The final Device Center Inspection Compliance Policy Guide (provided at the link above and in the Library on this site) Part VI, Page 11, lists the following as points of contact related to software: “i. Questions regarding compliance of product software, stand alone software, process equipment software or the Year: 2000 Problem: Stewart Crumpler Office...Read More
Last fall John Taylor, Director, FDA Office of Enforcement took over as leader of the agency’s Part 11 Compliance Committee. As of January 2001: 1. The draft guidances on Validation and Glossary of Terms are now in formal review at the agency. This does not mean they are close to final. 2. FDA has suspended...Read More
The Device Quality System Regulation (GMP) explicitly requires signatures in the following places: The sections of the regulation which specifically require signatures are: · Sec. 820.30 Design controls.c & d · Sec. 820.40 Document controls a & b · Sec. 820.75 Process validation a · Sec. 820.80 Receiving, in-process, and finished device acceptance d&e. ·...Read More
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.