What does the IQ/OQ/PQ process involve and how long does it take?

IQ confirms the system is installed as specified; OQ tests that it functions within defined parameters; PQ demonstrates consistent performance under real operating conditions. The full process typically takes two to three days on-site, and Seemoto's validation team provides all protocol and report templates aligned with GAMP 5 guidelines.

Can the system meet FDA 21 CFR Part 11 requirements for electronic records?

Yes — Seemoto's platform includes tamper-evident audit trails, role-based access controls, and electronic signature workflows that satisfy the core requirements of 21 CFR Part 11 for electronic records in pharmaceutical environments.

How does the HIS/LIMS integration work in practice?

Seemoto supports integration via standard APIs or HL7 messaging, allowing temperature alarm events and monitoring status to appear within the hospital's existing information system without requiring staff to switch applications. Integration scope and data mapping are agreed during the project specification phase.

解决方案/实时与移动监测/医院药房监测

医院药房监测

实时与移动监控

针对医院药房存储（包括药品冷藏柜、血库冰箱和受控物质专柜）的全面监测。提供 HIS/LIMS 集成、完整的 IQ/OQ/PQ 验证、24/7 关键警报以及年度再验证支持。

联系销售

查看实时与移动监测

GDP GMP EN12830 FDA 21 CFR Part 11

医院药房 GxP 验证

医院药房的 GxP 合规要求较零售药房更为严格，不仅要求对监测系统进行正式验证，还需实现与医院信息系统的文件化集成。未经验证或文件缺失的监测配置不仅面临监管合规检查不通过的风险，还可能在认证周期内导致药房运营中断。Seemoto 提供完全验证的监测基础设施，内置 IQ/OQ/PQ 文档、HIS/LIMS 集成以及年度再验证支持。

部署方式

传感器部署于医院药房的药品冷藏箱、血液冷藏箱、受控药品柜及其他任何对温度敏感的存储单元中，并通过验证性温湿度分布研究（Mapping Study）确定传感器的最佳安放位置。通过与医院的 HIS 或 LIMS 系统集成，可在现有工作流程中实现自动数据交换和报警确认。该系统通过正式的 IQ/OQ/PQ 流程进行资质确认。

数据留痕与报告

提供完整的 IQ/OQ/PQ 验证文档，涵盖每个受监控存储单元的安装确认、运行确认和性能确认。监测记录符合监管环境下计算机化系统的 GMP 附录 11 要求，包括审计追踪完整性、访问控制日志以及符合 FDA 21 cfr Part 11 的电子签名功能。年度再验证报告可确认系统持续维持良好的性能。

适用于医疗保健