Introducing automation to a regulated laboratory – an experience report
2020; Future Science Ltd; Volume: 12; Issue: 10 Linguagem: Inglês
10.4155/bio-2020-0118
ISSN1757-6199
Autores Tópico(s)Statistical Methods in Clinical Trials
ResumoBioanalysisVol. 12, No. 10 CommentaryIntroducing automation to a regulated laboratory – an experience reportMichael GröschlMichael Gröschl*Author for correspondence: E-mail Address: michael.groeschl@celerion.comCelerion Switzerland AG, Allmendstrasse 32, Fehraltorf 8320, SwitzerlandPublished Online:5 Jun 2020https://doi.org/10.4155/bio-2020-0118AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: 21CFRp11computerized system validationlaboratory automationliquid handlingReferences1. US FDA. FDA 21 CFR Part 11, Code of Federal Regulations (1997). https://www.fda.gov/media/75414/downloadGoogle Scholar2. US FDA. EU Guidelines to GMP Annex 11 Computerized Systems (2011). https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdfGoogle Scholar3. EU Directorate for the Quality of Medicines and Healthcare. Guidelines for the Validation of Computerized Systems (2018). https://www.edqm.eu/sites/default/files/guidelines-omcl-computerised_systems-core_document-march2018.pdfGoogle Scholar4. Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance, Informa Healthcare (2nd Edition). Wingate G (Ed.). London, UK (2010).Google Scholar5. International Society for Pharmaceutical Engineering. GAMP Good Practice Guide: Validation of Laboratory Computerized Systems ISPE (2005). https://ispe.org/publications/guidance-documents/gamp-good-practice-guide-gxp-compliant-laboratory-computerized-systemsGoogle ScholarFiguresReferencesRelatedDetailsCited ByThe Impact of Total Automaton on the Clinical Laboratory Workforce: A Case Study1 May 2022 | Journal of Healthcare Leadership, Vol. Volume 14 Vol. 12, No. 10 Follow us on social media for the latest updates Metrics Downloaded 183 times History Received 28 April 2020 Accepted 12 May 2020 Published online 5 June 2020 Published in print May 2020 Information© 2020 Newlands PressKeywords21CFRp11computerized system validationlaboratory automationliquid handlingFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download
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