A monitoring workflow for product findings, market evidence, recommendations, audit dates, follow-up cycles, and surveillance reporting.
Executive Summary
This blueprint describes how an organization can move from scattered manual tracking to a governed workflow with clear ownership, document evidence, approval status, reminders, and management visibility. It is intended as a conversation starter for process review, solution design, and implementation planning.
Business Problem
Post-market monitoring loses control when findings, recommendations, attachments, audit dates, and next follow-up cycles are disconnected from product registration records.
Proposed Workflow
Proposed Modules
Surveillance Register
Supports ownership, status visibility, review evidence, and operational follow-up.
Product Linkage
Supports ownership, status visibility, review evidence, and operational follow-up.
Finding Matrix
Supports ownership, status visibility, review evidence, and operational follow-up.
Recommendation Tracker
Supports ownership, status visibility, review evidence, and operational follow-up.
Attachment Evidence
Supports ownership, status visibility, review evidence, and operational follow-up.
Surveillance Reporting
Supports ownership, status visibility, review evidence, and operational follow-up.
Mockup Preview
The mockup illustrates dashboard summary cards, registration lists, detail records, approval timeline, and document checklist patterns.
Regulatory Workspace
42 Active Registrations
12 Pending Review
8 Renewal Alerts
Benefits
Clear link between registration and monitoring.
Better visibility of findings.
Improved follow-up discipline.
More reliable surveillance reporting.
Customization Considerations
This blueprint is intended as a starting point for discussion rather than a fixed application design. Liberty Jaya adapts the workflow to fit each organization’s structure, compliance obligations, document standards, and reporting needs.
Related Blueprints
Product registration often depends on scattered email threads, Excel trackers, shared folders, and manual reminders, making dossier readiness, submission status, and renewal control difficult to manage.
Product approval becomes difficult to control when requests, variants, certificates, expected launch dates, reviewer decisions, and registration status are managed separately.
Consumer safety cases become difficult to govern when case evidence, reviewer decisions, release status, closure records, and periodic reports are handled manually.
Contact CTA
Liberty Jaya can help map the process, identify document evidence, design approval governance, and prepare implementation scope.