ALM and QMS software for
Medical Device

Assure time and cost savings with Orcanos' adaptive platform. Streamline workflows, eliminate redundancies, all within a unified solution.

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All-in-one integrated platform

Are you struggling with a lack of communication flow between your teams?

Integrating ALM and QMS

Orcanos platform integrates ALM and QMS processes for efficient compliance management. This unique approach saves costs, reduces frustration, and shortens the time to market. It benefits both development and quality teams while meeting regulatory standards.

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Document Control

Automate your compliance processes and reduce the bottlenecks on document routing and sign-off. Fire training tasks and use Orcanos Change Control to release new revisions.

Adaptive Compliance

Replace paper-based QMS with Orcanos customizable electronic forms, and achieve higher productivity and efficiency.

Powerful customization tools and simple templates

No coding is required; simply drag and drop

Build custom workflows in just a few clicks

Setup traceability between different artifacts

Supporting a wide variety of field types

Complete access control

Risk Management (ISO 14971)

Incorporating risk management into your development and QMS procedures is essential if you want to attain full traceability and save up to 30% on manual management costs.

What our clients say about us

"A more robust system"

I just wanted to send a quick thank you to the whole team for your patience and for continuing to work diligently with us as we navigate into a more robust system.

Stephen

QA Manager

"My major tool for conformity"

The simple and easy way of controlling documentation. It is time-saving and easy to use when undergoing audits by Notified Bodies. Traceability works great when it comes to CAPA and ECOs.

What makes Orcanos stand out?

ALM and QMS

Integrate Design Control (ALM) with Quality Management System and regulation to establish a centralized repository.

Document Generator

Effortlessly generate submission-ready documents (in Word or Excel) that conform to your company's templates.

Integrated Risk Management

Integrating risk management into the development process and quality events helps prevent potential hazards and failures while following ISO 14971 guidelines.

21 CFR Part 11 Compliance

Orcanos supports electronic records and electronic signatures in compliance with 21 CFR Part 11/Annex 11.

Dashboards And Analytics

Keep track of projects and the status of quality procedures with detailed reports and charts through our customized dashboards.

Easy Customization

Our platform offers powerful customization tools to tailor your quality forms, e-sign processes, status flows, mandatory rules, and permissions to your specific needs and your company's Standard Operating Procedures.

Take your regulatory compliance to the next level with Orcanos. Book a demo today and experience the power of our integrated solutions firsthand!