Orcanos Review

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Orcanos is a requirements management tool that delivers a unified solution with end-to-end traceability, collaboration features, and test management. With one click, an Orcanos user can view actionable data on different phases of product development and quality management system (QMS) processes, with risk management factors integrated. 

Orcanos logo for Crazy Egg Orcanos review.

Orcanos Compared to the Best Requirement Management Tools

Orcanos didn’t make the cut for our list of the best requirement management tools. Most teams looking for a requirements management solution want to integrate it with their existing and Orcanos is just a bit too limited in that regard. Check out our Golden Eggs below as worthy alternatives.

Confluence simplifies collecting requirements and data from multiple sources to create a single source of truth for team members. Try out its Standard or Premium plans on a seven-day trial. offers a straightforward approach to requirements management in a recognizable project management package, with flexible pricing to ensure you’re getting exactly what you pay for. Start your 14-day free trial today.

ClickUp offers versatile features designed to help you manage a broad spectrum of requirements, regardless of the complexity of your processes. Make a deal with ClickUp to get a custom quote.

Orcanos: The Good and the Bad

Orcanos is a flexible and powerful solution that provides easy document exporting, visualization of data and requirements, and dashboards updated in real time. With Orcanos, you can easily track coverage and traceability across different components, ensuring that everything is organized and accounted for. Let’s dive into what makes this software tick.

What Orcanos Is Good At

Orcanos provides you with a single repository for requirements management that comes with several positive features that may position it as a quality solution for your organization. Here’s a rundown of Orcanos’ greatest virtues.

Baseline management: One of the things we like best about Orcanos is its flexibility. It allows you to support your processes exactly the way you want. Customize work items, metadata, access control, and traceability, among other elements. You can also easily track baselines, versions, and changes between versions. 

In addition, Orcanos completely automates version management, showing you in real time every revision and edit from one to another. You can also take snapshots to compare data from different points in time. Other features include impact analysis that can notify you about suspicious changes and the ability to freeze content to prevent any unauthorized changes. 

Visualizations and reporting: Orcanos delivers great ways to view data and information. Tap into real-time updated dashboards that are intuitive to build and easily navigable. Or, use the DocGen feature that lets you import and export word processor files to create requirements documents. Add to this the convenience of Orcanos’ customizable templates and embedded reports, and your team will always be on top of the requirements they need to be aware of. 

End-to-end traceability: You can use Orcanos’ requirements traceability tool to track coverage, including system requirements, hardware and software requirements, test cases, and risk, among other factors. 

What’s more, you can use the Orcanos traceability matrix to integrate research and development with quality management modules like FMEA for risk management, CAPA, and customer complaints. Orcanos also offers a powerful filter mechanism to track missing traceability for key processes, such as requirements without test cases. 

Document collaboration: As part of its requirements management, Orcanos offers a tool for online document creation and editing that can support multiple simultaneous users. Thanks to it, users can access the same document and work together without compromising document integrity or data security. This is a significant advantage for large teams regularly collaborating with external stakeholders, especially when dealing with sensitive documents that may contain items like patient data or trade secrets.

What Orcanos Is Lacking

Orcanos is designed specifically for medical devices, so it can’t necessarily flex for requirements management in other industries. That’s reflected in the following shortcomings, which should tell you whether or not Orcanos can fit the work you’re doing.

Integrations: Orcanos does support integrations with Microsoft 365, Salesforce, Jira Software, Zapier, and a few other platforms. However, this list of available integrations is very restricted compared to other requirements management tools. Considering the whole point of integrating with other software is to make requirements management and testing more convenient, be prepared to put in more time when executing processes through Orcanos. This may also mean the software can’t mesh with other platforms you’re using.

Industry flexibility: Orcanos is a requirement management software specifically designed for medical devices. If you’re a manufacturer of medical devices, you’ll find its quality-related features will fit your requirements perfectly. But, otherwise, the extensive list of medical-focused features and capabilities might be unnecessary or overly complex. Orcanos is likely to be an imperfect fit for other industries, where broader requirements management software can be more effective. 

User experience: Several user reviews pointed out areas for improvement in terms of the user experience on Orcanos. For instance, the system can get slow when all of the registered users start using it at once and the software’s dashboards have a dated feel and design. The admin section is also not very intuitive and requires extensive onboarding. Another user pointed out issues with getting used to the left-hand scrolling dashboard.

Orcanos Options and Pricing

Orcanos is healthcare-minded requirements management that comes in two forms: an application lifecycle management (ALM) platform and a quality management system (QMS). These are priced differently but can also be purchased as a package. 

Orcanos ALM/Design Control 

Landing page for Orcanos lifecycle management with a schedule demo option.

Orcanos’ ALM software is secure, robust, and focuses mainly on helping accelerate your delivery time.

Use its features to plan, approve, trace, and validate industry requirements, as well as manage audits and comply with all applicable regulations. There’s integrated risk management to help you ensure compliance with ISO 14971:2019 and track associated risk, risk without mitigation, and failed test cases.

You also get access to robust test management software for tracking and monitoring test results, including verification and validation processes, generated in document, PDF, or spreadsheet formats. Plus, defect tracking lets you submit, query, update, and report effects while delivering transparent visibility on product features and test cases.

Orcanos doesn’t provide pricing for its ALM plan. You’ll have to schedule a demo for more information and learn the cost. Fortunately, Orcanos provides guided onboarding for free.

Orcanos QMS

Screenshot of Orcanos‘ quality management system with two tests that passed and two tests that failed.

Orcanos‘ quality management system allows medical device companies to ensure their processes are up to date with digital innovation. 

It holds all of the required data points for compliance in a single access point, helping eliminate the need for following a paper trail to understand quality. This also gives you the necessary insights to properly adhere to strict FDA regulations and established ISO quality standards.

The fact that you can monitor reporting elements, including e-DHR, e-DMS, FMEA Risk Management, CAPA, ECO, and Engineering for Verification and Validation in a single system is a huge advantage. 

Other features you’ll find in the Orcanos QMS include:

  • Traceability
  • Electronic forms with e-sign capabilities
  • Dashboards for visually tracking and controlling information
  • Automated workflows for QMS forms
  • AI-assisted real-time compliance monitoring

There’s also a document control software system that allows you to create, trace, search, archive and approve all documentation related to every stage of your medical device product launch. Use the Orcanos Engineering Change Order (ECO) management system to digitally document and control ongoing changes within the product life-cycle.

Orcanos also delivers a complaint management system to alleviate customer concerns and limit the chances of product recalls and damage to your brand’s reputation.

Orcanos doesn’t list any pricing information for its QMS. You can schedule a demo to learn more about what this solution will cost and you can even bundle the ALM and QMS solutions into one Orcanos plan.

Orcanos in Summary

Designed for life sciences companies, Orcanos accelerates the process of developing, producing, and distributing life-saving products and services. It’s a highly collaborative tool with a great feature set that includes a central requirements repository, traceability, and effective management for design, risk, and costs.

However, if you’re looking for more traditional requirements management solutions that can work for industries outside of medtech and pharma, you might want to look at Confluence or Or, dive into our full post, where we examine and list the best requirements management tools.

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