Workflow States and Routing

Once a case is booked in, it doesn’t simply sit in a database waiting to be looked at whenever convenient — it moves through a defined sequence of workflow states, and the database itself tracks and enforces that movement. A typical sequence runs something like: initial data entry, medical/coding review, quality check, and final closure — with the exact terminology and specific state sequence varying somewhat by organisation and platform, but the underlying logic of a case having a trackable, current status shared across essentially every implementation.

Routing determines who a case goes to at each stage, and it’s rarely a simple round-robin assignment. A case flagged as potentially serious, or one involving a complex multi-drug scenario, might route specifically to a more senior medical reviewer rather than the general processing queue. An organisation with reviewers holding specific therapeutic area expertise might route oncology cases differently from cardiology cases. The routing logic itself is a meaningful piece of an organisation’s quality system, not an incidental database feature.

This workflow tracking connects directly and consequentially to Module 6’s SUSAR content: a case determined to be a SUSAR carries a hard regulatory clock — 7 days for fatal or life-threatening cases, 15 for other serious ones — and the database’s workflow state tracking is precisely the mechanism that keeps that clock visible, monitored, and enforced across every stage of processing, rather than relying on someone remembering a deadline manually. A case that sits too long in any single workflow state, particularly for a SUSAR, is a genuine compliance risk, not just a processing delay.

This is also exactly why workflow state tracking is a standard target of both internal quality audits and external regulatory inspections: an inspector reviewing a company’s PV system will commonly pull cases and check how long each spent in each workflow state, specifically looking for cases that sat too long anywhere in the process, especially expedited-reporting-eligible ones. The database’s workflow tracking isn’t just an operational convenience — it’s the auditable evidence trail that a defensible PV system depends on.