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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.

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Fully Customizable CAPA Form

Customize CAPA process and electronic form in minutes.

  • Add custom fields
  • Mandatory rules
  • Access control
  • Traceability rules
  • Alerts and notifications
  • Automation, e-Sign and workflow
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No More Paper Work

ALM+QMS

ALM+QMS

Combine Design Control (ALM) with quality management system and regulation in a central repository

Document Generator

Document Generator

Easily generate ready for submission documents from your database

Integrated Risk Management

Integrated Risk Management

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

21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

Define electronic signature process for a complete documents approval lifecycle

Easy Customization

Easy Customization

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

Dashboards And Analytics

Dashboards And Analytics

Better tracking and control with custom reports and charts builder, to track projects progress and quality procedures status, such as requirements traceability, test run results, risk assessment, CAPA and more

End To End Traceability

End To End Traceability

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

Realtime Alerts

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

Your virtual Auditor

Your virtual Auditor

Use Orcanos Compliance Engine to get a real-time audit of your projects, anywhere, anytime!

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Your next electronic audit with Orcanos

Assure your success……

Schedule Demo
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