The article puts forword some views on strengthening the management of soft ware in pharmaceutical enterprises in following respects : Quality assurance unit, quality control in production process, management for substandard products, records and labels. 本文从强化质量管理部门、加强中间控制,不合格品管理,原始记录和标签管理等五个方面,对加强药厂的软件管理,提出几点看法。
Drug regulation is the use of government regulation in pharmaceutical field, the core is to ensure the safety of drugs, but we should take other basic goals such as availability, quality assurance, reasonable use. 药品管制是政府管制在药品领域的运用,其核心是确保药品的安全性,但要兼顾可获得性、质量保证、合理使用等基本目标。