TechAppForceHigh-stakes industries
Clinical trial supply deviation review
Coordinate shipment exceptions, site impact and quality review with a traceable decision record.
Illustrative coordination workflow only. It is not a validated GxP system and does not make product-release decisions.
- In transit
- Exception raised
- Evidence gathered
- Quality reviewApproval
- Decision recordedApproval
- Follow-up closedDone
The problem
What goes wrong today
A shipment temperature alert or site delivery exception can involve a batch, several trial sites and multiple teams. Operations need to gather the evidence, understand what is affected and route a documented decision to the right reviewers.
How it runs on TechAppForce
A day with it, step by step
Amber steps wait in a person's work inbox; everything else moves on its own.
- An exception is receivedA coordinator records a shipment alert and links it to the batch, destination site and available evidence.
- Site impact is checkedOperations records which sites and kits may be affected and assigns each follow-up check.
- Evidence is assembledCarrier documents and event readings are linked to a single exception record.
- Quality reviews the caseQuality reviewThe assigned reviewer records a decision under the organisation’s own validated procedure.
- Follow-up is visibleA queue and report show the decision, owner and remaining actions for the supply team.
What gets configured
Settings you can read, change and release
No code for any of this, unless a rule truly needs it.
Records 5
- Trial supply batch4 fields + history, files, comments
- Shipment4 fields + history, files, comments
- Temperature event4 fields + history, files, comments
- Site impact review3 fields + history, files, comments
- Quality decision4 fields + history, files, comments
Stages 6
- In transit
- Exception raised
- Evidence gathered
- Quality reviewdecides
- Decision recordeddecides
- Follow-up closed
Automatic 3
- NotifyA shipment exception opens a review and notifies supply operations and quality
- WorkflowUnassigned site-impact checks are added to the operations work queue
- ScheduleA daily report lists open shipment exceptions by age, batch and destination
Screens and reports 5
- Shipment exception queue with batch, site and current review owner
- Evidence form linked to event readings and carrier documents
- Site impact and quality decision review with comment history
- Open shipment exceptions and outstanding site checks
- Internal review pack linking event evidence to recorded decisions
Who approves, in detail
Supply operations gathers the shipment evidence and site impact. A quality reviewer records the decision and any follow-up. The page illustrates coordination only; the organisation’s validated procedures govern the regulated record and release decision.
When the rules change
Bring your version of this.
A change a few months in is a reviewed release, not a rebuild. We will configure your version with you in a demo.
Release: Shipment: exception review
- Developmentmake the change
- QAreview the diff, test it
- Productionpromote the release