FDA Software Validation软件验证指南 General Principles of Software Validation; Final Guidance for Industry and FDA Staff 软件验证的基本原理；企业和FDA人员的最终指导准则 Document issued on发布日期: January 11, 2002 This document supersedes the draft document, "General Principles of Software Validation, ...
Software validation methods The FDA’s guidance and requirements can seem overwhelming — but the task of following them can be simplified to not only stay compliant, but to help your business, as well. Most validation projects follow the same basic format, known as the “4Q Lifecycle Model...
1、General Principles of SoftwareValidation; Final Guidance for Industry and FDA Staff软件验证的基本原理;企业和FDA人员的最终指导准则Document issued on发布日期: January 11, 2002This document supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.本...
FDA Software Validation软件验证指南
This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997. 本指导概 括了FDA认为适用于医疗器械软件验证,或用于设计、开发,或生产医疗器械的软件验证的一般验 证原则。 SECTION 2. SCOPE 第第 2 部分部分 范围范围...
Keatley, K.L.: A review of the FDA draft guidance document for software validation: guid- ance for industry. Qual. Assur. 7(1), 49-55 (1999)Keatley, K.L.: A review of the fda draft guidance document for software validation: Guidance for industry. Qual. Assur. 7(1), 49-55 (1999...
See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download. 请参阅FDA的指导性文件《工艺验证:一般原则和惯例》,以获取FDA关于工艺验证适当...
FDA Software Validation软件验证指南.pdf,General Principles of Software Validation; Final Guidance for Industry and FDA Staff 软件验证的基本原理; 企业和FDA人员的最终指导准则 Document issued on发布日期: January 11, 2002 This document supersedes the draft
FDA_软件认证指南_Software_Validation 下载积分:600 内容提示: General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document issued on: January 11, 2002 This document supersedes the draft document, "General Principles of Software Validation, Version 1. 1, dated June 9...
validationsoftware验证fda软件指南 GeneralPrinciplesofSoftwareValidation;FinalGuidanceforIndustryandFDAStaff软件验证的基本原理;企业和FDA人员的最终指导准则Documentissuedon发布日期:January11,2002Thisdocumentsupersedesthedraftdocument,"GeneralPrinciplesofSoftwareValidation,Version1.1,datedJune9,1997.本文件取代之前的草案“19...