Capa Medical Device


CAPA Medical Device

ORCANOS  CAPA (Corrective Action and Preventive Action), as part of Orcanos QMS, ensure regulations compliance, while automating CAPA process completely, from initiation to investigation and closure.

ORCANOS CAPA system includes:

  • Electronic, secured and centralized web-based system
  • Tractability to other quality processes, such as FMEA, ECO, Complaints, Training, Verification etc.
  • Corrective and Preventive Action Management
  • Root-cause management and action planning
  • Prioritization
  • Verification of Effectiveness
  • Smart dashboards
  • Workflow and e-sign automation
  • 21 CFR Part 11 compliant


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