Post-Market Surveillance Management System
Post-market monitoring loses control when findings, recommendations, attachments, audit dates, and next follow-up cycles are disconnected from product registration records.
A case workflow for managing consumer safety reports, complaint evidence, review approval, release, closure, and periodic 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
Consumer safety cases become difficult to govern when case evidence, reviewer decisions, release status, closure records, and periodic reports are handled manually.
Proposed Workflow
Proposed Modules
Safety Case Register
Supports ownership, status visibility, review evidence, and operational follow-up.
Evidence Attachment
Supports ownership, status visibility, review evidence, and operational follow-up.
Review Workspace
Supports ownership, status visibility, review evidence, and operational follow-up.
Approval Check
Supports ownership, status visibility, review evidence, and operational follow-up.
Case Status Tracking
Supports ownership, status visibility, review evidence, and operational follow-up.
Periodic 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
Controlled case intake and review.
Clear safety case ownership.
Better evidence retention.
More reliable periodic safety 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
Post-market monitoring loses control when findings, recommendations, attachments, audit dates, and next follow-up cycles are disconnected from product registration records.
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.
Audit programs become difficult to control when schedules, findings, owners, evidence, and closure status are not managed through a structured workflow.
Contact CTA
Liberty Jaya can help map the process, identify document evidence, design approval governance, and prepare implementation scope.