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05Quality Intelligence
COMPLIVISE Quality
Simple quality management designed for pharmaceutical teams.
Launch appOpen quality actions — controlled register
CAPA-2026-118 · raised from regulatory update REG-2026-0192
ActionOwner
Update SOP-PV-014, section 6
Literature screening criteria to reference new warning
In review cycle
S. Iyer · due 29 Aug
Retrain 14 assigned users
Triggered on document release, read-and-understood
Scheduled
Pending SOP release
Effectiveness check at 90 days
Sample 20 screening decisions post-implementation
Planned
A. Kulkarni · due 27 Nov
Actions stay linked to the change that created them until closure evidence is recorded. · Illustrative product experience.
How the work moves, end to end.
- What enters
- Controlled documents, deviations, complaints, change requests, training records and audit findings.
- What is assessed
- Root-cause analysis, risk and impact evaluation, review cycles and effectiveness-check planning.
- What action follows
- CAPA execution, change control, training assignment, document release and audit preparation.
- What evidence remains
- Version history, review and signature records, action ownership, effectiveness outcome and closure date.
What it does.
- Controlled documents
- Version control
- Review cycles
- Electronic-signature capability
- Training workflows
- Change control
- Deviations
- CAPA
- Root-cause analysis
- Effectiveness checks
- Complaints
- Audit preparation
- Open-action visibility
- Inspection readiness
- Quality analytics
Next layer
COMPLIVISE Oversight
One view of the pharmacovigilance system for the QPPV.