Managing laboratory automation in a changing pharmaceutical industry.

M L Rutherford
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Abstract

The health care reform movement in the USA and increased requirements by regulatory agencies continue to have a major impact on the pharmaceutical industry and the laboratory. Laboratory management is expected to improve effciency by providing more analytical results at a lower cost, increasing customer service, reducing cycle time, while ensuring accurate results and more effective use of their staff. To achieve these expectations, many laboratories are using robotics and automated work stations. Establishing automated systems presents many challenges for laboratory management, including project and hardware selection, budget justification, implementation, validation, training, and support. To address these management challenges, the rationale for project selection and implementation, the obstacles encountered, project outcome, and learning points for several automated systems recently implemented in the Quality Control Laboratories at Eli Lilly are presented.

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在不断变化的制药行业中管理实验室自动化。
美国的卫生保健改革运动和监管机构要求的增加继续对制药工业和实验室产生重大影响。实验室管理有望提高效率,以更低的成本提供更多的分析结果,增加客户服务,减少周期时间,同时确保准确的结果和更有效地利用他们的员工。为了实现这些期望,许多实验室正在使用机器人和自动化工作站。建立自动化系统对实验室管理提出了许多挑战,包括项目和硬件选择、预算论证、实施、验证、培训和支持。为了解决这些管理挑战,介绍了项目选择和实施的基本原理,遇到的障碍,项目结果,以及最近在礼来公司质量控制实验室实施的几个自动化系统的学习点。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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