OneSource® UOQ 计划提供了仪器确认规程,以实现最大的生产力和持续的监管合规。该规程包括在适用的情况下,满足药典(USP、EP和JP)的设计和方法,并且该内容是简化了所有主要型号的实验室仪器(无论制造商是谁)的文件。OneSource 合规服务确保最大程度符合国际法规和指南。UOQ 实现了一种无缝的、跨平台的可同步并自动化地文档处理方式,让您从计算机或数据库中立即获得原始数据,以提高科学生产力。
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您还能从以下方面受益:
UOQ 旨在通过使用符合美国联邦法典第21章第11部分的智能化PDF来提高OQ技术的合规性。UOQ 是一个遵守 ALCOA 的可配置方案,增加了安全性并简化了多个仪器供应商的确认过程。
通过我们的 UOQ 服务,您可以提高科学生产力,增加仪器可用性,减少因仪器停机而产生的总体成本,并使组织的总体效率最大化。这是因为 UOQ 服务简化了所有实验室仪器的确认过程,将其整合为单一的综合解决方案。此外,为了便于文件追踪,它能使您对所有型号的实验室仪器(无论制造商是谁)的文件进行统一管理。该服务:
Universal electronic documentation takes care of instrument compliance testing, allowing researchers to get back to the bench. Regulatory demands on research are increasing, which decreases scientists’ productivity. From scheduling and running multiple tests on instruments from different vendors to ...
Regulatory compliance is essential for laboratories to ensure adherence to standards set by regulatory agencies. However, achieving lab compliance is complex and involves multiple facets such as software validation, data integrity, equipment qualification, calibration, maintenance, personnel trainin ...
The time and resources needed to meet global requirements for regulatory inspections and remaining compliant are at odds with laboratories’ needs to increase productivity and reduce operating costs. Now you can harmonize documentation across all models of lab instruments, regardless of the manufactu ...
Revision to General Chapter USP 857, which emphasized on performance specifications for UV-Vis Spectrometers (e.g. Lambda 365), on December 1st 2019 USP officially announced the amended chapter with new regulations on testing parameters. There are some major modifications made related to calibration ...