A Single Platform to Manage Safety Documents and Data

Ensure optimal operational efficiency, inspection readiness, and regulatory compliance.

Content Management

Content Management supports the creation and maintenance of a Pharmacovigilance System Master File (PSMF), PV Agreements (PVA) and other safety content.

More Effective Collaboration

Easily share PV documents across internal partners across safety, quality, clinical, and regulatory, and external partners like CROs.

Audit and Inspection Readiness

Improve audit and inspection readiness with audit reporting and tracking that shows detailed changes and version history.

Strategic Decision Support

Establish an accessible, intuitive, and easily searchable source of truth to better align business processes and support strategic decisions.

Regulatory Compliance

Gain access to out-of-the-box, up-to-date support to readily comply with industry regulations such as the EMA’s PSMF requirements.

Features

Deliver real value with Content Management.

Managed Environment

Leverage a secure SaaS platform with controlled access for internal and external users to centrally manage safety content, including PSMFs, PV Agreements, and SDEAs.

Out-of-the-Box Templates

Access out-of-the-box content binder structures for PSMF and PVA with template placeholders to support audit readiness and increase compliance.

Configurable Workflows

Automatically route content for review and approval and trigger workflows based on document expiration and periodic review notification.

Comprehensive Audit Trail

Enable greater compliance with detailed audit trails to log activity throughout a document’s history.