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Manage Audit Trail and ensure GxP Quality

Ensure compliant tracking and documentation of all operations performed during reconciliation and provide secure audit trail to inspectors at any time.

Reconciliation in Clinical Data Management usually involves several team members and consists in successive operations.

eReconciliation® allows to track chronologically every single operation performed within the system and display results in a secure 21 CFR Part 11 compliant audit trail that can easily be extracted and provided to auditors and inspectors.

Manage Audit Trail and Ensure GxP QA

 

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eReconciliation® features: Manage Reconciliation Operations with Workflows

The eReconciliation® software solution offers operational features that help manage all Safety Data Reconciliation-related operations such as task assignment and workflow, with helpful functionalities in case of staff turnover and outsourcing.

Manage Reconciliation Operations with WorkflowsREAD MORE

eReconciliation® features: Automatically Detects and Flags changes/ SAE discrepancies

With eReconciliation®, users can easily detect updates in real time and keep reconciliation operations ongoing during the course of the trial, saving valuable time on submission preparation date.

Detect SAE discrepanciesREAD MORE

SAE Reconciliation Process Checklist Download

Download a checklist that describes every step of the SAE Data Reconciliation Process. This is an essential document for all Pharmacovigilance professionals to better plan and manage the AE Reconciliation operations at their studies.

SAE Reconciliation ChecklistREAD MORE