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SAE Reconciliation Software

Simplify Serious Adverse Events (SAEs) Reconciliation Operations with a customisable and GxP Validated Platfom Solution

Our eReconciliation® software allows to import and compare records side-by-side from any clinical and safety database, flags changes in source data and offers operational functions that help manage all reconciliation operations. All operations are recorded in an audit trail and can be exported in Excel files.

A Flexible SAE Reconciliation Software Designed for GxP Compliance.

Clinical Data Management Regulatory Compliance

Ethical’s software, systems and services comply with all regulations that apply to clinical data management: GxP, GAMP 5, US 21 CRF Part 11, EU GMP Vol. 4 Annex 11, ISO 27001.

Flexible Configuration for System and Database Hosting

You can choose between Ethical's Cloud-Based Hosting and Server Management or Install eReconciliation Web Application on your own Data Center

Computer System Validation Support

eReconciliation® service includes a complete Software Validation Documentation Package (Validation master plan; User Requirements Specifications; Design and Functional Specifications; Traceability Matrix; Installation Qualification (IQ); Operational Qualification (OQ); Performance Qualification (PQ); Change Management, Backup and Recovery, Users Access SOPs.

Request a Demo of the eReconciliation® Software

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



Download Ethical eReconciliation for SAE Reconciliation Dossier

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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

The SAE Reconciliation Process: A Multi-Facet Challenge

The SAE reconciliation process can be summarized in four - apparently easy - steps: retrieve and compare data, analyze the discrepancies, resolve the discrepancies ...

SAE Reconciliation Process: a multi-facet challengeREAD MORE