Deviation
Registration, severity, cause and further follow-up.
QUALITY AND QMS
Quality work connected to operational reality
Genitus is being developed to connect deviations, actions, vigilance, recall, history and reporting to the same objects and events used in the milk bank’s operational work.
Request a demo- Deviation
- CAPA
- Recall
- Report
A CONNECTED QUALITY FLOW
From event to documented follow-up
The areas are connected, but do not always follow a fixed order. One event can trigger one or several tracks for assessment, action, documentation and reporting.
- DeviationRecord and assess
- CAPACorrect and prevent
- VigilanceCapture relevant signals
- RecallScope and trace
- Audit trailDocument the history
- ReportingAssemble the evidence
DeviationRecord and assess
CAPACorrect and prevent
VigilanceCapture relevant signals
RecallScope and trace
Audit trailDocument the history
ReportingAssemble the evidence
CENTRAL AREAS
One quality page – several linked work areas
CAPA
Actions, responsibility, deadlines and an effectiveness check.
Vigilance
Signal, assessment, notification and relevant documentation.
Recall
Scope, affected units, blocking and forward tracing.
Audit trail
Who, what, when and changes in a controlled context.
Reporting
A shared basis for follow-up, learning and oversight.
LINKED TO TRACEABILITY
The quality case points back to what actually happened
Affected products
Identify the boxes, batches and remaining milk affected by the case.
Affected recipients
Identify recipient infants to whom milk has already been delivered or administered.
Documented basis
Link assessments, decisions and tasks to the relevant events.
FOLLOW-UP AND LEARNING
From action to effectiveness check
A quality system should do more than register a case. It should make responsibilities, deadlines, actions, decisions and learning visible over time.
Responsibility
A clear owner and task.
Follow-up
Status, deadline and documentation.
Effectiveness check
Verify that actions work.
Learning
Turn experience into improvement.
Would you like to discuss the quality system and your needs?
We start from the milk bank's needs, practice and scope.