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Is Cosmetri GMP FDA Title 21 CFR Part 11 and EU Annex 11 compliant?
FDA Title 21 CFR Part 11 covers regulations for the management of electronic records and use of electronic signatures. Cosmetri GMP is designed for compliance with ISO:22716 covering cosmetic products only and is therefore not covered by this regulation.
EU Annex 11 goes beyond the FDA 21 CFR Part 11 to cover integrity of system operations and information stored in the system. Likewise, this regulation does not apply to cosmetics products. Nevertheless, we refer to these regulations as ‘best practice’ guidelines in how we design and implement our software and are committed to ever closer alignment with these standards.