Data integrity in regulated bioanalysis: a summary from the European Bioanalysis Forum Workshop in collaboration with the MHRA
| Autor: | Cecilia Arfvidsson, Magnus Knutsson, Susanne Globig, David Van Bedaf, Marco Michi, Stuart McDougall, Mark Lewis, Philip Timmerman, Nathalie Mokrzycki, Mira Doig |
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| Rok vydání: | 2019 |
| Předmět: |
Engineering
Bioanalysis business.industry 010401 analytical chemistry Clinical Biochemistry General Medicine 030226 pharmacology & pharmacy 01 natural sciences 0104 chemical sciences Analytical Chemistry 03 medical and health sciences Medical Laboratory Technology Engineering management 0302 clinical medicine Software Audit trail Data integrity Regulatory agency General Pharmacology Toxicology and Pharmaceutics business System software |
| Zdroj: | Bioanalysis. 11:1227-1231 |
| ISSN: | 1757-6199 1757-6180 |
| Popis: | In this conference report, we summarize the main findings and messages from a workshop on ‘Data Integrity’. The workshop was held at the 11th European Bioanalysis Forum Open (EBF) Symposium in Barcelona (21–23 November 2018), in collaboration with the Medicines and Health products Regulatory Agency to provide insight and understanding of regulatory data integrity expectations. The workshop highlighted the importance of engaging with software developers to address the gap between industry’s data integrity needs and current system software capabilities. Delegates were also made aware of the importance of implementing additional procedural controls to mitigate the risk associated with using systems that do not fully meet data integrity requirements. |
| Databáze: | OpenAIRE |
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