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Master Thesis

Amélioration continue en industrie pharmaceutique : le processus de gestion des actions correctives et préventives soutenu par les systèmes informatisés

Abstract : Considering the current changes in the regulations and standards (ICH Q10, ISO 9001: 2015, etc…), it becomes necessary, for the pharmaceutical industry, to enter into a continuous improvement process. The latter involves, in particular, a good management of the corrective and preventive action system. The authorities requesting only a final performance result, the means implemented to conduct the different system phases by the companies are numerous. Thus, this thesis aims to present the means to manage this complex process.The latter is composed of several stages, in which basic or complex quality tools are involved: problem detection, root cause investigation and action plan. If one of these stages is not conducted in a completed way, the rest of the process may lead to a lack of actions or to the implementation of ineffective corrective and preventive actions. Which is money and time-consuming for the company. The optimal conditions for the process to be efficient are met if a qualified staff is involved and relevant documentation is associated. A good communication and the indicator use are essential. On the other hand, the laboratories can rely on IT solutions such as EtQ and Ennov facilitating the CAPA process control. These softwares are very good workflow management tools and take up the majority of the elements composing the management system of corrective and preventive actions. However, the risk evaluation and investigation completion, and the action determination are still non-computerized stages.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01611338
Contributor : Jean-Hugues Morneau <>
Submitted on : Thursday, October 5, 2017 - 4:57:01 PM
Last modification on : Wednesday, July 15, 2020 - 8:56:03 AM
Long-term archiving on: : Monday, January 8, 2018 - 12:57:02 PM

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  • HAL Id : dumas-01611338, version 1

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Charlotte Thenoz. Amélioration continue en industrie pharmaceutique : le processus de gestion des actions correctives et préventives soutenu par les systèmes informatisés. Sciences pharmaceutiques. 2017. ⟨dumas-01611338⟩

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