Transcription of General Principles of Software Validation; Final …
1 Copyright eCompliance 2015 1 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 , dated June 9, 1997. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Copyright eCompliance 2015 2 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)
2 , Rockville, MD, 20852 the Center for Devices and Radiological Health (CDRH) (301) 594-4659 / email John F. Murray the Center for Biologics Evaluation and Research (CBER) (301) 827-6220 / email Jerome Davis CDRH CDRH Facts-On-Demand FA X 800-899-0381 / 301-827-0111 CDRH Facts-On-Demand system CBER CBER, Office of Communication, Training, and Manufacturers' Assistance (HFM-40)
3 , 1401 Rockville Pike, Rockville, Maryland 20852-1448 1- 800-835-5709 / 301-827-1800 Copyright eCompliance 2015 3 1.. 5 2.. 5 .. 5 .. 6 .. 6 .. 6 .. 7 3.. 9 .. 9 .. 9 .. 10 IQ/OQ/PQ .. 11 .. 11 .. 11 .. 13 .. 13 4.. 15 .. 15 .. 15 .. 15 .. 15 .. 15.
4 16 .. 16 .. 16 .. 16 .. 17 5.. 18 .. 18 .. 18 .. 19 .. 20 .. 21 .. 23 .. 24 .. 30 .. 31 Copyright eCompliance 2015 4 6.. 33 .. 34 .. 34 .. 35 Copyright eCompliance 2015 5 FDA FDA 1.
5 Food and Drug Administration(FDA) Version General Principles of Software validation , Version , dated June 9, 1997. 2. FDA
6 FDA Copyright eCompliance 2015 6 PLC FDA the Federal Food, Drug, and Cosmetic Act (the Act) Section 201 (h)
7 FDA Software and regulatory policy FDA FDA FDA the CDRH Ombudsman CDRH Ombudsman 3140 FDA 1992 1998 242 192 79 1996 10 the Federal Register Copyright eCompliance 2015 7 1997 6
8 1 Title 21 Code of Federal Regulations (CFR) Part 820, 61 Federal Register (FR) 52602, 1997 6 1 21 CFR 21 CFR (g) 21 CFR 21 CFR (i).
9 21 CFR (a). /
10 Section FDA Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices. Copyright eCompliance 2015 8 FDA the Office of Device Evaluation (ODE)
