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电子质量管理系统与质量风险管理的战略整合:促进药品合规性和运营卓越

Shikha Baghel Chauhan1, Indu Singh1, Radhakrishan Gaur1

  • 1Amity Institute of Pharmacy, Amity University, Noida, UP, 201313, India.

Current pharmaceutical design
|March 15, 2026
PubMed
概括

将电子质量管理系统 (EQMS) 与质量风险管理 (QRM) 框架相结合,可以提高药品质量. 这种协同作用促进了主动的合规性,减少了变化,并促进了对运营卓越的持续改进.

关键词:
在 ICH Q9.9 中.药品合规性 药品合规性 药品合规性基于云的质量系统数据完整性的数据完整性.监管事务 监管事务

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