FDA Guidance Document: Computerized Systems Used In Clinical InvestigationsDrug Administration (FDA)
•FDAFinalGuidanceforIndustryandFDA Staff，2002 •GAMPGuideforValidationofAutomated SystemsVer.4 美国FDA计算机系统验证 FDAFinalGuidanceforIndustryandFDAStaff，2002 •针对行业和FDA官员的指导（非强制性）•主要内容软件验证的原则 ❖要求规格、故障预防、评估的独立性等 工作和任务 ❖验证的主要任务❖...
在检查期间,我们检查员发现的具体缺陷包括但不限于: 1. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data...
1. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data. 1.未能对计算机化系统实施充分的控制,以阻止未经授权的访问或数据修改,未能提供适当的控制以阻止数据的删除。 Your firm...
1. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data. 未对计算机化系统进行足够控制,防止未经授权访问或修改数据,无充分控制以防止数据的删除。
[2] FDA. Computerized Systems Used in Clinical Investigations [EB/OL].https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070266.pdf [3] EMEA GCP INSPECTORS WORKING GROUP .REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS [EB...
4. How should access to CGMP computer systems be restricted? 4.如何限制对CGMP计算机系统的访问? You must exercise appropriate controls to assure that changes to computerized MPCRs or other CGMP records or input of laboratory data into computerized records can be made only by authorized personnel (...
These include the FDA’s Guidance for Industry: E6 Good Clinical Practice Guidance; FDA’s Information Sheets for Institutional Review Boards and Clinical Investigators; FDA’s Guidance for Industry: Computerized Systems Used in Clinical Trials. A more comprehensive listing of useful guidances on good...
4. How should access to CGMP computer systems be restricted? 4.如何限制对CGMP计算机系统的访问? You must exercise appropriate controls to assure that changes to computerized MPCRs or other CGMP records or input of laboratory data into computerized records can be made only by authorized personnel (...
1. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.未对计算机化系统进行足够控制,防止未经授权访问或修改数据,无充分控制以防止数据的删除。