It is an important tool for WHO and drug regulators in their efforts to harmonize regulation and improve the safety, efficacy and quality of medicines globally.
它是世卫组织和药品监管人员用以努力在全球协调监管并改进药物安全性、效力和质量的一个重要工具。
An effective quality System Can harmonize the relationship between Processes, and define the interface relationship of them.
一个有效的质量体系能够协调好各种过程的关系,并能明确这些过程间的相互接口关系。
The process defines order of using the methods, document files required to deliver, required management to guarantee quality and harmonize changes, and complete milestones of phases.
过程定义了方法使用的顺序、要求交付的文档资料、为保证质量和协调变化所需要的管理、及软件开发各个阶段完成的里程碑。
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