QUALITY MONITORING

Quality Monitoring

We review change impact, performance drift, deviations, CAPA, and quality indicators on a recurring cadence.

RECOMMENDED FOROrganizations that need one operating rhythm for post-release changes, deviations, complaints, and performance indicators

Scope of work

Before contracting, we confirm the current state and responsibility boundary, then fix only the necessary work in scope.

01

Define quality indicators, alert and action limits, and review cadence

02

Connect changes, deviations, nonconformities, complaints, and CAPA

03

Review performance trends, drift, and process variation

04

Run periodic quality reviews and track prioritized actions

Evidence that remains

We prioritize the connection between requirements, execution, results, and approval over document names.

01Quality indicator definitions
02Change and CAPA register
03Monthly quality review
04Management review operating plan

Workflow

We review each stage before moving forward and retain unresolved items in a controlled action register.

  1. 01

    Onboard

    Confirm data sources, owners, cadence, and alert criteria.

  2. 02

    Collect routinely

    Review lot, inspection, deviation, change, and complaint data on one cadence.

  3. 03

    Assess impact

    Separate individual events from cumulative trends and prioritize action.

  4. 04

    Track action

    Track owners, due dates, and completion evidence into the next review.

Conditions and responsibility boundary

Quality monitoring does not replace certification or regulatory authorization. Trova Health operates status and action evidence against approved criteria.

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