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Computer systems validation for the pharmaceutical and medical device industries
서명 / 저자 Computer systems validation for the pharmaceutical and medical device industries / Richard Chamberlain.
판사항 2nd ed.
발행사항 Libertyville, Il. : ALAREN Press, c1994.

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5020262

소장위치/청구기호

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HD9665.5 .C42 1994

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청구기호 HD9665.5 .C42 1994
형태사항 xiv, 356 p. : ill. ; 25 cm + 2 computer diskettes (5 1/2 in. and 3.25 in.)
언어 English
서지주기 Includes bibliographical references and index.
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.
주제 Medical instruments and apparatus --Design.
Medical instruments and apparatus --Quality control.
Pharmaceutical industry --Data processing.
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