A growing suite of pharmacovigilance applications — from case processing, ICSR and signal management to aggregate reporting, literature surveillance, PSMF, vendor oversight and quality operations — each Part 11-aware, audit-trailed, and physician-built. Licence a single module or the full suite.
Every write passes through controlled procedures with an append-only audit trail. Closed records are read-only unless formally reopened with a reason.
Processing, medical review, quality review and oversight are separated through role-based access, so the workflow enforces who can do what.
Each tool stands alone. Take one module for a focused need, or bundle the suite as your operation grows.