CAPA Management System

Complete automation of CAPA process in Orcanos QMS

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

What is CAPA?

Corrective and preventive action also called CAPA are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice GMP and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence for corrective action or to prevent occurrence for preventive action

Integrated Quality Management System

Orcanos CAPA system is integrated with ORCANOS e-QMS to support Medical device compliance.

Whether it has risk associated, or resolution requires an engineering change, Orcanos links the quality management artifacts using Orcanos Traceability tool and provides impact analysis and better tracking.


CAPA Management System
CAPA Management Software

Fully Customizable CAPA Form

Customize CAPA process and electronic form in minutes

No More Paper Work


combine Design Control with quality and regulation in a central repository for better collaboration

Document Generator

Easily generate ready for submission documents from your database

Integrated Risk Management

Integrate risk into your development, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971

Electronic Signature

Define e-sign processes (routing process) for documents apporval, comply with 21 CFR Part 11.

Fully Customizable

Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity…), E-sign processes, status flows, mandatory rules and permissions 

Personal Dashboards

Build custom reports and charts to track cross-projects/cross-department reports, such as requirements traceability, test run results, risk status, CAPA and more


Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability

Realtime Alerts

Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents. Alerts are automatically fired once a day/week



8 Tozeret Ha'aretz Street
Tel Aviv, Israel

Copyright © Orcanos, All rights reserved. | Privacy policy | Terms of use