InnovaPrep solutions for microbiological detection in critical environments
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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.
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).
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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