没有合适的资源?快使用搜索试试~ 我知道了~
FDA软件认证指南SoftwareValidation.pdf
1.该资源内容由用户上传,如若侵权请联系客服进行举报
2.虚拟产品一经售出概不退款(资源遇到问题,请及时私信上传者)
2.虚拟产品一经售出概不退款(资源遇到问题,请及时私信上传者)
版权申诉
0 下载量 15 浏览量
2021-11-10
01:29:17
上传
评论
收藏 357KB PDF 举报
温馨提示
试读
47页
FDA软件认证指南SoftwareValidation.pdf
资源详情
资源评论
资源推荐
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, 1997.
Preface
Public Comment
U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
Page 1 of 47General Principles of Software Validation; Final Guidance for Indust...
2/16/2002http://www.fda.gov/cdrh/comp/guidance/938.html
Comments and suggestions may be submitted at any time for Agency consideration to
Dockets Management 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 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
For questions regarding the use or interpretation of this guidance which involve
the Center for Biologics Evaluation and Research (CBER) contact Jerome Davis at
Additional Copies
CDRH
Additional copies are available from the Internet at:
http://www.fda.gov/cdrh/comp/guidance/938.pdf or via CDRH Facts-On-Demand. In order
to receive this document via your fax machine, call the CDRH Facts-On-Demand system
at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt, press 1 to order a document. Enter the document
number 938 followed by the pound sign (#). Follow the remaining voice prompts to
complete your request.
CBER
Additional copies are available from the Internet at:
http://www.fda.gov/cber/guidelines.htm , by writing to CBER, Office of
Communication, Training, and Manufacturers' Assistance (HFM-40), 1401 Rockville
Pike, Rockville, Maryland 20852-1448, or by telephone request at 1-800-835-5709 or
301-827-1800.
Table of Contents
SECTION 1. PURPOSE
SECTION 2. SCOPE
2.1. Applicability
2.2. Audience
Page 2 of 47General Principles of Software Validation; Final Guidance for Indust...
2/16/2002http://www.fda.gov/cdrh/comp/guidance/938.html
2.3. THE LEAST BURDENSOME APPROACH
2.4. Regulatory Requirements for Software Validation
2.4. Quality System Regulation vs Pre-Market Submissions
SECTION 3. CONTEXT FOR SOFTWARE VALIDATION
3.1. Definitions and Terminology
3.1.1 Requirements and Specifications
3.1.2 Verification and Validation
3.1.3 IQ/OQ/PQ
3.2. Software Development as Part of System Design
3.3. Software is Different from Hardware
3.4. Benefits of Software Validation
3.5 Design Review
SECTION 4. PRINCIPLES OF SOFTWARE VALIDATION
4.1. Requirements
4.2. Defect Prevention
4.3. Time and Effort
4.4. Software Life Cycle
4.5. Plans
4.6. Procedures
4.7. Software Validation After a Change
4.8. Validation Coverage
4.9. Independence of Review
4.10. Flexibility and Responsibility
SECTION 5. ACTIVITIES AND TASKS
Page 3 of 47General Principles of Software Validation; Final Guidance for Indust...
2/16/2002http://www.fda.gov/cdrh/comp/guidance/938.html
5.1. Software Life Cycle Activities
5.2. Typical Tasks Supporting Validation
5.2.1. Quality Planning
5.2.2. Requirements
5.2.3. Design
5.2.4. Construction or Coding
5.2.5. Testing by the Software Developer
5.2.6. User Site Testing
5.2.7. Maintenance and Software Changes
SECTION 6. VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE
6.1. How Much Validation Evidence Is Needed?
6.2. Defined User Requirements
6.3. Validation of Off-the-Shelf Software and Automated Equipment
APPENDIX A - REFERENCES
Food and Drug Administration References
Other Government References
International and National Consensus Standards
Production Process Software References
General Software Quality References
APPENDIX B - DEVELOPMENT TEAM
General Principles of Software Validation
This document is intended to provide guidance. It represents the Agency
’
s
current thinking on this topic. It does not create or confer any rights for or
Page 4 of 47General Principles of Software Validation; Final Guidance for Indust...
2/16/2002http://www.fda.gov/cdrh/comp/guidance/938.html
SECTION 1. PURPOSE
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 used 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.
SECTION 2. SCOPE
This guidance describes how certain provisions of the medical device Quality System
regulation apply to software and the agency
’
s 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 list all
of the activities and tasks that must, in all instances, be used to comply with the
law.
The scope of this guidance is somewhat broader than the scope of validation in the
strictest definition 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.
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 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 throughout the entire software
life cycle.
Where the software is developed by someone other than the device manufacturer
(e.g., off-the-shelf software) the software developer may not be directly
responsible for compliance with FDA regulations. In that case, the party with
regulatory responsibility (i.e., the device manufacturer) needs to assess the
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 approach satisfies
the requirements of the applicable statutes and regulations.
Page 5 of 47General Principles of Software Validation; Final Guidance for Indust...
2/16/2002http://www.fda.gov/cdrh/comp/guidance/938.html
剩余46页未读,继续阅读
yanyu111112
- 粉丝: 0
- 资源: 4万+
下载权益
C知道特权
VIP文章
课程特权
开通VIP
上传资源 快速赚钱
- 我的内容管理 展开
- 我的资源 快来上传第一个资源
- 我的收益 登录查看自己的收益
- 我的积分 登录查看自己的积分
- 我的C币 登录后查看C币余额
- 我的收藏
- 我的下载
- 下载帮助
安全验证
文档复制为VIP权益,开通VIP直接复制
信息提交成功
评论0