Record Display for the EPA National Library Catalog
RECORD NUMBER: 1 OF 1Main Title | Validation of computerized analytical systems | |||||||||||
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Author | Huber, Ludwig | |||||||||||
Publisher | Interpharm Press, | |||||||||||
Year Published | 1995 | |||||||||||
OCLC Number | 33159592 | |||||||||||
ISBN | 0935184759 | |||||||||||
Subjects | Expert systems (Computer science)--Validation ; Computer programs--Validation ; Laboratories--Quality control ; Validation Systems | |||||||||||
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Collation | xii, 252 p. : ill. ; 27 cm. | |||||||||||
Notes | Includes bibliographical references (p. 233-244) and indexes. |
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Contents Notes | 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. |