Validation of chromatography data systems: Meeting business and regulatory requirements
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Cambridge
Royal Society of Chemistry
2005
[distributor] RSC Distribution Services] |
| Schriftenreihe: | RSC Chromatography monographs
|
| Schlagworte: | |
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| Beschreibung: | This product is not available separately, it is only sold as part of a set. There are 750 products in the set and these are all sold as one entity, 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 |
| Beschreibung: | 1 Online-Ressource (290 p.) |
| ISBN: | 1847552293 9781847552297 |
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Datensatz im Suchindex
| DE-BY-FWS_katkey | 392201 |
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| _version_ | 1806177845292040192 |
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| author | McDowall, Robert D. |
| author_facet | McDowall, Robert D. |
| author_role | aut |
| author_sort | McDowall, Robert D. |
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| building | Verbundindex |
| bvnumber | BV037195027 |
| collection | ZDB-1-RSE |
| ctrlnum | (OCoLC)873735865 (DE-599)GBVNLM003688313 |
| discipline | Chemie / Pharmazie |
| format | Electronic eBook |
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| genre | 1\p (DE-588)4006432-3 Bibliografie gnd-content |
| genre_facet | Bibliografie |
| id | DE-604.BV037195027 |
| illustrated | Not Illustrated |
| indexdate | 2024-08-01T11:43:41Z |
| institution | BVB |
| isbn | 1847552293 9781847552297 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-021109389 |
| oclc_num | 873735865 |
| open_access_boolean | |
| owner | DE-12 DE-384 DE-473 DE-BY-UBG DE-703 DE-29 DE-19 DE-BY-UBM DE-91 DE-BY-TUM DE-739 DE-355 DE-BY-UBR DE-20 DE-Aug4 DE-1046 DE-1047 DE-1102 DE-1050 DE-859 DE-M347 DE-92 DE-898 DE-BY-UBR DE-863 DE-BY-FWS DE-862 DE-BY-FWS DE-128 DE-54 DE-22 DE-BY-UBG DE-150 DE-155 DE-BY-UBR DE-210 DE-2070s DE-634 DE-526 DE-860 DE-70 DE-B768 |
| owner_facet | DE-12 DE-384 DE-473 DE-BY-UBG DE-703 DE-29 DE-19 DE-BY-UBM DE-91 DE-BY-TUM DE-739 DE-355 DE-BY-UBR DE-20 DE-Aug4 DE-1046 DE-1047 DE-1102 DE-1050 DE-859 DE-M347 DE-92 DE-898 DE-BY-UBR DE-863 DE-BY-FWS DE-862 DE-BY-FWS DE-128 DE-54 DE-22 DE-BY-UBG DE-150 DE-155 DE-BY-UBR DE-210 DE-2070s DE-634 DE-526 DE-860 DE-70 DE-B768 |
| physical | 1 Online-Ressource (290 p.) |
| psigel | ZDB-1-RSE |
| publishDate | 2005 |
| publishDateSearch | 2005 |
| publishDateSort | 2005 |
| publisher | Royal Society of Chemistry [distributor] RSC Distribution Services] |
| record_format | marc |
| series2 | RSC Chromatography monographs |
| spellingShingle | McDowall, Robert D. Validation of chromatography data systems Meeting business and regulatory requirements |
| subject_GND | (DE-588)4006432-3 |
| title | Validation of chromatography data systems Meeting business and regulatory requirements |
| title_auth | Validation of chromatography data systems Meeting business and regulatory requirements |
| title_exact_search | Validation of chromatography data systems Meeting business and regulatory requirements |
| title_full | Validation of chromatography data systems Meeting business and regulatory requirements by Robert D. McDowall |
| title_fullStr | Validation of chromatography data systems Meeting business and regulatory requirements by Robert D. McDowall |
| title_full_unstemmed | Validation of chromatography data systems Meeting business and regulatory requirements by Robert D. McDowall |
| title_short | Validation of chromatography data systems |
| title_sort | validation of chromatography data systems meeting business and regulatory requirements |
| title_sub | Meeting business and regulatory requirements |
| topic_facet | Bibliografie |
| url | http://www.rsc.org/publishing/ebooks/2005/9780854049691.asp |
| work_keys_str_mv | AT mcdowallrobertd validationofchromatographydatasystemsmeetingbusinessandregulatoryrequirements |