This complete guide and reference explains how to improve product quality while
achieving compliance with the world's regulatory standards. It shows how to
develop and implement a validation strategy for routine, nonroutine, and
standard analytical methods encompassing the entire equipment hardware and
software qualification process. It includes examples and templates to help
readers through the validation process. In addition to guidelines on the
qualification of standards, certified and in-house reference materials, and
employee qualification, it covers internal and third-party lab audits and
inspections.