청구기호 |
HD9665.5 .C42 1994 |
형태사항 |
xiv, 356 p. : ill. ; 25 cm + 2 computer diskettes (5 1/2 in. and 3.25 in.)
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언어 |
English |
서지주기 |
Includes bibliographical references and index.
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내용 |
History -- Validating computer systems -- Corporate strategy -- Validation and systems development -- Validation protocol -- System description -- Testing -- File management -- Standard operating procedures -- Validating purchased systems -- Documentation -- Implementing a systems validation plan -- Raw data -- Audits and inspections -- Operating in a validated environment -- ISO 9000.
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주제 |
Medical instruments and apparatus --Design.
Medical instruments and apparatus --Quality control.
Pharmaceutical industry --Data processing.
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