The identification and integration of Corrective and Preventative Actions is a critical part of the quality process. Otherwise known as CAPA, they are normally a series of improvements that will both eliminate the root causes of non-conformities or undesirable situations and prevent their recurrence. A well-established concept with the principles of Good Manufacturing Practice (GMP) and ISO business standards, CAPA processes are usually undertaken as part of regulatory compliance and overall hazard analysis within the product lifecycle. 

Orcanos CAPA tools are part of the Orcanos Quality Management System (QMS) and ensure that an organization is not only compliant with regulatory requirements but addressing recurring quality issues in a timely fashion. Our software automates the CAPA process completely, from initiation through to investigation and, ultimately, closure of an identified issue.

ORCANOS CAPA system includes:

• Electronic, secured and centralized web-based system
• Traceability  to other quality and regulatory processes, including but not limited to  FMEA, ECO, Complaints, Training and Verification.
• 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 compliance