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Home / GxP Compliance

SAE Reconciliation GxP Quality and Compliance

eReconciliation® Solution: Your Guide to GxP Compliance and Oversight for Safety Data Reconciliation 

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

Ethical software design 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.

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Integrated Validation Documentation and Support

Ethical’s software, systems, and services for Clinical Committee Management 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 Services, the full GAMP 5 validation documentation package and support.

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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)

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Download Your SAE Reconciliation Handbook (16 pages)

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



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SAE Handbook Download

Download your FREE practical guide on how to reconcile safety data collected from various sources and stored in more than one databases.

Download your complete safety data reconciliation handbookREAD MORE

Clinical Safety Glossary

A list of terms and definitions related to Serious Adverse Events, adverse event data management and safety and clinical databases SAE Reconciliation.

Check Now the Safety Data Reconciliation GlossaryREAD MORE

Pharmacovigilance Regulations

The quality of safety data collection and reporting is paramount to the establishment of a drug safety profile. Here are helpful links to the EMA and FDA regulations addressing those concerns.

Safety Data Reconciliation: check now EMA and FDA Regulations & GuidelinesREAD MORE