How to Review and Redesign Sop Systems PDF Download
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Author: Michael Cutter
Publisher: Interpharm Press
ISBN: 9780935184983
Category : Medical
Languages : en
Pages : 37
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Book Description
Author: Michael Cutter
Publisher: Interpharm Press
ISBN: 9780935184983
Category : Medical
Languages : en
Pages : 37
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Book Description
Author: Michael Cutter
Publisher: Interpharm Press
ISBN: 9780935184990
Category : Medical
Languages : en
Pages : 150
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Book Description
Author: United States. Army Materiel Command. Historical Office
Publisher:
ISBN:
Category :
Languages : en
Pages : 444
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Book Description
Author: United States. Defense Logistics Studies Information Exchange
Publisher:
ISBN:
Category : Military research
Languages : en
Pages : 504
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Book Description
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Transportation and Treasury, and Independent Agencies Appropriations
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1998
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Book Description
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Transportation and Treasury, and Independent Agencies Appropriations
Publisher:
ISBN:
Category : Political Science
Languages : en
Pages : 1904
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Book Description
Distributed to some depository libraries in microfiche.
Author: United States
Publisher:
ISBN:
Category : Budget
Languages : en
Pages : 1492
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Book Description
Author: Robert McDowall
Publisher: Royal Society of Chemistry
ISBN: 1847552293
Category : Science
Languages : en
Pages : 289
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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.
Author: United States. Department of Health and Human Services
Publisher:
ISBN:
Category :
Languages : en
Pages : 220
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Book Description
Author:
Publisher:
ISBN:
Category : American literature
Languages : en
Pages : 3310
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