Orcanos ALM Software System


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Our Reviews on G2...

Orcanos is a leader in Medical QMS on G2 Orcanos is a leader in ALM Software Suites on G2 Users love Orcanos on G2 Orcanos is a leader in ALM Software Suites on G2

ALM Software System

Manage all your ALM related items from documents such as MRD, Phase SRS, Feature / Functional SRS, ATP / ATS in one database. Advantages are many such as:

  • Full Traceability and Coverage matrix
  • Manage related tasks, defects, meetings, codes, test execution results
  • Easily manage versions
  • Immediate view of direct impact of any requirement or defect
  • Plan, analyze and estimate effort
  • Never have outdated documents and orphaned features
  • Create a fresh set of updated document suite with a click of a button
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Requirements Management

Orcanos ALM Requirements Management tool allows you to plan, approve, trace and validate requirements, manage any audit, compliance or regulatory and integrate to your office environment.

Test Management

Orcanos Testing-Suite for test management provides all you need for your verification and validation processes. Operates over Orcanos ALM central repository, Orcanos Test Management Tool allows efficient test management, tracking, and monitoring of test results, and generate your documents, such as Test Design and Test Results into Word, PDF, Excel and more.

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Defect Tracking

Orcanos Defect Tracking system allows all project participants to easily submit, query, update, and report defects, where every single defect can be reported under specific requirements – guaranteeing better traceability.

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!"

Stuart H

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


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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Design Control (ALM), Quality Management, Or The Full Orcanos Suite


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 documetns  (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.