FDA Software Validation軟件驗(yàn)證指南

1、General Principles of SoftwareValidation; Final Guidance for Industry and FDA Staff軟件驗(yàn)證的基本原理；企業(yè)和FDA人員的最終指導(dǎo)準(zhǔn)則Document issued on發(fā)布日期: January 11, 2002This document supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.本文件取代之前的草案“1997年6月9日的1.1版軟件驗(yàn)證的基本

2、原理 ”U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and ResearchPreface前言Public Comment 公眾評(píng)論（意見/問題）Comments and suggestions may be submitted at any time for Agency consideration to DocketsManagement

3、Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be

4、acted upon by the Agency until the document is next revised or updated.For questions regarding the use or interpretation of this guidance which involve the Center for Devices and Radiological Health (CDRH), contact John F. Murray at (301) 594-4659 or ema HYPERLINK mailto:jfm il jfmFor questions rega

5、rding the use or interpretation of this guidance which involve the Center for Biologics Evaluation and Research (CBER) contact Jerome Davis at (301) 827-6220 or email HYPERLINK mailto:davis davis.（略）Additional Copies 額外話題CDRH Additional copies are available from the Internet at: HYPERLINK /MedicalDe

6、vices/DeviceRegulationandGuidance/GuidanceDocuments/UCM085281.htm /MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM085281.htm. You may also send an e-mail request to HYPERLINK mailto:dsmica dsmica to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to

7、receive a hard copy. Please use the document number (938) to identify the guidance you are requesting.CBER Additional copies are available from the Internet at: HYPERLINK /cber/guidelines.htm /cber/guidelines.htm, bywriting to CBER, Office of Communication, Training, and Manufacturers Assistance (HF

8、M40), 1401 Rockville Pike, Rockville, Maryland 20852-1448, or by telephone request at 1800-835-5709 or 301-827-1800. （略）Table of Contents目錄 HYPERLINK l _bookmark0 SECTION 1. PURPOSE 第 1 部分 目的4 HYPERLINK l _bookmark1 SECTION 2. SCOPE 第 2 部分 范圍4 HYPERLINK l _bookmark2 APPLICABILITY 適用范圍5 HYPERLINK l _

9、bookmark3 AUDIENCE 公眾5 HYPERLINK l _bookmark4 THE LEAST BURDENSOME APPROACH 最簡(jiǎn)便的方法5 HYPERLINK l _bookmark5 REGULATORY REQUIREMENTS FOR SOFTWARE VALIDATION 軟件驗(yàn)證的監(jiān)管要求6 HYPERLINK l _bookmark6 QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS 質(zhì)量系統(tǒng)法規(guī) VS 上市前申請(qǐng)7 HYPERLINK l _bookmark7 SECTION 3. CONTEXT

10、FOR SOFTWARE VALIDATION 軟件驗(yàn)證的背景8 HYPERLINK l _bookmark8 DEFINITIONS AND TERMINOLOGY 定義和術(shù)語8 HYPERLINK l _bookmark9 Requirements and Specifications 法規(guī)要求和標(biāo)準(zhǔn)規(guī)范8 HYPERLINK l _bookmark10 Verification and Validation 軟件確認(rèn)和驗(yàn)證9 HYPERLINK l _bookmark11 IQ/OQ/PQ10 HYPERLINK l _bookmark12 SOFTWARE DEVELOPMENT AS

11、 PART OF SYSTEM DESIGN 軟件設(shè)計(jì)-軟件開發(fā)11 HYPERLINK l _bookmark13 SOFTWARE IS DIFFERENT FROM HARDWARE 軟件不同于硬件11 HYPERLINK l _bookmark14 BENEFITS OF SOFTWARE VALIDATION 軟件驗(yàn)證的益處13 HYPERLINK l _bookmark15 3.5 DESIGN REVIEW 設(shè)計(jì)評(píng)審13 HYPERLINK l _bookmark16 SECTION 4. PRINCIPLES OF SOFTWARE VALIDATION 軟件驗(yàn)證的法則14 H

12、YPERLINK l _bookmark17 REQUIREMENTS 法規(guī)要求14 HYPERLINK l _bookmark18 DEFECT PREVENTION 缺陷預(yù)防14 HYPERLINK l _bookmark19 TIME AND EFFORT 時(shí)間和嘗試14 HYPERLINK l _bookmark20 SOFTWARE LIFE CYCLE 軟件生命周期15 HYPERLINK l _bookmark21 PLANS 計(jì)劃15 HYPERLINK l _bookmark22 PROCEDURES 規(guī)程15 HYPERLINK l _bookmark23 SOFTWARE

13、 VALIDATION AFTER A CHANGE 變更后的軟件驗(yàn)證15 HYPERLINK l _bookmark24 VALIDATION COVERAGE 驗(yàn)證范圍15 HYPERLINK l _bookmark25 INDEPENDENCE OF REVIEW 獨(dú)立評(píng)審16 HYPERLINK l _bookmark26 FLEXIBILITY AND RESPONSIBILITY 靈活性和責(zé)任16 HYPERLINK l _bookmark27 SECTION 5. ACTIVITIES AND TASKS 活動(dòng)和任務(wù)17 HYPERLINK l _bookmark28 SOFTW

14、ARE LIFE CYCLE ACTIVITIES 軟件生命周期活動(dòng)17 HYPERLINK l _bookmark29 TYPICAL TASKS SUPPORTING VALIDATION 典型的任務(wù)輔助性驗(yàn)證17 HYPERLINK l _bookmark30 Quality Planning 質(zhì)量計(jì)劃18 HYPERLINK l _bookmark31 Requirements 需求19 HYPERLINK l _bookmark32 Design 設(shè)計(jì)21 HYPERLINK l _bookmark33 Construction or Coding23 HYPERLINK l _bo

15、okmark34 Testing by the Software Developer 軟件開發(fā)者執(zhí)行的測(cè)試25 HYPERLINK l _bookmark35 User Site Testing 用戶現(xiàn)場(chǎng)測(cè)試31 HYPERLINK l _bookmark36 Maintenance and Software Changes 維護(hù)和軟件變更33 HYPERLINK l _bookmark37 SECTION 6. VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE 自動(dòng)化 HYPERLINK l _book

16、mark37 過程驗(yàn)證設(shè)備和質(zhì)量系統(tǒng)軟件34 HYPERLINK l _bookmark38 HOW MUCH VALIDATION EVIDENCE IS NEEDED? 需要多少驗(yàn)證依據(jù)36 HYPERLINK l _bookmark39 DEFINED USER REQUIREMENTS 定義用戶需求37 HYPERLINK l _bookmark40 VALIDATION OF OFF-THE-SHELF SOFTWARE AND AUTOMATED EQUIPMENT 成品軟件和自動(dòng)設(shè)備的驗(yàn)證38General Principles of Software Validation軟件驗(yàn)

17、證的一般原則This document is intended to provide guidance. It represents the Agencys current thinking on this topic.It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approa

18、ch satisfies the requirements of the applicable statutes and regulations.SECTION 1. PURPOSE 第 1 部分 目的This guidance outlines general validation principles that the Food and Drug Administration (FDA)considers to be applicable to the validation of medical device software or the validation of software u

19、sed to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997. 本指導(dǎo)概括了FDA認(rèn)為適用于醫(yī)療器械軟件驗(yàn)證，或用于設(shè)計(jì)、開發(fā)，或生產(chǎn)醫(yī)療器械的軟件驗(yàn)證的一般驗(yàn)證原則。SECTION 2. SCOPE 第 2 部分 范圍This guidance de

20、scribes how certain provisions of the medical device Quality System regulation apply tosoftware and the agencys current approach to evaluating a software validation system. For example, this document lists elements that are acceptable to the FDA for the validation of software; however, it does not l

21、ist all of the activities and tasks that must, in all instances, be used to comply with the law.本指導(dǎo)描述了醫(yī)療器械質(zhì)量系統(tǒng)法規(guī)的某些條款如何應(yīng)用到軟件，以及FDA評(píng)價(jià)一個(gè)軟件驗(yàn)證系統(tǒng)的現(xiàn)行方法。例如，本文列出了FDA對(duì)于軟件驗(yàn)證的可接受元素；但是，并未列出在一切情況下必須遵循法律的所有活動(dòng)和任務(wù)。The scope of this guidance is somewhat broader than the scope of validation in the strictest definitio

22、n of that term. Planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering discussed in this guidance are important activities that together help to support a final conclusion that software is validated.嚴(yán)格上講，本指導(dǎo)的應(yīng)用范圍比驗(yàn)證的范圍更廣泛一些。計(jì)劃、確認(rèn)、

23、測(cè)試、追溯性、配置管理及本指導(dǎo)中討論的良好軟件工程的許多其他方面是重要的活動(dòng)，它們有助于支持一個(gè)最終結(jié)論-軟件是已驗(yàn)證過的。This guidance recommends an integration of software life cycle management and risk management activities. Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine

24、the specific approach, the combination of techniques to be used, and the level of effort to be applied. While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throug

25、hout the entire software life cycle.本指導(dǎo)建議將軟件生命周期管理和風(fēng)險(xiǎn)管理活動(dòng)進(jìn)行整合。根據(jù)預(yù)期用途和與開發(fā)的軟件相關(guān)聯(lián)的安全風(fēng)險(xiǎn)，軟件開發(fā)人員應(yīng)確定特定方法，使用的多個(gè)技術(shù)的組合，以及應(yīng)用嘗試程度。雖然本指導(dǎo)未推薦任何特定生命周期模式，或任何特定技術(shù)或方法，但建議整個(gè)軟件生命周期需進(jìn)行軟件驗(yàn)證和確認(rèn)活動(dòng)。Where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) the software develo

26、per may not be directly responsible for compliance with FDA regulations.若軟件由某人而非器械生產(chǎn)商開發(fā)，如成品組件軟件，這個(gè)軟件開發(fā)者可能不直接負(fù)責(zé)FDA法規(guī)的符合性。In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developers activities and determin

27、e what additional efforts are needed to establish that the software is validated for the device manufacturers intended use.在這種情況下，負(fù)責(zé)合規(guī)的一方（即器械生產(chǎn)商）需要評(píng)價(jià)成品組件軟件開發(fā)者活動(dòng)的充分性，并確定是否需要其他嘗試來證明軟件已經(jīng)驗(yàn)證過，并符合器械生產(chǎn)商的預(yù)期用途。APPLICABILITY 適用范圍This guidance applies to:本指導(dǎo)適用于：Software used as a component, part, or accessory

28、of a medical device;用作一個(gè)醫(yī)療器械的一個(gè)組件、部件，或配件的軟件；Software that is itself a medical device (e.g., blood establishment software);本身即是一個(gè)醫(yī)療器械的軟件（例如，血制品企業(yè)軟件）Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and器械生產(chǎn)中使用的軟件（例如，生產(chǎn)設(shè)備中使用的可編程邏輯控制器）；及Softwa

29、re used in implementation of the device manufacturers quality system (e.g., software that records and maintains the device history record).用作器械生產(chǎn)商質(zhì)量系統(tǒng)的軟件（例如，記錄和維護(hù)器械歷史記錄的軟件）。This document is based on generally recognized software validation principles and, therefore, can be applied to any software. F

30、or FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy. This document does not specifically identify which software is or is not

31、 regulated. 普遍認(rèn)為，本文件是基于軟件驗(yàn)證的原則，因此，適用于任何軟件。從FDA角度看，按照食品藥品化妝品法第201(h)條和現(xiàn)行FDA軟件和監(jiān)管方針的規(guī)定，本指導(dǎo)適用于任何與管制醫(yī)療器械相關(guān)的軟件。本文件并未特地說明軟件是否被監(jiān)管。AUDIENCE 公 眾This guidance provides useful information and recommendations to the following individuals:本指導(dǎo)為下列個(gè)人提供了有價(jià)值的信息和建議：Persons subject to the medical device Quality System

32、regulation受醫(yī)療器械質(zhì)量系統(tǒng)監(jiān)管的人員Persons responsible for the design, development, or production of medical device software負(fù)責(zé)醫(yī)療器械軟件的設(shè)計(jì)、開發(fā)或生產(chǎn)的人員Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or s

33、oftware tools used to implement the quality system itself負(fù)責(zé)自動(dòng)工具或軟件工具的設(shè)計(jì)、開發(fā)、生產(chǎn)或采購的人員，自動(dòng)工具是用于醫(yī)療器械的設(shè)計(jì)、開發(fā)或制造，軟件工具用于質(zhì)量系統(tǒng)本身FDA Investigators FDA 調(diào)研人員FDA Compliance Officers FDA 合規(guī)辦公室FDA Scientific Reviewers FDA 科學(xué)評(píng)審員THE LEAST BURDENSOME APPROACH 最簡(jiǎn)便的方法We believe we should consider the least burdensome app

34、roach in all areas of medical device regulation. Thisguidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less bu

35、rdensome, please contact us so we can consider your point of view.You may send your written comments to the contact person listed in the preface to this guidance or to theCDRH Ombudsman. Comprehensive information on CDRHs Ombudsman, including ways to contact him, can be found on the Internet at:我們認(rèn)為

36、我們應(yīng)考慮醫(yī)療器械法規(guī)所有領(lǐng)域中的最簡(jiǎn)便的方法。本指導(dǎo)反映了我們對(duì)相關(guān)科學(xué)和法律要求的仔細(xì)評(píng)審，以及我們認(rèn)為的對(duì)于你來說符合那些要求的最簡(jiǎn)便的方式。然而，如果你認(rèn)為一個(gè)替代的方法可能更好，請(qǐng)與我們聯(lián)系，我們可給予考慮。你可發(fā)送書面評(píng)論至本指導(dǎo)封面列出的聯(lián)系人或至CDRH的調(diào)查專員。更多關(guān)于CDRH調(diào)查專員的信息，包括聯(lián)系方式，詳見下面鏈接： HYPERLINK /cdrh/resolvingdisputes/ombudsman.html /cdrh/resolvingdisputes/ombudsman.html.REGULATORY REQUIREMENTS FOR SOFTWARE VAL

37、IDATION 軟件驗(yàn)證的監(jiān)管要求The FDAs analysis of 3140 medical device recalls conducted between 1992 and 1998 reveals that242 ofthem (7.7%) are attributable to software failures. Of those software related recalls, 192 (or79%) were caused by software defects that were introduced when changes were made to the sof

38、tware after its initial production and distribution. Software validation and other related good software engineering practices discussed in this guidance are a principal means of avoiding such defects and resultant recalls.從FDA對(duì)19921998年間認(rèn)證的3140例醫(yī)療器械的召回事件的原因回顧分析看出，有242例是因軟件失效導(dǎo)致，而其中192例是因?yàn)閷?duì)軟件最初版本進(jìn)行修改

39、后，導(dǎo)致軟件系統(tǒng)出現(xiàn)缺陷并造成軟件系統(tǒng)失效。軟件驗(yàn)證及其相關(guān)良好軟件工程開發(fā)規(guī)范（本指導(dǎo)討論的）是避免此類缺陷及隨后導(dǎo)致的召回事件的一個(gè)最重要的方式。Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1996 and took effect on June 1, 1997. (See Title 21 Code of Federal Regulations (CFR) Part 820,

40、and 61 Federal Register (FR) 52602, respectively.) Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturers quality system.軟件驗(yàn)證是質(zhì)量體系法

41、規(guī)的要求，即1996年10月7日發(fā)表在FR（聯(lián)合公報(bào)）上，并于1997年6月1日生效的法規(guī)（分別參見21CFR820部分和FR61卷52602）。驗(yàn)證需求的應(yīng)用范圍，包括用作醫(yī)療器械組件的軟件，本身即是一個(gè)醫(yī)療器械的軟件和生產(chǎn)設(shè)備使用的或在器械生產(chǎn)商質(zhì)量系統(tǒng)中執(zhí)行的軟件。Unless specifically exempted in a classification regulation, any medical device software product developed after June 1, 1997, regardless of its device class, is su

42、bject to applicable design control provisions. (See of 21 CFR 820.30.) This requirement includes the completion of current development projects, all new development projects, and all changes made to existing medical device software. Specific requirements for validation of device software are found i

43、n21 CFR 820.30(g). Other design controls, such as planning, input, verification, and reviews, are required for medical device software. (See 21 CFR 820.30.) The corresponding documented results from these activities can provide additional support for a conclusion that medical device software is vali

44、dated.除非分類法規(guī)中有特殊豁免，任何1997年6月1日后研發(fā)的醫(yī)療器械軟件產(chǎn)品，不管其類別，應(yīng)與設(shè)計(jì)控制條款相適用（參見21CFR820.30. ）這個(gè)要求包括現(xiàn)有研發(fā)項(xiàng)目，所有新研發(fā)項(xiàng)目及所有目前醫(yī)療器械軟件的變更的完成。醫(yī)療器械軟件驗(yàn)證的特殊需要參見21 CFR 820.30(g) 。其他設(shè)計(jì)控制，如計(jì)劃、輸入、確認(rèn)和審核，均是醫(yī)療器械軟件必須具有的（參見21 CFR 820.30 ）。來自這些活動(dòng)的相應(yīng)記錄的結(jié)果可為醫(yī)療器械軟件驗(yàn)證的結(jié)論提供額外支持。Any software used to automate any part of the device production pr

45、ocess or any part of the quality systemmust be validated for its intended use, as required by 21 CFR 820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate

46、 any other aspect of the quality system.按照21 CFR 820.70(i) ，用于控制器械生產(chǎn)工藝的或質(zhì)量系統(tǒng)的任何部分的所有軟件必須驗(yàn)證以符合預(yù)期用途，這項(xiàng)規(guī)定適用于以下用途的軟件，如自動(dòng)控制器械的設(shè)計(jì)、檢測(cè)、組件驗(yàn)收、生產(chǎn)、貼標(biāo)、包裝、銷售、投訴處理或質(zhì)量系統(tǒng)任何其他部分的自動(dòng)化操作。In addition, computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are also sub

47、ject to the validation requirements. (See 21 CFR 11.10(a).) Such computersystems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.另外，用于創(chuàng)建、修改及維護(hù)電子記錄和管理電子簽名的計(jì)算機(jī)系統(tǒng)也應(yīng)進(jìn)行驗(yàn)證(見 21 CFR11.10(a) 。這些計(jì)算機(jī)系統(tǒng)必須驗(yàn)證，以確保準(zhǔn)確性、可靠性，始終符

48、合預(yù)期性能，識(shí)別無效或變更記錄的能力。Software for the above applications may be developed in-house or under contract. However, software is frequently purchased off-the-shelf for a particular intended use. All production and/or quality system software, even if purchased off-the-shelf, should have documented requiremen

49、ts that fully define its intended use, and information against which testing results and other evidence can be compared, to show that the software is validated for its intended use.上述應(yīng)用程序軟件可能由內(nèi)部或合同商開發(fā)。然而，由于特殊預(yù)期用途，經(jīng)常購買成品軟件。所有生產(chǎn)和/或質(zhì)量系統(tǒng)軟件，即便是購買的軟件，也應(yīng)備有完全明確其預(yù)期用途的要求。The use of off-the-shelf software in a

50、utomated medical devices and in automated manufacturing and quality system operations is increasing. Off-the-shelf software may have many capabilities, only a few of which are needed by the device manufacturer. Device manufacturers are responsible for the adequacy of the software used in their devic

51、es, and used to produce devices. When device manufacturers purchase off-the-shelf software, they must ensure that it will perform as intended in their chosen application. For off-the-shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6.3 of this

52、 document. For device software, additional useful information HYPERLINK /cdrh/ode/1252.html may be found in FDAs Guidance for Industry, HYPERLINK /cdrh/ode/1252.html FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices.自動(dòng)醫(yī)療設(shè)備和自動(dòng)生產(chǎn)/質(zhì)量系統(tǒng)操作用成品軟件的使用日益增加。成品軟件可有許多性能，但器械生產(chǎn)商僅需要其中的幾

53、個(gè)。器械生產(chǎn)商負(fù)責(zé)其器械使用的軟件是否適當(dāng)。當(dāng)器械生產(chǎn)商購買“成品” 軟件時(shí)，他們必須確保軟件將按照選用的應(yīng)用程序運(yùn)行。對(duì)于生產(chǎn)或質(zhì)量系統(tǒng)使用的成品軟件，也適用于本文第6.3部分的指導(dǎo)。對(duì)于器械軟件，其他有用的信息可參見FDA的工業(yè)指導(dǎo)：FDA評(píng)審人員， 及醫(yī)療器械用成品軟件的合規(guī)。QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS 質(zhì)量系統(tǒng)法規(guī)VS 上市前申請(qǐng)This document addresses Quality System regulation issues that involve the implementation of

54、softwarevalidation. It provides guidance for the management and control of the software validation process. The management and control of the software validation process should not be confused with any other validation requirements, such as process validation for an automated manufacturing process.本

55、文所述質(zhì)量系統(tǒng)法規(guī)問題包括軟件驗(yàn)證的實(shí)施，并為軟件驗(yàn)證過程的管理和控制提供指導(dǎo)。軟件驗(yàn)證過程的管理和控制不應(yīng)與任何其他驗(yàn)證要求相混淆，例如一個(gè)自動(dòng)生產(chǎn)過程的工藝驗(yàn)證。Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre-market submissions to FDA. This document does not cover any specific

56、safety or efficacy issues related to software validation. Design issues and documentation requirements for pre-market submissions of regulated software are not addressed by this document. Specific issues related to safety and efficacy, and the documentation required in pre-market submissions, should

57、 be addressed to the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) or to the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER). See the references in Appendix A for applicable FDA guidance documents for pre-market submissi

58、ons.器械生產(chǎn)商可以使用符合質(zhì)量系統(tǒng)和設(shè)計(jì)控制要求的相同的規(guī)程和記錄，也可使用符合上市前遞交的申請(qǐng)（FDA）。本文件不包括與軟件驗(yàn)證有關(guān)的所有特殊安全性或有效性問題。本文沒有敘述管制軟件上市前申請(qǐng)的設(shè)計(jì)問題和文件要求。與安全性或有效性有關(guān)的特殊問題，以及上市前申請(qǐng)需要的文件，應(yīng)寫信給CDRH中心的ODE辦公室或CBER的血液研究與評(píng)審辦公室。FDA上市前申請(qǐng)指導(dǎo)文件參見附件A。SECTION 3. CONTEXT FOR SOFTWARE VALIDATION 軟件驗(yàn)證的背景Many people have asked for specific guidance on what FDA ex

59、pects them to do to ensure compliance withthe Quality System regulation with regard to software validation. Information on software validation presented in this document is not new. Validation of software, using the principles and tasks listed in Sections 4 and 5, has been conducted in many segments

60、 of the software industry for well over 20 years.許多人已在尋求關(guān)于FDA期待他們保證遵循與軟件驗(yàn)證相關(guān)的質(zhì)量系統(tǒng)法規(guī)的特殊指導(dǎo)。本文展現(xiàn)的軟件驗(yàn)證信息不是新的。使用第4、5部分列出的原則和任務(wù)的軟件驗(yàn)證已在軟件產(chǎn)業(yè)的許多領(lǐng)域應(yīng)用20多年了。Due to the great variety of medical devices, processes, and manufacturing facilities, it is not possible to state in one document all of the specific valid