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05QMS Intel-AI

QMS Intel-AI

Turn quality data into action.

Launch app

Open quality actions — controlled register

CAPA-2026-118 · raised from regulatory update REG-2026-0192

  • 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

PV Command Center

See the PV system. Know what needs attention.

Explore QPPV Oversight