Late reporting
Without a simple channel, deviations are reported late, when evidence is gone.
Pharmaceutical & Health
Deviation & CAPA management
Centralize reporting, analysis, and CAPA tracking in a structured, traceable workflow for your audits.
Deviations get lost in emails
Informal reporting, analysis in Excel files, untracked actions: compliance is impossible to prove.
Untracked actions
CAPAs are listed but no one knows who owns them or whether they are done.
Poor management visibility
No dashboard to prioritize recurring deviations and measure improvement.
A deviation → CAPA → proof workflow
The MVP structures every deviation: reporting, root cause analysis, action plan, and effectiveness validation.
Simplified reporting
Short form, attachments, and automatic notifications to owners.
Structured workflow
Mandatory steps: analysis, CAPA, action plan, and effectiveness verification.
Dashboard and alerts
View of open deviations, overdue CAPAs, and trends by category.
What you gain in 8 weeks
An operational CAPA workflow and traceable deviations from the first month.
How we deliver it
From paper process to digital workflow
We adapt the workflow to your current SOP and test it on real deviations.
01
SOP workshop
Mapping of existing process and definition of roles/mandatory steps.
02
Workflow MVP
Development of form, workflows, and dashboard.
03
Test on pilot deviations
Reporting and processing of real deviations, adjustments, and QA handover.
Structure your deviations and CAPAs
We’ll show you how a deviation management MVP eases your audits in 20 minutes.