Validation of Chromatography Data Systems

Released on by Robert McDowall
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  • Validation of Chromatography Data Systems Book Detail

  • Author : Robert McDowall
  • Release Date : 2007-10-31
  • Publisher : Royal Society of Chemistry
  • Genre : Science
  • Pages : 289
  • ISBN 13 : 1847552293
  • File Size : 47,47 MB
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Validation of Chromatography Data Systems by Robert McDowall PDF Summary

Book Description: 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.

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Validation of Chromatography Data Systems

Validation of Chromatography Data Systems

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Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associa

Validation of Chromatography Data Systems

Validation of Chromatography Data Systems

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Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and reg

Validation of Chromatography Data Systems

Validation of Chromatography Data Systems

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Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associa

Validating Chromatographic Methods

Validating Chromatographic Methods

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All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufactur