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Master Thesis

Projet de mise en place et optimisation d’un dossier de lot électronique dans l’industrie pharmaceutique et son lien avec l’intégrité des données

Abstract : The notion of data integrity is becoming increasingly important in the pharmaceutical industries. Incidents identified during inspections significantly increase and disrupt trust of health authorities and the general public. Publications, guides are disseminated through structures to clarify this emerging subject, to highlight its importance and to clarify regulatory requirements. Digitalization and technological progress are part of this industry and must be adapted to these new requirements. Recent modern tools such as the electronic batch file must comply with data integrity from the design phases to restore a high-performance quality system. Managing such a project is a complex task involving many stakeholders. Flexibility is required in the management of computerized systems to cope with these constant developments. Adjustments will be requested even once the system is active and validated through optimizations to perfect its use in a continuous improvement process.
Document type :
Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03043021
Contributor : Frédérique Gambade Connect in order to contact the contributor
Submitted on : Monday, December 7, 2020 - 9:53:24 AM
Last modification on : Friday, January 22, 2021 - 3:11:37 AM
Long-term archiving on: : Monday, March 8, 2021 - 6:23:19 PM

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  • HAL Id : dumas-03043021, version 1

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Alexandre Charrier. Projet de mise en place et optimisation d’un dossier de lot électronique dans l’industrie pharmaceutique et son lien avec l’intégrité des données. Sciences du Vivant [q-bio]. 2020. ⟨dumas-03043021⟩

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