O-Vigilance provides a web‑based dashboard that continuously syncs with the ANSM safety‑alert feed, letting regulatory, pharmacovigilance, and quality teams view, annotate, and share alerts in real time. The platform automates alert qualification, audit‑trail sharing, and statistical reporting, reducing manual copy‑paste work and supporting compliance documentation.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical and medical device companies must monitor ANSM safety alerts, but the process involves manually copying alerts from the regulator’s website, qualifying them, and distributing information to teams, which is time‑consuming and error‑prone.
Solution
O-Vigilance offers a web‑based platform that replicates the ANSM alert feed in a real‑time, editable dashboard. Users can qualify, comment on, and share each alert directly within the system, eliminating manual copy‑paste steps. The platform automatically updates with new ANSM alerts, ensuring users always have the latest information. Built‑in analytics generate ready‑to‑use statistics to support quality reporting and compliance documentation. By centralizing alert management, O‑Vigilance streamlines communication across teams and reduces the risk of missed or misinterpreted safety information.
Target Audience
Primary users are regulatory affairs, pharmacovigilance, and quality assurance teams in pharmaceutical and medical device companies that need to track and act on ANSM safety alerts.
Features
- Real‑time synchronization with the ANSM alert feed, presenting all published alerts in a single dashboard
- Inline qualification and commenting tools that allow users to annotate alerts without leaving the platform
- One‑click sharing of annotated alerts to internal teams, preserving context and audit trails
- Automated generation of statistical reports for quality and regulatory compliance
- Web‑based interface requiring no installation, accessible from any browser with role‑based access controls