ABSTRACT

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse

chapter 1|24 pages

Historical Perspective

chapter 2|86 pages

FDA/GLP Regulations

chapter 3|20 pages

Regulation of Computer Systems

chapter 7|30 pages

Computer Systems Validation

chapter 8|18 pages

GLP Documentation