Traceability

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URL: https://devea-environnement.com/en/our-services/traceability-data-integrity/

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en

Traceability

zh-Hans

数据可溯性

Content

en

When were the latest bio-decontaminations carried out in this room? Where is the diffusion traceability data?
Is the data integrity compliant with requirements? What was the last maintenance performed on this Phileas® device?

Devea has developped MyPhileas a unique application for computers and tablets:
  remote control of all Phileas® devices: start, stop a disinfection while being outside the zone
  complete data traceability on the diffusion report: biocide batch number, environmental conditions, operator name, room details, etc.)
  report published at the end of the diffusion with  compliance validation or non-compliant elements
  different user profiles and associated rights, double identification
  audit trail of all operations performed with the device
MyPhileas can set up different “zones” (rooms) with distinct disinfection protocols (volume, dose, contact time, etc.). The app can connect to several Phileas® devices, to start the biodecontamination of a whole fleet at the same time.

Know more

The new MyPhileas application version is now compliant with GMP Annex 11 as well as 21 CFR Part 11 (third party audit available upon request).
  User profiles with access restrictions
  Traceability and diffusion reports
  Audit trail
  Data integrity
As stated in the conclusion of the audit report, “the MyPhileas v2.0.37 application is functionally compliant with 21 CFR Part 11 and GMP Annex 11 requirements. Devea has also put in place the necessary procedures internally to justify their application’s compliance during future version upgrades.”
Are you looking for a disinfection management app compliant in regulatory context? Contact us to see how MyPhileas can be fit for your operations!

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zh-Hans

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这个房间最近一次生化消毒是什么时候进行的？扩散溯源数据在哪里？
数据完整性是否符合要求？最后一次对这台 Phileas® 设备进行的养护是什么？

Devea 开发了 “MyPhileas”，一款适用于计算机和平板电脑的独特应用程序：
  远程控制所有 Phileas® 设备：在作业区外启动、停止消毒任务
  完整的扩散报告数据可追溯性：消毒剂批次号、环境条件、操作员姓名、房间详细信息等
  扩散结束时发布报告，验证合规性或不合规项
  不同的用户配置和其关联的权限，双重身份验证
  对设备执行的所有操作进行审查追溯
MyPhileas 可以为不同的“区域”（房间）配置不同的消毒方案（处理量、剂量、接触时间等）。该应用程序可以连接多台 Phileas® 设备，同时启动整个设备群的生化消毒工作。

了解更多

新的 MyPhileas 应用程序版本现在符合GMP附件11和21 CFR第11部分（可随需提交第三方审计）。
  具备访问限制的用户配置
  可追溯性和扩散报告
  审计追溯
  数据完整性
正如审计报告的结论所述，“MyPhileas v2.0.37 版本应用程序在功能上符合21 CFR第11部分和GMP附件11的要求。Devea还在（组织）内部设置了必要的（工作）流程，以在将来的版本升级中达成其应用程序的合规性。”
您是否正在寻找一款符合监管条件的消毒工作管理应用程序？请联系我们，了解 MyPhileas 如何满足您的操作！

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