Certifications & Standards

MyBlueLabel Compliance Services A/S certifications and standards.

ISO 9001:2015 (certified)

EU GDPR compliant

ISO 27001 compliant

ISO 13485 : 2016 compliant

ISO 14971 : 2019 compliant

In addition, the application is hosted on Microsoft Azure which has the following certifications. To name a few:

ISO 27001

ISO 9001

GxP (FDA 21 CFR Part 11)

EU GDPR

Features that ensure fast and intelligent compliance:

• Electronic Signature (US Part 11 / EU Annex11)

• Business Intelligence Dashboards

• API External Integration

SYSTEM VALIDATION & CERTIFICATIONS

• ISO 9001: 2015

• GAMP5 – A Risk-Based Approach to Compliant GxP Computerized Systems

• FDA 21 CFR Part 11

• EudraLex Annex 11