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Specification developer - a software for writing specifications for pharmaceutical equipment

机译:规范开发人员 - 用于制作制药设备规格的软件

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Specification of a product is the description of the product upon which its development is based. However at present, every product is specified differently and to different levels of abstraction. In industry, acquisition of major systems follows a detailed process that usually commences with initial identification of the need for the system. This continues through the various stages of system design, system build, system validation, commissioning, testing and finally release to the end user. For complex systems incorporating unique designs, new technologies and extensive engineering integration, the acquisition process incorporates numerous activities and may take years to complete. Systems possessing all of these characteristics must be specified in such a way as to totally minimise areas of ambiguity which could affect final design effectiveness and in some cases render the design as useless. As a result of this the specification documents run into several volumes. For acquisition of lesser systems, in many cases the conceptual design and specifications for procurement are developed to very tight schedules. This originates different types of problems as time factors restrict concise design detail, and the opportunity to explore diverse alternatives. Therefore structuring of the 'Specification' is an important area of research. Mature projects using computer-based software have been developed to provide a generic framework, for 'writing specifications for pharmaceutical equipment. 'Specification Developer' as the software is known, has been developed in three stages to reach its present β status. These are: (i) survey of the related work and identification of the constituent elements, (ii) development of the methodology and the software to work in a PC environment, and (iii) testing the methodology with an existing project case study. Several live industrial case studies have been carried out utilising 'Specification Developer' software to construct specifications for a range of hightech pharmaceutical equipment. This paper describes the software structure.
机译:产品的规格是其开发基础的产品的描述。然而,目前,每个产品都被不同地指定以及不同水平的抽象。在工业中,收购主要系统遵循一个详细的过程,通常开始初步识别系统的需要。这继续通过系统设计,系统构建,系统验证,调试,测试以及最终释放到最终用户的各个阶段。对于包含独特设计,新技术和广泛的工程整合的复杂系统,收购流程纳入了众多活动,可能需要数年才能完成。必须以完全最小化可能影响最终设计效果的歧义区域,并且在某些情况下将设计变为无用的方法,这些系统必须以完全最小化。由于此,规范文档陷入了几卷。对于收购较小系统,在许多情况下,采购的概念设计和规范都被开发为非常紧张的时间表。这起源于不同类型的问题,因为时间因素限制了简洁的设计细节,以及探索各种替代方案的机会。因此,“规范”的结构是一个重要的研究领域。已经开发了使用基于计算机的软件的成熟项目来提供通用框架,用于“制药设备的书写规范”。 “规范开发人员”作为软件已知,已在三个阶段开发,以达到其目前的β状态。这些是:(i)对组成部分的相关工作和鉴定的调查,(ii)在PC环境中工作的方法和软件的开发,(iii)与现有项目案例研究测试方法。利用“规范开发人员”软件进行了几项现场工业案例研究,以构建一系列高科医药设备的规格。本文介绍了软件结构。

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