Orcanos - Healthcare Quality Management System
Adhere to strict MDR/FDA regulations and ISO quality standards by eliminating paper-based QMS processes.
As healthcare continues to evolve, medical device companies need to ensure that their quality management processes can keep up with the fast pace of digital innovation. Business optimization strategies must now align with the technology available, replacing archaic paper-based systems and spreadsheets with tools that provide a single view of the relevant information.
Orcanos Quality Management System (QMS) is that tool. Our QMS software holds all of the required data points for compliance, controlling all of the quality processes in a single access point. This focused view enables companies to not only eliminate the paper trail in the quality journey but also allows an organization the insights to adhere to strict FDA regulations and established ISO quality standards.
A key to compliance in the digital age is the removal of paper-based quality information and the integration of automated and optimized solutions.
Required reporting elements such as e-DMS, e-DHR, Complaints Management, FMEA Risk Management, CAPA, ECO, Non-Conformities, Engineering for Verification and Validation (which includes Requirements Management, Test Management and Defect Tracking) can be monitored in a single system.
Removing multiple QMS channels means that companies can quickly ensure that products meet regulations and quality standards.
The Orcanos e-QMS platform is both easy to use and includes professional tools that build a centralized QMS within hours, such as:
- Electronic forms with e-Sign capabilities
- Tractability tool
- Support for ISO 13485 and ISO 9001
- Automatic work flows for QMS forms, including but not limited to CAPA and ECO
- A professional dashboard to track and control information
- Compliance AI engine that monitors data in real-time
Orcanos e-DMS is an all-in-one document control software system that has been designed to allow end users to create, trace, search, archive and approve all documentation that is related to every stage of a medical device product launch.
The e-DMS ensures that documents relating to the planning, design, development, manufacturing and service of a particular product can be quickly accessed, increasing the effectiveness of quality processes and reducing the time to market.
In addition, Orcanos e-DMS supports any document type, including but not limited to user manuals, procedures, required forms, work orders or instructions, product specifications, inspections test protocols and non-conformity reporting.ISO 14971: Risk Management
An important and critical part of any effective QMS is risk management. In the medical device sector, this falls under the preview of ISO 14971.
The application of good risk management practices is an integral part of the product lifecycle, starting with research and development and continuing through manufacturing and eventual entry into the marketplace. Risk management does not end when a product is sold, which means that post-marketing observation for any quality-related issues such as CAPA or product recalls due to safety concerns must be taken into account.Risk Automation
Automate the entire risk management system, such as Risk Level calculation method, automatic setup of probability based on the Hazardous situation, and more.
Define PFMEA, UFMEA, DFMEA easily, setup different calculations and different methodology based o n the FMEA type
The ability to identify risks or real-world problems in a product or process is a key aspect of the quality journey. Without these insights, companies may be unable to mitigate potential risk or ensure compliance. Importantly, a perceived lack of quality by third parties can have a negative impact on the brand itself.
Another module that forms a vital part of the quality process, Orcanos Engineering Change Order (ECO) management system means that companies can digitally document and control ongoing change processes within the product lifecycle.
Elements such as Standard Operating Procedures (SOPs) and design specs, for example, can be monitored for pain points, thereby enhancing a company’s productivity levels
Customer complaints are an unwelcome part of the quality process, being able to effectively manage and solve them in a reasonable time frame is critical. Complaint management can also limit the chances of product recall and damage to brand reputation, two factors that can have a significant financial impact on current and future business opportunities.
Orcanos Complaint Management System alleviates these concerns and ensures that companies can continue on their path. The software supports the ISO 13485 post surveillance procedure, with a focus on complaint handling and labeling controlCAPA Management
- Powerful customization tools, simple templates.
- Support a wide variety of field types.
- Build workflow routing for electronic signature (Part 11 Compliance)
- Setup traceability between different e-forms
- Setup form logic such as mandatory rules
- Access control for Add/Edit/View to show/ hide form elements.
- Integrate filters into field values.
- No coding is required, drag and drop design