生命科学

In this interactive PDF you'll find links to on-demand webinars, FAQ documents, and application notes on proven measurement solutions for life science applications.

作为自动化系统，监测系统可以在国际制药工程协会 (ISPE) 的《良好自动化制造规范》(GAMP®) 指南下进行管理，具体包括《制药生产中自动化系统验证的 GAMP 指南》和《GAMP 5：基于风险的合规 GxP 计算机化系统方法》，通过结构化、基于风险的监测应用管理，确保合规性、质量以及患者安全。

Learn step by step how to optimize your sensor placement for temperature, relative humidity, carbon dioxide (CO₂), and differential pressure in storage areas, cleanrooms, incubators, and more. Whether you're monitoring pharmaceuticals, biologics, or medical devices, this training session will help you ensure that your sensor placement withstands regulatory scrutiny.

Learn how to maintain data integrity in GxP-regulated environmental monitoring systems. This webinar reviews current FDA and global regulatory expectations, common data management failures, and real warning letter examples. Gain practical guidance on identifying data integrity risks, avoiding common pitfalls, and applying best practices through expert-led Q&A.

与 FDA 的 21 CFR 第 11 部分很像，附录 11 定义了将电子记录和电子签名视为等同 于纸质文档的标准。

This application note features guest expert Harold Woods, a senior life science operations leader with decades of experience, explaining how to integrate environmental monitoring system data into Quality Management Systems. Learn regulatory expectations, best practices for EMS–QMS integration, and how audit-ready environmental data strengthens compliance, risk management, and product quality.

设计、建造和部署洁净室设施需要跨多个学科的专业知识。以可持续的方式实施洁净室又加入了另一层复杂性，需要创新的解决方案来平衡能源效率、法规合规性和出色的运营。

医院和诊所依赖受控环境，确保药品和各类疗法的安全性。药房冷藏箱温度仅出现几度偏差，或手术室湿度骤然升高而未被及时发现，都可能导致审查不合格、产品损失，甚至危及患者安全。正因如此，越来越多的医疗机构开始采用自动化医院温度监测系统，以实时跟踪关键环境条件。

This blog explores GxP data integrity through the ALCOA++ principles, with practical insight from Vaisala GxP expert Paul Daniel. It answers common compliance questions and includes a curated recommended reading list with direct links to key FDA, EMA, MHRA, and ISPE regulatory guidance documents.