MARC Record from marc_columbia

LEADER: 04724cam a2200685Ii 4500
001 14697378
005 20220514232703.0
006 m o d
007 cr cnu|||unuuu
008 150402t20152015flu ob 000 0 eng d
035 $a(OCoLC)ocn906025723
035 $a(NNC)14697378
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015 $aGBB531824$2bnb
016 7 $a101659687$2DNLM
016 7 $a017097384$2Uk
019 $a908080064$a961642634$a1066617691$a1076641750
020 $a9781482243635$q(electronic bk.)
020 $a1482243636$q(electronic bk.)
020 $z9781482243628
020 $z1482243628
035 $a(OCoLC)906025723$z(OCoLC)908080064$z(OCoLC)961642634$z(OCoLC)1066617691$z(OCoLC)1076641750
037 $aTANDF_365983$bIngram Content Group
050 4 $aQA76.76.V47
060 4 $a2015 E-860
060 4 $aW 26.55.S6
072 7 $aCOM$x051230$2bisacsh
082 04 $a005.1/4$223
049 $aZCUA
100 1 $aLópez, Orlando,$eauthor.
245 10 $aEU annex 11 guide to computer validation compliance for the worldwide health agency GMP /$cOrlando López.
264 1 $aBoca Raton, FL :$bCRC Press,$c[2015]
264 4 $c©20
264 4 $c©2015
300 $a1 online resource
336 $atext$btxt$2rdacontent
337 $acomputer$bc$2rdamedia
338 $aonline resource$bcr$2rdacarrier
504 $aIncludes bibliographical references.
588 0 $aOnline resource; title from PDF title page (EBSCO, viewed April 7, 2015).
505 0 $a1. Introduction -- 2. SLC, computer validation, and annex 11 -- 3. Annex 11 principles -- 4. Risk management -- 5. Personnel -- 6. Suppliers and service providers -- 7. Validation -- 8. Data / R.D. McDowall -- 9. Accuracy checks -- 10. Data storage -- 11. Printouts -- 12. Audit trails : ensuring data integrity / R.D. McDowall -- 13. Change and configuration management -- 14. Periodic evaluation : independent review to ensure continued validation of computerized systems / R.D. McDowall -- 15. Security -- 16. Incident management -- 17. Electronic signatures : electronic signing requirements / R.D. McDowall -- 18. Batch certification and release / Bernd Renger -- 19. Business continuity -- 20. Archiving -- 21. SLC documentation -- 22. Relevant procedural controls -- 23. Maintaining the validated state in computer systems -- 24. Annex 11 and the cloud / R.D. McDowall and Yves Samson -- 25. EU GMP chapter 4 : documentation and annex 11 / Markus Roemer -- 26. Annex 11 and electronic records integrity -- 27. Annex 11 and 21 CFR part 11 : comparisons for international compliance.
520 $aThe purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. This book supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program. It details a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly. Examples from laboratory, clinical, and manufacturing computer systems are included as well as a discussion of electronic record integrity associated with stored information. Comparisons to the Annex 11 with key worldwide computer systems regulations and guidelines, including U.S. Food and Drug Administration, Canada, Australia TGA, PIC/S, and China FDA are shown. --$cEdited summary from book.
650 0 $aComputer software$xValidation.
650 0 $aComputer security.
650 12 $aMedical Informatics$xstandards
650 12 $aSoftware Validation
650 22 $aMedical Informatics$xlegislation & jurisprudence
650 22 $aRisk Management$xstandards
650 2 $aComputer Security
650 6 $aLogiciels$xValidation.
650 6 $aSécurité informatique.
650 7 $aCOMPUTERS$xSoftware Development & Engineering$xGeneral.$2bisacsh
650 7 $aComputer security.$2fast$0(OCoLC)fst00872484
650 7 $aComputer software$xValidation.$2fast$0(OCoLC)fst00872602
655 0 $aElectronic books.
655 4 $aElectronic books.
776 08 $iPrint version:$aLopez, Orlando.$tEU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP.$dHoboken : CRC Press, ©2015$z9781482243628
830 0 $aOnline access with DDA: Askews (Medicine)
856 40 $uhttp://www.columbia.edu/cgi-bin/cul/resolve?clio14697378$zTaylor & Francis eBooks
852 8 $blweb$hEBOOKS