FDA行业指南 CSA计算机化系统保障指南Computer Software Assurance for Production and Quality System Software-2025（中英文）

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Computer Software Assurance for Production and Quality System Software-2025

U.S.F0OD &DRUG

ADMINISTRATION

Contains Nonbinding Recommendations

包含不具约束力的建议

Computer Software Assurance for Production and

Quality System Software

生产和质量体系软件的计算机软件保证

Guidance for Industry and Food and Drug Administration Staff

行业和 FDA 工作人员的指南

Document issued on September 24,2025.

本文件于2025 年9月24日发布。

The draft of this document was issued on September 13,2022.

本文件的草案于2022 年9月13日发布。

U.S.F0OD &DRUG

ADMINISTRATION

U.S.Department ofHealth and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

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U.S. F0OD & DRUG

ComputerSoftware Assurance for Production and Quality System Software-2025 ADMINISTRATION

Table of Contents

I. Introduction 介绍...................................................................................................................................................................

II. Background 背景............................................................................................................................................................... 4

Ⅲ. Scope 范围...........................................................................................................................................................................

IV. Definitions 定义 ................................................................................................................................................................. 6

V. Computer Software Assurance 计算机软件保证 ......................................................................................................7

A. Computer Software Assurance Risk Framework 计算机软件保证的风险框架........................................... 7

(1) Identifying the Intended Use 确定预期用途............................................................................................... 8

(2) Determining the Risk -Based Approach 确定基于风险的方法............................................................... 10

(3) Production or Quality System Software Changes 生产或质量体系软件的变更........................... 13

(4) Determining the Appropriate Assurance Activities 确定适当的保证活动...........................................14

(5) Additional Considerations for Assurance Activities 保证活动的额外考虑 ....................................... 17

(6) Establishing the Appropriate Record 建立适当的记录........................................................................... 19

B. Considerations for Electronic Records Requirements 电子记录要求的考虑............................................. 24

Appendix A. Examples 附录A.示例............................................................................................................................... 26

Example 1:Nonconformance Management System 示例1:不合格品管理系统 .......................................... 26

Example 2: Learning Management System ( LMS )示例2:学习管理系统 .....................................................29

Example 3: Business Intelligence Applications 示例3:商业智能应用............................................................. 31

Example 4: Software as a Service ( SaaS ) Product Life Cycle Management System ( PLM )示例4:软件

即服务的产品生命周期管理系统 ...........................................................................................................

Computer Software Assurance for Production and Quality System Software-2025

This guidance represents the current thinking of the Food and Drug Administration(FDA or Agency)on this

topic.It does not establish any rights for any person and is not binding on FDA or the public.You can use an

alternative approach if it satisfies the requirements of the applicable statutes and regulations.To discuss an

alternative approach,contact the FDA staff or Office responsible for this guidance as listed on the title page.

本指南代表 FDA 或机构对该主题的最新看法。它不赋予任何人任何权利，也不具有对FDA 或公众的约束力。

如果替代方法满足适用的法律法规要求，您可以采用。若要讨论替代方法，请联系本指南封面所列的FDA 工作

人员或负责该指南的办公室。

I.Introduction¹介绍1

FDA is issuing this guidance to provide recommendations on computer software assurance for computers and

automated data processing systems used as part of medical device production or the quality system.This

guidance:

FDA 发布本指南，旨在提供关于用于医疗器械生产或质量体系的计算机及自动化数据处理系统的软件保证建议。

本指南：

·Describes "computer software assurance"as a risk-based approach to establish confidence in the

automation used for production or quality systems,and identifies where additional rigor may be

appropriate;and

将“计算机软件保证”描述为一种基于风险的方法，用以建立对用于生产或质量体系的自动化的信心，

并指出可能需要更严格措施的环节；以及

· Describes various methods and testing activities that may be applied to establish computer software

assurance and provide objective evidence to fulill regulatory requirements,such as computer software

validation requirements in quality system obligations,including requirements in 21 CFR Part 820

(hereafter referred to as "Part 820").²

描述可用于建立计算机软件保证并提供客观证据以满足监管要求的各种方法和测试活动，例如：质量体

系义务中的计算机软件验证要求，包括21 CFR 第820部分(以下简称“第820 部分”)中的要求。2

This guidance supplements FDA's guidance,"General Principles of Software Validation"(hereafter referred to

as the "Software Validation guidance")except this guidance supersedes Section 6:Validation of Automated

Process Equipment and Quality System Software of the Software Validation guidance.

本指南补充 FDA 的指导文件“软件验证的一般原则”(以下简称“软件验证指南”),但本指南取代了软件验证

指南中的第6章节：自动化过程设备和质量体系软件的验证。

For the current edition of the FDA-recognized consensus standard referenced in this document,see the FDA

Recognized Consensus Standards Database.³

关于本文件所引用的FDA 认可的共识标准的最新版本，请参阅 FDA 认可的共识标准数据库。3

In general,FDA's guidance documents do not establish legally enforceable responsibilities.Instead,guidances

describe the Agency's current thinking on a topic and should be viewed only as recommendations,unless

specific regulatory or statutory requirements are cited.The use of the word should in Agency guidances means

that something is suggested or recommended,but not required.

一般而言，FDA 的指南文件不具有法律强制执行力。它们描述了机构对某一主题的当前看法，应仅作为建议，

除非明确引用了具体的法规或法律要求。指导文件中使用“应”一词，意味着建议或推荐，但不是强制性的。

1This guidance has been prepared by the Center for Devices and Radiological Health(CDRH)and the Center for Biologics

Evaluation and Research(CBER)in consultation with the Center for Drug Evaluation and Research (CDER),Ofice of

Combination Products(OCP),and Office of Inspections and Investigations(OII).

1本指南由器械和放射卫生中心 (CDRH) 和生物制品评估与研究中心 (CBER) 与药物评估与研究 (CDER)、组合产品办公室

(OCP) 和检查与调查办公室 (OII) 协商制定。

2On February 2,2024,FDA issued a final rule amending the device Quality System Regulation,21 CFR Part 820,to align more

closely with international consensus standards for devices (89 FR 7496,available at https:/www.federalregister.gov/d/2024-

01709).This final rule will take effect on February 2,2026.Once in effect,this rule will withdraw the majority of the current

requirements in Part 820,including 21 CFR 820.70,and instead incorporate by reference the 2016 edition of the International

Organization for Standardization(ISO)13485,Medical devices -Quality management systems -Requirements for regulatory

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