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美国FDA《血液机构计算机系统用户确认指引》之解读

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摘要 血液机构计算机系统的确认工作既是血液质量管理工作的重点，又是难点。为了帮助血液机构制定与实施血液机构计算机系统确认程序，确保其符合软件确认、质量保证和软件工程质量管理的公认原则，美国FDA于2007年10月发布了行业指引《血液机构计算机系统用户珩认指引（草案）》，2013年4月发布了该指引的正式文件。诙指引给出了血液机构如何在将要上线运行的环境中对计算机系统实施确认的工作框架和要点，具有非常实用的参考和借鉴价值。现将其主要内容介绍如下。
作者 兰长旺 郭永建
机构地区 福建省血液中心
出处 《中国输血杂志》 CAS CSCD 北大核心 2014年第1期108-111,共4页 Chinese Journal of Blood Transfusion
关键词 计算机系统 确认 血液机构 指引 血液质量管理
分类号 R457.1 [医药卫生—治疗学] TP315 [自动化与计算机技术—计算机软件与理论]
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参考文献9

  • 1U.S.Department of Health and Human Services,Food and Drug Administration,Center for Biologics Evaluation and Research. Guidance for industry:bloed establishment computer system validation in the user's Facility[OL].http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm,2013.
  • 2U.S.Department of Health and Human Services,Food and Drug Administration,Center for Devices and Radiological Health Office of Device Evaluation,Office of in vitro Diagnostics,Center for Biologics Evaluation and Research,Office of Blood Research and Review. Guidance for industry and FDA Staff:Guidance for the Content of premarket submissions for software contained in medical devices[OL].http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.him,2013.
  • 3U.S.Department Of Health and Human Services,Food and Drug Administration. 510 (k) blood establishment computer software[OL].http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProduets/SubstantiallyEquivalent510kDeviceInformation/ucm134987.htm,2013.
  • 4中华人民共和国卫生部.关于印发《血站质量管理规范》的通知(卫医发[2006]167号)[Z],2006.
  • 5U.S.Department Of Health and Human Services,Food and Drug Administration,Center for Devices and Radiological Health,Center for Biologics Evaluation and Research. General principles of software validation,final guidance for industry and FDA staff[OL].http://www.fda.gov/MedicalDevices/Device-RegulationandGuidance/GuidanceDceuments/ucm085281.htm,2013.
  • 6邹峥嵘,励修楣,高瑜,程远.血液管理信息系统确认标准的初步探索[J].中国输血杂志,2009,22(7):589-590. 被引量：6
  • 7上海市质量技术监督局.血液信息管理系统确认规范[S],2012.
  • 8林洪铿,兰长旺,王同显,郭永建.ISBT关于血液机构自动化系统确认指南主要内容介绍[J].中国输血杂志,2010,23(5):406-410. 被引量：5
  • 9林洪铿,兰长旺,王同显,郭永建.ISBT关于血液机构自动化系统确认指南主要内容介绍(续)[J].中国输血杂志,2010,23(6):484-489. 被引量：4

二级参考文献14

  • 1中华人民共和国卫生部.血站质量管理规范.卫医发[2006]167号,2006-04-25.
  • 2U.S. Department of Health and Human Services-Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologies Evaluation and Re,arch. General principles of software validation; final guidance for industry and FDA staff [OL]. 2002-01-11 [2009-07-10] http://www. fda. gov/downloads/MedicalDevices/DeviceRegulatonGuidance/GuidanceDocuments/UCM-085371.pdf.
  • 3International Society of Blood Transfusion Validation task force. Guidelines for validation and maintaining the validation state of automated systems in blood banking. Vox Sang, 2003,85 (Suppl 1 ) :S1-S14.
  • 4GB/T8566-2007信息技术软件生存周期.
  • 5ISO/IEC 20000-1:2005 Information technology-Service management-Part 1 : Specification.
  • 6International Society of Blood Transfusion. ISBT guidelines for validation and maintaining the validation state of automated systems in blood banking. Version 1.1. Vox Sang 2003, 85 (Suppl 1 ) : S1- S14.
  • 7International Society for Pharmaceutical Engineering. GAMP? 5: A risk-based approach to compliant GxP computerized systems, 2008, ISBN 1-931879-61-3.
  • 8U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry ICH Q8 pharmaceutical development, 2006-05 [ 2010-05-14 ] http://www, fda. gov/downloads/RegulatoryInformation/Guidances/ucm128029, pdf.
  • 9U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry ICH Q9 quality risk management, 2006-06 [ 2010-05-14 ]. http ://www. fda. gov/downloads/ Drugs/GuidanceC omplianceRegul atorylnformafi on/Guidances/ ucm073511, pdf.
  • 10U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry ICH Q10 pharmaceutical quality system, 2009-04 [ 2010-05-14 ]. http://www, fda. gov/ downloads/Drugs/GGuidances/ucm073517. pdf.

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中国输血杂志
2014年 第1期

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