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
c2005
|
| Schriftenreihe: | RSC chromatography monographs
|
| Schlagworte: | |
| Online-Zugang: | FAW01 FAW02 Volltext |
| Beschreibung: | Includes bibliographical references and index 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 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 (xxix, 259 p.) |
| ISBN: | 1615833722 1847552293 9781615833726 9781847552297 |
Internformat
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| 500 | |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 | ||
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Datensatz im Suchindex
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|---|---|
| any_adam_object | |
| author | McDowall, R. D. |
| author_facet | McDowall, R. D. |
| author_role | aut |
| author_sort | McDowall, R. D. |
| author_variant | r d m rd rdm |
| building | Verbundindex |
| bvnumber | BV043077365 |
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| dewey-full | 543.8 |
| dewey-hundreds | 500 - Natural sciences and mathematics |
| dewey-ones | 543 - Analytical chemistry |
| dewey-raw | 543.8 |
| dewey-search | 543.8 |
| dewey-sort | 3543.8 |
| dewey-tens | 540 - Chemistry and allied sciences |
| discipline | Chemie / Pharmazie |
| format | Electronic eBook |
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| id | DE-604.BV043077365 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:16:44Z |
| institution | BVB |
| isbn | 1615833722 1847552293 9781615833726 9781847552297 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-028501557 |
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| physical | 1 Online-Ressource (xxix, 259 p.) |
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| publishDate | 2005 |
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| spelling | McDowall, R. D. Verfasser aut Validation of chromatography data systems meeting business and regulatory requirements R.D. McDowall Cambridge Royal Society of Chemistry c2005 1 Online-Ressource (xxix, 259 p.) txt rdacontent c rdamedia cr rdacarrier RSC chromatography monographs Includes bibliographical references and index 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 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 Chromatographie / Logiciels ram Logiciels / Validation ram Chromatographie Logiciels / Validation SCIENCE / Chemistry / Analytic bisacsh Chromatographic analysis fast Computer software / Validation fast Chemie Chromatographic analysis Computer software Validation 1\p (DE-588)4006432-3 Bibliografie gnd-content Royal Society of Chemistry (Great Britain) Sonstige oth http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=496351 Aggregator Volltext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | McDowall, R. D. Validation of chromatography data systems meeting business and regulatory requirements Chromatographie / Logiciels ram Logiciels / Validation ram Chromatographie Logiciels / Validation SCIENCE / Chemistry / Analytic bisacsh Chromatographic analysis fast Computer software / Validation fast Chemie Chromatographic analysis Computer software Validation |
| 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 R.D. McDowall |
| title_fullStr | Validation of chromatography data systems meeting business and regulatory requirements R.D. McDowall |
| title_full_unstemmed | Validation of chromatography data systems meeting business and regulatory requirements R.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 | Chromatographie / Logiciels ram Logiciels / Validation ram Chromatographie Logiciels / Validation SCIENCE / Chemistry / Analytic bisacsh Chromatographic analysis fast Computer software / Validation fast Chemie Chromatographic analysis Computer software Validation |
| topic_facet | Chromatographie / Logiciels Logiciels / Validation Chromatographie SCIENCE / Chemistry / Analytic Chromatographic analysis Computer software / Validation Chemie Computer software Validation Bibliografie |
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