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:
Orcanos CAPA system is integrated with ORCANOS e-QMS to support Medical device compliance.
Thanks to Orcanos integration with downstream elements, CAPA processes can be managed in a single tool. Irrespective of whether the undesirable situation is risk associated or the resolution itself needs an engineering change, the system links the respective QM artifacts through the Orcanos Traceability tool. This internal action then allows companies to access impact analysis data and realtime tracking.
Time is often of the essence when it comes to CAPA processes. For that reason, the Orcanos CAPA tool allows for the customization of the process and electronic forms in minutes
Our game-changing ALM solution combines design control with quality in a central repository, allowing end users to collaborate effectively.
Generate ready-for-submission documents from your database, quickly and with a minimum of fuss
Integrate risk into your development, ensure hazards are mitigated and prevent failure from happening, all in accordance with ISO 14971
Define e-sign processes (routing process) for documents approval, comply with 21 CFR Part 11.
Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity etc.), E-sign processes, status flows, mandatory rules and permissions
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
Process-critical inconsistencies such as a new risk or the discovery of outdated documents can occur at any point. Our system will alert you when this happens, with automatic notifications sent once a day or a set time each week.