This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.

Historical Perspective. FDA/GLP Regulations. Applying 21 CFR Part 11 to the Laboratory Environment. The Good Automated Laboratory Practices. Implementing GLPs in a Non-GLP Analytical Laboratory. Controlling the GLP Inspection Process. Computer Systems Validation. GLP Documentation. The FDA's GLP Inspection Program. The Future of Good Laboratory Practice Regulations