New MyPhileas application for computers and tablets

Description

Specifications

Parameters

Standards

New MyPhileas application for computers and tablets to remotely monitor and ensure full operations traceability. Complies with the requirements of 21 CFR Part 11.
  • Remote control of all Phileas® devices: start, stop disinfection while out of the area
  • Full traceability of data in the dissemination report: biocide batch number, environmental conditions, operator name, room details, etc.).
  • Report issued at the end of dissemination with validation of compliance or non-compliant items
  • Different user profiles and associated rights, dual identification
  • Audit trail of all operations performed with the device.
MyPhileas can configure different "zones" (rooms) with different disinfection protocols (volume, dosage, contact time, etc.). The application can be connected to several Phileas® devices to initiate the biodecontamination of an entire fleet at the same time.

The new version of the MyPhileas application now complies with GMP Annex 11 and CFR21 Part 11 (third party audit available upon request).

  • User profiles with access restrictions
  • Traceability and dissemination reports.
  • Audit Trail
  • Data Integrity

The MyPhileas v2.0.37 application is functionally compliant with the requirements of 21 CFR Part 11 and GMP Annex 11. Devea has also implemented the necessary procedures internally to substantiate the compliance of its application during future version upgrades.

Decontamination and Biodecontamination of surfaces

CFR21 Part 11
Data Integrity
EN 17-272

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