We need IQ/OQ/PQ documentation for our accreditation — does Seemoto provide this?

Yes, GMP validation support including Installation Qualification, Operational Qualification, and Performance Qualification documentation packages is included with biobank deployments. These documents are formatted to align with standard pharmaceutical and biorepository validation templates and can be reviewed alongside your internal QA team.

How does the access-controlled dashboard work for a team where some staff should only see their own storage units?

Role-based permissions allow you to assign users to specific equipment groups, so a research group only sees the freezers allocated to them while biosafety officers and QA managers retain full visibility. All logins and data access events are recorded in the audit trail for accountability purposes.

Can the system handle adding new storage units as the biobank expands without revalidation of the entire platform?

New sensors and equipment can be added to the validated platform under a change-control procedure that qualifies only the new addition rather than requiring full requalification of the existing installation. This modular approach significantly reduces the validation burden as the biobank grows.

解决方案/冷库与深冷冰箱/生物样本库温度监测

生物样本库温度监测

冷库与深冷冰箱

针对生物样本库的多区域合规监测，涵盖液氮罐、超低温冰箱以及室温环境。包含 GMP 验证支持、24/7 关键警报、长期数据保留以及面向受监管生物样本库环境的访问控制仪表板。

联系销售

查看冷库与超低温冰箱

EN12830 GDP GMP FDA 21 CFR Part 11

多区域生物样本库合规方案

生物样本库通常同时运行着截然不同的温度区间——控温洁净室、–20°C 与 –80°C 机械冰箱以及 –196°C 液氮罐。因此，单一的合规系统必须在一个经过验证的平台下覆盖所有这些区域。本方案将生物样本库的所有存储区域整合至单一的 GMP 验证监测环境中，并提供统一的仪表板和访问权限受控的数据管理。

部署方式

适用于各个区域的传感器（如用于房间的环境探头、用于机械冰箱的 PT-1000 传感器以及用于液氮罐的液氮级探头）通过公用的网关基础设施连接至统一的云平台。IQ/OQ/PQ 验证文档作为部署的一部分提供，基于角色的访问控制则根据样本库的人员结构限制仪表板视图和数据导出权限。

数据留痕与报告

符合 GMP 标准的电子记录及长期数据保留机制满足生物样本库认证机构的多年期归档要求。该平台支持生成周期性合规报告、偏差汇总以及设备确认记录，这些资料可直接提交给内部 QA 或外部审计机构，用于评估生物样本库是否符合 ISO 20387 或同等标准。

适用于医疗保健制药实验室