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3
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Good Practices for Computerised Systems in Regulated "GxP" Environments. PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-Operation Scheme. PI 011-3 http://www.picscheme.org/publis/ recommandations/PI%20011-3%20Recommendation%20on%20Computerised%20Systems.pdf. 25 September 2007.
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6
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ISBT Guidelines for Information Security in Transfusion Medicine, Volume 91 Supplement 1 Vox Sanguinis. July 2006
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Guidance for Industry ICH Q8 Pharmaceutical Development. U.S. Department of Health and Human Services Food and Drug Administration. . May 2006
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8
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Guidance for Industry ICH Q9 Quality Risk Management.U.S. Department of Health and Human Services Food and Drug Administration. . January 2006.
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Guidance for Industry ICH Q9 Quality Risk Management.U.S. Department of Health and Human Services Food and Drug Administration. http://www.fda.gov/cder/ guidance/7153fnl.pdf. January 2006.
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Guidance for Industry ICH Q10 Pharmaceutical Quality System. U.S. Department of Health and Human Services Food and Drug Administration. . 11. Reading List April 2009.
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Guidance for Industry ICH Q10 Pharmaceutical Quality System. U.S. Department of Health and Human Services Food and Drug Administration. http://www.fda.gov/cder/guidance/8515fnl.pdf. 11. Reading List April 2009.
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10
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Medical Device Quality Systems Manual - 7. Equipment and Calibration. U.S. Food and Drug Administration - Center for Devices and Radiological Health. . January 1997
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Medical Device Quality Systems Manual - 7. Equipment and Calibration. U.S. Food and Drug Administration - Center for Devices and Radiological Health. http://www.fda.gov/cdrh/qsr/07.html. January 1997.
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11
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74049097744
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Proposed Validation Standard VS-2 Computer-Related System Validation. Barbara Mullendore, Kenneth G. Chapman. Journal of Validation Technology. Volume 7, Number 3. May 2001
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Proposed Validation Standard VS-2 Computer-Related System Validation. Barbara Mullendore, Kenneth G. Chapman. Journal of Validation Technology. Volume 7, Number 3. May 2001.
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12
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74049157239
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Risk Assessment Program Quality Assurance Plan. Environmental Management and Enrichment Facilities, Lockheed Martin Energy Systems, Inc. . November 1997.
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Risk Assessment Program Quality Assurance Plan. Environmental Management and Enrichment Facilities, Lockheed Martin Energy Systems, Inc. http://risk.lsd.ornl.gov/homepage/tm/tm117.pdf. November 1997.
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Risk Assessment Program Data Management Implementation Plan. Environmental Restoration Risk Assessment Program, Lockheed Martin Energy Systems, Inc. . November 1997.
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Risk Assessment Program Data Management Implementation Plan. Environmental Restoration Risk Assessment Program, Lockheed Martin Energy Systems, Inc. http://risk.lsd.ornl.gov/homepage/tm/tm232.pdf. November 1997.
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Medical Device Quality Systems Manual - 4. Process Validation. U.S. Food and Drug Administration - Center for Devices and Radiological Health. 1997.
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Medical Device Quality Systems Manual - 4. Process Validation. U.S. Food and Drug Administration - Center for Devices and Radiological Health. http://www.fda.gov/cdrh/qsr/04valid.html.January 1997.
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15
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Medical Device Quality Systems Manual - 5. Personnel and Training. U.S. Food and Drug Administration - Center for Devices and Radiological Health. . January 1997.
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Medical Device Quality Systems Manual - 5. Personnel and Training. U.S. Food and Drug Administration - Center for Devices and Radiological Health. http://www.fda.gov/cdrh/qsr/05prsnl.html. January 1997.
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Medical Device Quality Systems Manual - 15. Complaints. U.S. Food and Drug Administration - Center for Devices and Radiological Health. 1997.
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Medical Device Quality Systems Manual - 15. Complaints. U.S. Food and Drug Administration - Center for Devices and Radiological Health. http://www.fda.gov/cdrh/qsr/15compl.html.January 1997.
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GLP Consensus Document the Application of the Principles of GLP to Computerised Systems, Environment Monograph N°. 116. - OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring - N° 10. Organisation for Economic Co-Operation and Development. . 1995.
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GLP Consensus Document the Application of the Principles of GLP to Computerised Systems, Environment Monograph N°. 116. - OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring - N° 10. Organisation for Economic Co-Operation and Development. http://www.olis.oecd. org/olis/1995doc.nsf/LinkTo/NT00000C06/$FILE/ENE51434.PDF. 1995.
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PIC/S GMP Guide to Good Manufacturing Practice for Medicinal Products Part II. PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-Operation Scheme. . January 2009.
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PIC/S GMP Guide to Good Manufacturing Practice for Medicinal Products Part II. PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-Operation Scheme. http://www.picscheme.org/publis/guides/PE-009-8- GMP-Guide%20-Part-II-Basic-Requirements-for-API.pdf. January 2009.
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ISO/IEC 14598-4:1999 Information technology. Software production evaluation. Process for acquirers. International Organization for Standardization
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ISO/IEC 14598-4:1999 Information technology. Software production evaluation. Process for acquirers. International Organization for Standardization. 1999.
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(1999)
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20
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GAMP® Good Practice Guide: Calibration Management. ISPE. Dec 2001
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GAMP® Good Practice Guide: Calibration Management. ISPE. Dec 2001.
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21
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Good Practice and Compliance for Electronic Records and Signatures Part 1 - Good Electronic Records Management (GERM). ISPE, PDA. 2002.
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Good Practice and Compliance for Electronic Records and Signatures Part 1 - Good Electronic Records Management (GERM). ISPE, PDA. 2002.
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Good Practice and Compliance for Electronic Records and Signatures Part 2 - Complying with 21 CFR Part 11 Electronic Records and Electronic Signatures. ISPE, PDA.
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Good Practice and Compliance for Electronic Records and Signatures Part 2 - Complying with 21 CFR Part 11 Electronic Records and Electronic Signatures. ISPE, PDA. 2001.
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Guidance for FDA Reviewers and Industry - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. U.S. Department of Health and Human Services Food and Drug Administration - Center for Devices and Radiological Health. . May 2005.
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Guidance for FDA Reviewers and Industry - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. U.S. Department of Health and Human Services Food and Drug Administration - Center for Devices and Radiological Health. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm. May 2005.
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Glossary of Computerized System and Software Development Terminology. Inspection references: Inspection Guides. U.S. Food and Drug Administration Office of Regulatory Affairs. . August 1995
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Glossary of Computerized System and Software Development Terminology. Inspection references: Inspection Guides. U.S. Food and Drug Administration Office of Regulatory Affairs. http://www.fda.gov/ICECI/Inspections/ InspectionGuides/ucm074875.htm. August 1995.
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25
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GLP - Guidelines for the Validation of Computerised Systems. Working group Information Technology (AGIT). Version 2. . December 2007.
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GLP - Guidelines for the Validation of Computerised Systems. Working group Information Technology (AGIT). Version 2. http://www.bag.admin.ch/themen/ chemikalien/00253/00539/03300/index.html?lang=en. December 2007.
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Validation in Blood Establishments and Transfusion Services. AABB Press. 1996.
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Validation in Blood Establishments and Transfusion Services. AABB Press. 1996.
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ISO 9001:2008 Quality management systems. Requirements. International Organization for Standardization. November 2008
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ISO 9001:2008 Quality management systems. Requirements. International Organization for Standardization. November 2008.
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Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software. U.S. Department of Health and Human Services Food and Drug Administration - Center for Devices and Radiological Health. . January 2005
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Guidance for Industry Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software. U.S. Department of Health and Human Services Food and Drug Administration - Center for Devices and Radiological Health. http://www.fda.gov/cdrh/comp/guidance/1553.html. January 2005
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29
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74049129676
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GAMP® Good Practice Guide: Electronic Data Archiving. ISPE. July 2007
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GAMP® Good Practice Guide: Electronic Data Archiving. ISPE. July 2007
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30
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74049114838
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GAMP® Good Practice Guide: Testing of GxP Systems. ISPE. Dec 2005
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GAMP® Good Practice Guide: Testing of GxP Systems. ISPE. Dec 2005
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31
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74049159309
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GAMP® Good Practice Guide: IT Infrastructure Control and Compliance. ISPE. Sept 2005
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GAMP® Good Practice Guide: IT Infrastructure Control and Compliance. ISPE. Sept 2005
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32
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GAMP® Good Practice Guide: Validation of Laboratory Computerized Systems. ISPE. April 2005. ISBN 1-931879-39-7.
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GAMP® Good Practice Guide: Validation of Laboratory Computerized Systems. ISPE. April 2005. ISBN 1-931879-39-7.
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33
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GAMP® Good Practice Guide: Risk-Based Approach to Electronic Records and Signatures. ISPE. Feb 2005
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GAMP® Good Practice Guide: Risk-Based Approach to Electronic Records and Signatures. ISPE. Feb 2005
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34
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Guide to the Preparation, Use and Quality Assurance of Blood Components 14th Edition. CoE. 2008.
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Guide to the Preparation, Use and Quality Assurance of Blood Components 14th Edition. CoE. 2008.
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