Regulations
Design Control
Quality Management
Orcanos nonconformance software for medical device is a comprehensive solution that enables companies to efficiently manage and track nonconformances throughout the product development process.
Our software is designed specifically to meet the regulatory requirements of the medical device industry and offers a user-friendly interface that streamlines the entire nonconformance management process.
With Orcanos nonconformance module, companies can quickly identify and address nonconformances, track corrective actions, and generate reports for compliance purposes.
Additionally, Orcanos provides real-time visibility into the status of each nonconformance, ensuring that all issues are addressed promptly and effectively.
No More Paper Work
ALM+QMS
Combine Design Control (ALM) with quality management system and regulation in a central repository
Document Generator
Easily generate ready for submission documents from your database
Integrated Risk Management
Integrate risk into your development, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971
21 CFR Part 11 Compliance
Define electronic signature process for a complete documents approval lifecycle
Easy Customization
Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity…), E-sign processes, status flows, mandatory rules and permissions
Dashboards And Analytics
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
End To End Traceability
Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability
Realtime Alerts
Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents. Alerts are automatically fired once a day/week
Your virtual Auditor
Use Orcanos Compliance Engine to get a real-time audit of your projects, anywhere, anytime!
PRICING PLAN
No Hidden Charges! Choose
your Plan.
FREQUENTLY ASK QUESTION
Want to ask something from us?
Yes, we would be happy to demonstrate Orcanos ALM through a web-conference at your convenience. The demo can take 45-60 minutes depending on your needs. To schedule a session, please contact us at [email protected].
We accept payment via credit cards, PayPal, and bank transfer.
For more details, please contact [email protected]
No. You can to select a package based on your needs (Design Control or QMS), where the Premium package includes EVERYTHING.
It means all users belong to the same package
Orcanos ALM is a pay-as-you-go service (monthly or yearly). This means there are no long-term contracts. You can choose to upgrade, downgrade, or cancel your subscription at any time by logging into your Orcanos ALM account or contact us by email at [email protected].
This is a set of validation documents (Requirements Spec, Test Design and Tst results) that you get along with our software, and on each upgrade. They are the proof that the software was validated, and that it is Part 11 Compliant
Your data safe and secured. Orcanos is hosted at AWS and apply the strictest security controls. We have a backup procedure running every 15 minutes. Backup snapshot is encrypted and stored on different servers.
Learn more about the Orcanos Security Center
Yes. If you wish to have users that are read only, it’s possible. Contact us for more details
Yes, you can. To switch plans, please contact us.
Yes, it is. You have a full validation package as part of Orcanos system.
No. One of Orcanos’ advantages, is that you have a virtual environment and YOU get to decide if and when to upgrade your account to a newer versions. This is most critical for regulated companies such as medical device manufacturers.