Automate your PVA/SDEA
business processes minimizing
manual steps and outsourcing costs
Pharmacovigilance Agreements (PVA/SDEA)
A PVA is a standalone written agreement between a biopharma company and a third party which outlines the safety responsibilities and activities of each party, to enable each to establish effective ways of working and be compliant with relevant regulations. The current process for PVA is not optimal with lack of consistency, duplication, and difficulty in assembling content from various sources for traceability, audits and inspections. In the current process, PVAs are manually authored using existing templates and once reviewed and approved, meta-data is extracted manually for compliance monitoring. The current systems not provide oversight of performance and compliance. This results in inefficient utilization of resources and has the potential for compliance and audit/inspection risk.
Quartica’s PVA solution centralizing the PVA core capabilities and thus streamlining developing, implementing, maintaining, monitoring and terminating PVAs with third parties, remaining compliant with contractual obligations and regulatory requirements. It will support an automated workflow-based system for the authoring, internal and external review approval. It will ensure compliance with contractual obligations and regulatory requirements with built-in PVA reconciliation and compliance checks, oversight of KPIs for PVAs and audit trail, notification and compliance dashboard for full traceability and process compliance.
