Validation of chromatography data systems : meeting business and regulatory requirements

Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatogra...

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Bibliographic Details
Main Author: McDowall, R. D.
Corporate Author: Royal Society of Chemistry (Great Britain)
Format: eBook
Language: English
Published: Cambridge : Royal Society of Chemistry, ©2005.
Series: RSC chromatography monographs.
Subjects:
ISBN: 9781615833726
1615833722
9781847552297
1847552293
085404969X
9780854049691
Physical Description: 1 online resource (xxix, 259 pages) : illustrations

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Summary: Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.
Bibliography: Includes bibliographical references and index.
ISBN: 9781615833726
1615833722
9781847552297
1847552293
085404969X
9780854049691
Access: Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty