Pharmacovigilance & Post-Market Surveillance

Qualio's Postmarket Surveillance and Pharmacovigilance software is a connected quality management solution designed for life sciences companies — including pharmaceutical, medical device, and medtech organisations — that need total visibility and control over their products once they reach the market. The platform addresses the critical challenge that getting a drug or device to market is only the beginning: hundreds of products are recalled annually, resulting in hundreds of millions of dollars in revenue loss, and disconnected manual tools make it impossible to spot trends or maintain a full picture of market performance.

Qualio solves this by providing a unified, data-driven environment where complaints, adverse effects, feedback, and continuous improvement opportunities can all be monitored, acted upon, and traced end-to-end. Automated triggers kick off quality management workflows in response to market events, and detailed analytics help teams identify and address issues before they become harmful.

Third-Party Integrations

• Connect Qualio to CRM and ticketing systems such as Salesforce, Zendesk, Intercom, and HubSpot
• Automatically trigger complaint management workflows in Qualio as postmarket complaints are logged in external systems
• Drive closed-loop actions to completion to keep products compliant and customers satisfied

Connected Quality Data

• Build, collaborate on, and distribute key PMS and pharmacovigilance documents — including SOPs, CERs, RMPs, and PSURs — in a single source of truth
• Connect product data using system links and centralised data points such as tickets and customer records
• Pull tickets from design tools like Jira and GitHub into Qualio to inform design updates and continuous improvement activities

Smarter Workflow Actions

• Respond to market events in real time with automatic prompts and reminders
• Shape bespoke workflows to collaboratively manage adverse effect investigations, CAPAs, health authority notifications, and more
• Pull key data including batch numbers, suppliers, materials, and departments into forms and workflow actions for complete traceability

Product Insights and Analytics

• View detailed quality histories by product, covering past CAPA actions, design updates, procedural changes, and non-conformance records
• Spot product trends and weaknesses early before they escalate
• Demonstrate total control and traceability to auditors and inspectors

Qualio's postmarket surveillance and pharmacovigilance capabilities sit within a broader eQMS platform that also covers design control, risk management, training management, change control, audit management, CAPA and NCR management, supplier management, and compliance management — making it a comprehensive solution for life sciences quality teams seeking audit readiness and long-term market success.