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
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!