Built for Safety. Powered by Precision.
Smart documentation and quality assurance working together to keep compliance sharp and safety systems strong.
Smart Documentation & Quality Assurance
Stay compliant, consistent, and inspection-ready with clear documentation and strong quality systems that support every step of your pharmacovigilance process.
Individual Case Safety Reports (ICSRs)
Detailed records of adverse events including patient data, drug info, and causality assessment—timeliness and accuracy are crucial.
Pharmacovigilance System Master File (PSMF)
A living document outlining your entire PV system—essential for inspections and always up-to-date.
SOPs & Work Instructions
Step-by-step operational guides that maintain process consistency—version-controlled and regularly reviewed.
Aggregate Reports (PSURs, PBRERs, DSURs)
Periodic summaries of cumulative safety data that assess the benefit-risk profile of a drug.
Risk Management Plans (RMPs)
Strategies for identifying, minimizing, and monitoring drug-related risks throughout the product lifecycle.
Safety Data Exchange Agreements (SDEAs)
Define roles and timelines for PV responsibilities between stakeholders with clear, formal agreements.
Training & Audit/Inspection Records
Documentation of staff training, audits, inspections, and CAPA tracking to demonstrate compliance readiness.
Quality Management System (QMS)
A structured framework of policies, procedures, and roles to govern and ensure PV quality.
Audits & Inspections
Independent audits and health authority inspections help identify gaps, drive improvements, and verify compliance.
Corrective & Preventive Actions (CAPAs)
A proactive approach to identifying root causes, resolving issues, and preventing recurrence.
Quality Control (QC) Activities
Ongoing data and process checks to ensure completeness, accuracy, and integrity across PV operations.
Management Review
Regular evaluations by leadership using performance indicators to enhance the PV system's effectiveness.