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Approach to the Integration of Management Systems in a Pharmaceutical Organization

机译:制药组织管理系统集成的方法

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This paper discusses how a system approach to management can be used for the development and implementation of an integrated management system (IMS) in a company producing medicinal products. It is argued in the paper that approaches to the solutions of how to integrate management systems all require two elements: a conceptual model and a supporting methodology. Although a large number of models has been developed that could provide the basis for integration, development of methodologies to achieve fully integrated systems is still stagnating. This paper presents the IMS model that can be used to integrate the requirements of existing and upcoming standards in the pharmaceutical industry, followed by a discussion on the issue of the IMS methodology.
机译:本文讨论了在生产药品的公司中如何将系统管理方法用于开发和实施集成管理系统(IMS)。本文认为,解决方案如何集成管理系统的方法都需要两个要素:概念模型和支持方法。尽管已经开发了许多模型,可以为集成提供基础,但是实现完全集成的系统的方法开发仍然停滞不前。本文介绍了IMS模型,该模型可用于整合制药行业现有标准和即将颁布的标准的要求,然后讨论IMS方法论问题。

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