Výsledky vyhledávání - "Siri H. Segalstad"

Laboratory Information Management System (LIMS)

Autor: Siri H Segalstad

Publikováno v: Encyclopedia of Pharmaceutical Science and Technology, Fourth Edition ISBN: 9781841848204

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::7c3f8439ada0c240dd722c0e6a36d66c
https://doi.org/10.1081/e-ept4-120016557

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Vendor audits for computer systems: ISO 9000-3 approach

Autor: Siri H. Segalstad

Publikováno v: Laboratory Automation & Information Management. 32:23-31

Computer systems used in quality environments need to be under total quality management during use and should be developed in a quality environment. The user can investigate the development environment by auditing the vendor, regardless of whether th

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::84b94bcc9854e28dcfaf761bfe45aebd
https://doi.org/10.1016/1381-141x(96)00003-2

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Quality assurance of computer systems what is needed to comply with ISO 9000, GMP, GLP, and GCP?

Autor: Siri H. Segalstad

Publikováno v: Laboratory Automation & Information Management. 31:11-24

This paper will interpret the application of the different quality standards like Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and ISO 9000-3 guidelines to computer systems. The ISO 9000-3 contains r

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::24c22705e5cfc734e857855736df6151
https://doi.org/10.1016/1381-141x(95)80011-q

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A practical guide to validating LIMS

Autor: Siri H. Segalstad, Magne J. Synnevåg

Publikováno v: Chemometrics and Intelligent Laboratory Systems. 26:1-12

This Tutorial gives a practical approach to validating a LIMS computer system, with details from our own validation. Contents of validation protocol and validation plan, responsibilities, and documentation needed and created during the validation are

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::7f72e55dc63fd142058ebc55dcdafaae
https://doi.org/10.1016/0169-7439(94)90013-2

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The Legal Implications of an IT System

Autor: Siri H. Segalstad