The quality journey for medical device companies is rarely simple. There are likely to be numerous hurdles to clear, many of which can have a bearing on how quickly a product comes to market. More often than not, the product lifecycle needs boxes to be ticked from the moment that an idea is born until the time it becomes a working device in the healthcare sector.
Orcanos integrates Design Control (Application Lifecycle Management), a formalized Quality Management System (QMS) and the keys to Regulatory Compliance in one central access point. End users can also generate data into Microsoft Office tools at any point, and either export them for e-signature in the Orcanos Document Management System or directly sign the electronic records.
Understanding and appreciating risk is an inherent part of any product lifecycle. Continuous visibility for stakeholders is key, and identified hazards must be mitigated before a product failure becomes a problem.
Orcanos audit tools integrate Risk Management into the various stages of product development and QMS processes, generating actionable data with a single click. In fact, our research has shown that companies can save up to 30 percent of the resources allocated to manual risk management by leveraging our ISO 14971 compliant software.
Paper-based QMS processes can be a bottleneck in the race to get a product to market. Orcanos replaces the traditional method of submitting required documentation with electronic forms, which can have a positive impact on both productivity and efficiency.
Our solution includes the following upgrades to paper-based quality processes:
“ORCANOS Medical provided a platform to easily deal with complexities entailed in capturing and managing of Product Requirements (System, Software, Hardware, Mechanical, etc) , Risks Management and Traceability in a highly regulated environment…”
Technical Program Manager, Fio
“Orcanos ALM allows us to build our business strategy KPI’s and see the quality of our processes and the efficiency of our program execution to meet the market demands…”
Co-Founder, Mazor Robotics
“…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…”
Combine Design Control (ALM) with quality management system and regulation in a central repository
Easily generate ready for submission documents from your database
Integrate risk into your development, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971
Define electronic signature process for a complete documents approval lifecycle
Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity…), E-sign processes, status flows, mandatory rules and permissions
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
Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability
Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents. Alerts are automatically fired once a day/week