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Orcanos QMS System, an introduction …
Medical device companies must modernize their quality management processes to keep up with the rapid pace of digital innovation in healthcare. Orcanos Quality Management System (QMS) software offers a comprehensive solution that replaces outdated paper-based systems and spreadsheets.
Orcanos Quality Management System (QMS) 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.
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.
The Orcanos e-QMS user-friendly platform includes professional tools that can build a centralized QMS within hours.
As an example:
- Electronic forms with e-Sign capabilities
- Tractability tool
- Support for ISO 13485 and ISO 9001
- Automatic work flows for QMS forms, including CAPA and ECO
- A professional dashboard to track and control information
- Compliance AI engine that monitors data in real-time
Document Control Software System
Orcanos e-DMS is a comprehensive document control software system designed to enable end-users to create, trace, search, archive, and approve all medical device product launch documentation at every stage.
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.
Furthermore, Orcanos e-DMS supports all document types, including but not limited to user manuals, procedures, required forms, work orders, instructions, product specifications, inspection test protocols, and non-conformity reporting.
ISO 14971: Risk Management
Risk management is a crucial aspect of any effective QMS, particularly in the medical device sector, where it falls under the purview of ISO 14971.
Applying good risk management practices throughout the product lifecycle is crucial, beginning with research and development, continuing through manufacturing, and even after entry into the marketplace. It's important to note that risk management doesn't end when a product is sold, and post-marketing observation is necessary to identify any quality-related issues such as CAPA or product recalls due to safety concerns.
Read MoreRisk Automation
Automating the entire risk management system includes features such as an Risk Level calculation method, setting up probability based on the hazardous situation, and more.
Supports FMEA Types
Define PFMEA, UFMEA, DFMEA easily, setup different calculations and different methodology based on the FMEA type
Hazard Identification
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 risks or ensure compliance. Importantly, a perceived lack of quality by third parties can have a negative impact on the brand itself.
Change Management (ECO)
Orcanos Engineering Change Order (ECO) management system is another vital module of the quality process. It enables companies to 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
Complaint Handling
While customer complaints may be an unwelcome aspect of the quality process, effectively managing and resolving them in a timely manner is crucial. Proper complaint management can also minimize the chances of product recall and damage to brand reputation, which can have a significant financial impact on current and future business opportunities.
Orcanos Complaint Management System addresses these concerns and helps ensure that companies can move forward confidently. The software supports ISO 13485 post-surveillance procedures, with a focus on complaint handling and labeling control.
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CAPA 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
Design Control
Fully Integrated
Quality Management
Easy Customization
Regulations
Industry-Based
What our client say about us
Igor Stankovski
Technical Program Manager, Fio
The Orcanos medical ALM solution provides us with a platform to easily deal with complexities entailed in capturing and managing product requirements (system, software, hardware, mechanical, etc.), risks management and traceability in a highly regulated environment.
Eli Zehavi
Co-Founder, Mazor Robotics
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…
Oren Tamari
CEO, Upnride
…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…
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