM
    by JohanJ
    No New Posts module 1 folder naming
            		amit gajjar 0 2153 03-30-08 04:46 PM
    by amit gajjar
    No New Posts the content of module 3? (CTD)
            		orange-juzi 0 2520 03-24-08 01:08 PM
    by orange-juzi
    No New Posts Questions about eCTD to FDA
            		F2Andy 3 4039 03-20-08 10:51 PM
    by amit gajjar
    No New Posts Predicate Rules
            		sbwcm 4 7753 03-19-08 12:31 AM
    by shan_amudha
    No New Posts Closed and Open system
            		shan_amudha 5 3887 03-04-08 11:00 PM
    by JohanJ
    No New Posts Fill Volume for Bulk Bins
            		TMY 0 1939 03-02-08 09:55 PM
    by TMY
    No New Posts emailing patient information
            		lprice 0 1900 02-27-08 03:56 AM
    by lprice
    No New Posts FDA requirements for computerized systems and ERP
            		Orit 1 2332 02-24-08 11:04 PM
    by JohanJ
    No New Posts Master Validation Plan.
            		arpitp 1 4250 02-14-08 01:14 AM
    by IHN1
    No New Posts Protection of documents against changes
            		dontemu 2 2115 02-04-08 07:03 AM
    by Frank C.
    No New Posts What Category?
            		Graham O'Keeffe 3 4230 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 25918 01-14-08 05:18 AM
    by ahmudg
    No New Posts digital images and Part 11
            		belle 1 2443 09-19-07 06:37 PM
    by PaulS
    No New Posts Autoclaves: Thermocouples Versus Val Probes
            		Finnbar 2 3176 09-17-07 01:17 AM
    by Graham O'Keeffe
    No New Posts Audit Questions
            		Jagram 1 2611 07-24-07 07:37 AM
    by YHJ
    No New Posts Document Signer left the job
            		YHJ 2 2788 07-19-07 07:24 AM
    by YHJ
    No New Posts Thermal Mapping Autoclaves
            		Finnbar 0 2501 06-07-07 03:12 AM
    by Finnbar
    No New Posts Part 11 and GLPs
            		Sunhorse 1 2898 05-24-07 07:15 AM
    by John
    No New Posts Grandfather clause for Legacy Systems
            		IHN1 1 2784 05-08-07 07:05 AM
    by John
    No New Posts Electronic Media Destruction
            		John 0 2660 03-22-07 07:08 AM
    by John
    No New Posts Electronic Record Destruction
            		belle 0 2624 03-16-07 04:02 AM
    by belle
    No New Posts New 21 cfr part 11 rule
            		Mobi Maniak 3 6652 03-08-07 05:31 PM
    by PaulS
    No New Posts eSubmissions to FDA
            		Orit 2 3076 02-28-07 08:52 PM
    by Orit
    No New Posts Audit Trials and Access
            		mac 1 3301 02-25-07 09:51 AM
    by John
    No New Posts White papers of interest - Very informative
            		Graham O'Keeffe 1 3550 01-18-07 11:21 AM
    by mjgregor
    No New Posts Part 11 and DB's
            		Graham O'Keeffe 1 3158 12-26-06 02:31 PM
    by arf2000
    No New Posts Access Database
            		Anonymous 3 4982 12-09-06 08:26 AM
    by Mark Khayter
    No New Posts When electronic record does not triger PART 11?
            		Anonymous 10 7324 12-09-06 08:16 AM
    by Mark Khayter
    No New Posts medical oxygen quality
            		aganany 1 2942 12-09-06 07:59 AM
    by Mark Khayter
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