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本文按标准与记录的观点分类,初步剖析了药品生产管理规范所要求的软件系统,旨在引起讨论,制订符合国际要求的中国药品生产质量管理规范的软件体系。
This dissertation, based on the standards and records, first analyzes the software system required by the code of drug production management, aiming to arouse discussion and formulate the software system of Chinese pharmaceutical production quality management in line with international requirements.