Define quality indicators, alert and action limits, and review cadence
QUALITY MONITORING
Quality Monitoring
We review change impact, performance drift, deviations, CAPA, and quality indicators on a recurring cadence.
SCOPE OF WORK
Scope of work
Before contracting, we confirm the current state and responsibility boundary, then fix only the necessary work in scope.
Connect changes, deviations, nonconformities, complaints, and CAPA
Review performance trends, drift, and process variation
Run periodic quality reviews and track prioritized actions
KEY DELIVERABLES
Evidence that remains
We prioritize the connection between requirements, execution, results, and approval over document names.
WORKFLOW
Workflow
We review each stage before moving forward and retain unresolved items in a controlled action register.
- 01
Onboard
Confirm data sources, owners, cadence, and alert criteria.
- 02
Collect routinely
Review lot, inspection, deviation, change, and complaint data on one cadence.
- 03
Assess impact
Separate individual events from cumulative trends and prioritize action.
- 04
Track action
Track owners, due dates, and completion evidence into the next review.
RESPONSIBILITY BOUNDARY
Conditions and responsibility boundary
Quality monitoring does not replace certification or regulatory authorization. Trova Health operates status and action evidence against approved criteria.