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eDSMB® GxP Quality and Compliance

Your Guide to GxP Compliance and Management of Data Safety Monitoring Boards

Ethical’s approach to quality, compliance, and privacy is simple: be expert, be thorough. That is why our business processes, systems, and services are compliant with all appropriate regulations: GxP, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, EU General Data Protection Regulation (GDPR).

Certified ISO-IEC 27001 Systems, Services and Data Processing

The DSMB software and the associated services are based on a hardware/software and organizational structure that ensures compliance with the ISO/IEC 27001 Information Security Management System (ISMS) requirements and security controls. Ethical's parent company GM Servizi is yearly audited by an authorized ISO 27001Certification Authority

Integrated Validation Documentation and Support

eDSMB® ’s software, systems, and services for Data Safety Monitoring Boards comply with all regulations that apply to EA: GxP, GAMP 5, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11.
Ethical provides, as an integrated component of our eDSMB® Services, the full GAMP 5 validation documentation package and support.

GDPR - EU General Data Protection regulation Compliance

Ethical GmbH is committed to ensuring the security and protection of the personal information and to provide a compliant and consistent approach to data protection. We have a robust and effective data protection program in place which complies with European Union General Data Protection Regulation (EU-GDPR)

Download Your DSMB-DMC Complete Handbook

We are EU-GDPR compliant: Your Data will never be used improperly



dsmb handbook

DSMBs-DMCs
Complete Handbook

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