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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| Main Author: | |
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| Corporate Author: | |
| Format: | eBook |
| Language: | English |
| Published: |
Cambridge :
Royal Society of Chemistry,
©2005.
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| Series: | RSC chromatography monographs.
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| Subjects: | |
| ISBN: | 9781615833726 1615833722 9781847552297 1847552293 085404969X 9780854049691 |
| Physical Description: | 1 online resource (xxix, 259 pages) : illustrations |
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Table of contents
| LEADER | 05398cam a2200469 a 4500 | ||
|---|---|---|---|
| 001 | kn-ocn647959285 | ||
| 003 | OCoLC | ||
| 005 | 20240717213016.0 | ||
| 006 | m o d | ||
| 007 | cr cn||||||||| | ||
| 008 | 100715s2005 enka ob 001 0 eng d | ||
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| 020 | |a 9781615833726 |q (electronic bk.) | ||
| 020 | |a 1615833722 |q (electronic bk.) | ||
| 020 | |z 9781847552297 | ||
| 020 | |z 1847552293 | ||
| 020 | |z 085404969X | ||
| 020 | |a 9780854049691 |q (electronic bk.) | ||
| 020 | |a 085404969X |q (electronic bk.) | ||
| 035 | |a (OCoLC)647959285 |z (OCoLC)229402387 |z (OCoLC)232637903 |z (OCoLC)506349804 |z (OCoLC)605918053 |z (OCoLC)961606027 |z (OCoLC)962709446 |z (OCoLC)966641118 |z (OCoLC)972044729 |z (OCoLC)988413553 |z (OCoLC)1027381864 |z (OCoLC)1037731031 |z (OCoLC)1038667414 |z (OCoLC)1045517887 |z (OCoLC)1055403951 |z (OCoLC)1062184442 |z (OCoLC)1065911218 |z (OCoLC)1077996617 |z (OCoLC)1086526380 |z (OCoLC)1153465951 |z (OCoLC)1157022345 |z (OCoLC)1228607065 |z (OCoLC)1256376032 |z (OCoLC)1391811226 |z (OCoLC)1410734254 | ||
| 100 | 1 | |a McDowall, R. D. | |
| 245 | 1 | 0 | |a Validation of chromatography data systems : |b meeting business and regulatory requirements / |c R.D. McDowall. |
| 260 | |a Cambridge : |b Royal Society of Chemistry, |c ©2005. | ||
| 300 | |a 1 online resource (xxix, 259 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 490 | 1 | |a RSC chromatography monographs | |
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a Introduction to chromatography data systems -- Regulatory requirements for CDS validation -- Concepts of computer validation -- CDS validation : managing system risk -- Process redesign to exploit the tangible benefits of electronic signatures with a CDS -- Writing the user requirements specification -- Controlling the work : the validation plan -- System selection -- Auditing the CDS vendor -- Contract, purchase order and planning the installation -- Risk assessment and requirements traceability -- Installation qualification and operational qualification -- Performance qualification (PQ) or end-user testing -- User training and system documentation -- IT support of the system -- System description -- Validation summary report -- Defining electronic records for a CDS -- Maintaining the validation status during operational life -- Periodic review of the CDS -- Records retention -- CDS data migration -- CDS system retirement -- Retrospective validation. | |
| 506 | |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty | ||
| 520 | |a 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. | ||
| 590 | |a Knovel |b Knovel (All titles) | ||
| 650 | 0 | |a Chromatographic analysis. | |
| 650 | 0 | |a Computer software |x Validation. | |
| 650 | 0 | |a Computer programs |x Validation. | |
| 655 | 7 | |a elektronické knihy |7 fd186907 |2 czenas | |
| 655 | 9 | |a electronic books |2 eczenas | |
| 710 | 2 | |a Royal Society of Chemistry (Great Britain) | |
| 776 | 0 | 8 | |i Print version: |a McDowall, R.D. |t Validation of chromatography data systems. |d Cambridge : Royal Society of Chemistry, ©2005 |z 085404969X |w (DLC) 2006284110 |w (OCoLC)57691594 |
| 830 | 0 | |a RSC chromatography monographs. | |
| 856 | 4 | 0 | |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpVCDSMBR1/validation-of-chromatography?kpromoter=marc |y Full text |
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