General principles of software validation : final guidance for industry and FDA staff
| Other author | Center for Biologics Evaluation and Research (U.S.) |
| Format | Electronic |
| Publication Info | Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2002] |
| Description | iv, 43 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS113110 |
| Subjects |
| General note | Title from PDF title page (viewed on May 27, 2009). |
| General note | "Supersedes the draft document "General principles of software validation["], version 1.1, dated June 9,1997". |
| General note | "Document issued on: January 11, 2002". |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Bibliography note | Includes bibliographical references (p. 35-42). |
| Technical details | Mode of access: Internet at the FDA CBER web site. Address as of 5/27/09: http://www.fda.gov/cdrh/comp/guidance/938.pdf ; current access is available via PURL. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:SO 2 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |