Includes bibliographical references (p. 233-244) and indexes.

Regulations and quality standards -- Definitions: computer systems, computerized systems and software -- Validation processes in the analytical laboratory -- Life cycle approach for validation of software and computer systems -- Validation efforts at the vendor's site -- Responsibilities of vendors and users -- Calibration, verification and validation of equipment -- Selection and qualification of a vendor -- Installation and operation -- Validation of analytical methods -- Maintainance and ongoing performance control -- Testing of chromatographic computer systems -- Data validation, audit trail, security and traceablity -- Diagnostics, error recording and reporting -- Audit/inspection of computerized systems.