ALM AND QMS
Integrating Design Control (ALM) with a quality management system and regulatory compliance in a central repository. A simple, Part 11 validated system that satisfies the needs of the QA RA and R&D departments, supports embedded products – Software, Hardware, and automates End to end traceability across entities. At any point, Orcanos enables you to generate data into Word documents and e-sign them in Orcanos DMS, or directly sign electronic records.
Integrated Risk Management
Integrate risk into your development, and to your QMS, to assure full traceability, and save 30% of the resources spent on manual management.
Ensures hazards are mitigated and prevents failure from happening Generate Risk Management File in just one-click ISO 14971 ComplianceSchedule Demo
Replace paper-based QMS with Orcanos customizable electronic forms, and achieve higher productivity and efficiency
- 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
What our client say about us
"Very good value for money, very helpful with preparations for audits"
Tsvika - System and Software QA Manager Medical Devices
I mainly used it for RISK management, and for PRD SRS and HRS documents requirements, including traceability to RISK. I also used it for Customer Complaints handling
"Using ORCANOS for Medical Devices"
Gerd E - Lead System Architect
One database, one tool and user interface for requirement-, risk-, test-, CAPA-management etc. Item based!!! with the possibility to generate documents on each level. No need to manage interfaces , relatively fast to configure for own needs, without writing and validation of user-ware. 100% cloud based and platform independent.
"My major tool for conformity."
Stephen - QA Manager
The simple and easy way of controlling documentation. Time saving and ease when undergoing audits by Notified Bodies. Traceability when it comes to CAPA and ECO's.
"I love the flexibility of Orcanos!"
I love the flexibility of Orcanos! It feels like the system is almost 100% configurable, so whenever I think 'it would be nice to do this' then I can always do it within the system. The traceability function is awesome too, it means that we can link our items together so that we can get an overview of the project from top to bottom.
"Orcanos gives use Excellent solution"
Linor V - Document Controller
Flexibility, Fit our needs, Fest answer and
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.
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…
…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…