Laboratory Auditing for Quality and Regulatory Compliance - 9780367392468

CRC Press

Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance. > Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance. > Introduction. Quality and Auditing. Quality Control and Quality Assurance in a Laboratory. The Regulated Industries. Goals of a Laboratory Quality Audit. Audit Tools : Observation, Working Knowledge and Audit Documents. Non-Technical Parameters for Evaluation. Quality Programs, Organizational Structure and Documentation. Personnel. Facility and Environment. Technical Parameters for Evaluation. Sample Control. Instrumentation. Automation of Analytical Process. Acquisition and Processing of Data. Uncertainty o.