Ensuring End-to-End Data Traceability and Compliance with PvEdge

Problem Statement

Pharmacovigilance (PV) operations involve multiple systems, stakeholders, and complex data exchanges. 
Maintaining traceability, ensuring audit readiness, and achieving regulatory compliance across these systems often becomes: 

  • Cumbersome and fragmented due to disconnected workflows
  • Error-prone, leading to potential compliance gaps
  • Difficult to audit, lacking visibility into data changes and case lifecycle activities

These challenges increase the risk of regulatory non-compliance and inefficiencies in safety data management. 

Solution: PvEdge Suite

PvEdge provides a centralized and validated environment designed to establish end-to-end data traceability and compliance across all Pharmacovigilance operations. 

Key Functionalities

Comprehensive Audit Trail

Captures every data modification, user activity, and system event across the case lifecycle.
Provides real-time audit reports to support regulatory inspections and internal QA audits.

Automated Compliance Validation

Performs E2B(R3) compliance checks automatically during data intake and submission stages.
Ensures every case meets global regulatory data standards before transmission.

Configurable Workflows

Enables customized workflows for case processing, review, and approval.
Supports alignment with SOPs and organizational compliance policies.

How it Benefits

Efficient Case Management:
End-to-end visibility across PV operations
Data Privacy and Compliance
Improved data integrity and regulatory confidence
Reduced audit preparation time through automated traceability
Inadequate testing
Proactive compliance monitoring reducing manual oversight

Business Impact

Organizations leveraging PvEdge experience: 

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100% traceability across safety data and workflows

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Enhanced posture with built-in audit and validation controls

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Streamlined inspection readiness, ensuring transparency and accountability

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