--- title: Orcanos Reviews meta_title: 'Orcanos Reviews 2026: Details, Pricing, & Features | G2' meta_description: Filter 125 reviews by the users' company size, role or industry to find out how Orcanos works for a business like yours. aggregate_rating: rating_value: 4.3 review_count: 125 scale: '5' date_modified: '2026-07-17' parent_category: name: Life Sciences url: https://www.g2.com/categories/life-sciences --- # Orcanos Reviews **Vendor:** Orcanos **Category:** [Medical Quality Management Systems (QMS)](https://www.g2.com/categories/medical-qms) **Average Rating:** 4.3/5.0 **Total Reviews:** 125 ## About Orcanos Orcanos is a modern MedTech eQMS platform designed to help regulated teams accelerate compliance, stay audit-ready, and streamline quality processes — from design to post-market. Unlike traditional QMS solutions, Orcanos also includes integrated development lifecycle tools (ALM), enabling full traceability across requirements, risks, testing, and quality in one system — without coding. Key Capabilities Document Control & Training CAPA, NCR, Complaints & Audits Risk Management (ISO 14971) Design Control / DHF / DMR Requirements & Test Management End-to-End Traceability Electronic Signatures & Validation Support (FDA, ISO, EU MDR) Why Orcanos Built for regulated hardware, MedTech & pharma Codeless workflows & fast implementation Unified quality + product development data ## Orcanos Pros & Cons **What users like:** - Users commend Orcanos for their **exceptional customer support** , showcasing readiness to assist and resolve issues effectively. (14 reviews) - Users commend the **ease of use** of Orcanos, highlighting its intuitive interface and excellent support for all skill levels. (14 reviews) - Users value Orcanos for its **comprehensive tools** that enhance traceability and streamline product development processes effectively. (8 reviews) - Users value the **high customization** options of Orcanos, allowing seamless adaptation to their unique processes and needs. (7 reviews) - Users appreciate the **user-friendly document management** of Orcanos, benefiting from its intuitive and flexible interface. (6 reviews) - Users find Orcanos **intuitive and easy to use** , appreciating its seamless integration and excellent customer support. (6 reviews) - Implementation Ease (5 reviews) - Users value the **customizability and integration** of Orcanos QMS, enhancing organization and efficiency in quality management processes. (5 reviews) - Automation (4 reviews) - Customization (4 reviews) **What users dislike:** - Users find **feature limitations** in Orcanos, noting gaps in integrations, slow performance, and a lackluster export process. (6 reviews) - Users note that **slow performance** with loading times and server responses hampers their overall Orcanos experience. (6 reviews) - Users find the **learning curve steep** , complicating the use of Orcanos, especially during implementation and revision management. (5 reviews) - Users find the **difficult usability** of Orcanos challenging, particularly with complex administration and limited user support. (4 reviews) - Users find Orcanos to be **not intuitive** , struggling with its complex UI that obscures essential content and files. (4 reviews) - Document Management (3 reviews) - Inefficient Workflow (3 reviews) - Not User-Friendly (3 reviews) - System Limitations (3 reviews) - Difficulty in Modification (2 reviews) ## Orcanos Reviews ### 1. Highly Adjustable and User-Friendly Platform **Rating:** 5.0/5.0 stars **Reviewed by:** Shay N. | COO, Small-Business (50 or fewer emp.) **Reviewed Date:** August 30, 2022 **What do you like best about Orcanos?** I like that Orcanos encapsulates each aspect of company activities and binds them all together. It covers production, QA, RA, procurements, outgoing deliveries, and the use of external subcontractors, giving me a full scope of control. I also appreciate how it simplifies the scrutiny process during audits by EU competent authorities and FDA, making audits successful. Its highly adjustable platform can be configured according to the company's needs. Plus, the initial setup was very easy and user friendly. **What do you dislike about Orcanos?** mainly the issue of data communication. There's a clog in the flow of communication that revokes system agility. **What problems is Orcanos solving and how is that benefiting you?** I use Orcanos for command and control, tracking fabrication and production processes. It encapsulates company activities, providing a full scope of control, and simplifies audits, making them successful. **Official Response from Omri Geva:** > Dear Shay, Thank you so much for your review! We are glad that you and the Estar Medical team are utilizing the benefits of managing both your Design Control and QMS processes in one digital platform. We are looking forward to keeping working with you. Yours, Omri Geva Customer Success Manager ### 2. Excellent traceability and dashboards, but the branching must improve **Rating:** 3.5/5.0 stars **Reviewed by:** Fabien E. | Sociétaire , Mid-Market (51-1000 emp.) **Reviewed Date:** November 15, 2025 **What do you like best about Orcanos?** Traceability between elements is a powerful tool. In auditing, it makes explanations and navigation clear when you want to trace elements from a user need to a subsystem test. The ability to easily create tracking dashboards is also a strength of the software. **What do you dislike about Orcanos?** The branching system is not efficient. A company is constantly working on the future, and ideally, an effective branching and merging system would be very useful. Since the existing solution is not satisfactory for us, we are forced to operate in a more discontinuous manner. **What problems is Orcanos solving and how is that benefiting you?** In addition to the traceability aspect, it allows all technical documentation to be centered on the same tool. The fact that it has a signature system compliant with FDA requirements is a strong advantage. ### 3. Highly Customizable Solution That Adapts to Your Workflow **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** November 04, 2025 **What do you like best about Orcanos?** The main positive point about the Orcanos solution was the customization possibilities to fit the tool to our process and not having to be forced by the tool to implement a certain way of working. Additionally the creation of e-form and approval process are easy to master, making it easier to share knowledge with the entire team. **What do you dislike about Orcanos?** The filter and visualisation tools sometimes doesn't fit the operational needs, conducting us to work with export solutions. The document generation tool has also required our team to come up with an alternative solution to fit our company template and formatting. **What problems is Orcanos solving and how is that benefiting you?** Orcanos is finally a solution that could fit all our needs, from document control to Design & Development documentation. This benefit us by avoiding the multiplication fo the tools in use in the company. ### 4. Customer complaint in Medical Device field management **Rating:** 4.5/5.0 stars **Reviewed by:** Giorgio F. | Regulatory Affairs & Quality Assurance Manager, Mid-Market (51-1000 emp.) **Reviewed Date:** July 02, 2025 **What do you like best about Orcanos?** The Orcanos system was used to transform a process and therefore move to the digital version. The goal is to bring about the digitalization of the customer complaint management system. This is essential to make this process more functional with the utmost attention to the medical sector and therefore to the current regulations (FDA, ISO 13485, etc.). This system manages to combine simplicity and formality. Useful and easy to use for orderly and daily management by all users. Also useful for managing profiles external to the company via log-in password. Excellent customer service for the implementation of requests. **What do you dislike about Orcanos?** It could have a more user friendly user interface perhaps in terms of visualization. **What problems is Orcanos solving and how is that benefiting you?** The Orcanos system was used to transform a process and therefore move to the digital version. The goal is to bring about the digitalization of the customer complaint management system. This is essential to make this process more functional with the utmost attention to the medical sector and therefore to the current regulations (FDA, ISO 13485, etc.). This is essential to comply with the rules of the authorities with the recognized signature system in 11CFR. The system integrates both an internal use for customer complaint management, but also integrates functionality with external users (customers) to share with external users the progress status and results obtained. Graph interface with easy results understanding . ### 5. Outstanding Support and Smooth Onboarding Experience **Rating:** 4.5/5.0 stars **Reviewed by:** Maor K. | Software QA Manager, Small-Business (50 or fewer emp.) **Reviewed Date:** November 16, 2025 **What do you like best about Orcanos?** I've just started using Orcanos a couple of months ago. Unfortunately, I started working in an organisation that has just completed the onboarding process, and although they no longer had "onboarding hours" credit left, Orcanos has suggested to provide me with a couple of sessions to get me up to speed. Also, in the very first "big issue" we had, Orcanos, and Dagan specifically, jumped on the issue and mitigated it in a very professional fashion. **What do you dislike about Orcanos?** I haven't encountered any of these downsides yet. **What problems is Orcanos solving and how is that benefiting you?** I'm still not familiar with all of them, but mainly the entire ALM cycle management for our product, supporting the required documentation and generating everything that is needed for the regulation department. ### 6. Four years with Orcanos - positive experience **Rating:** 4.0/5.0 stars **Reviewed by:** Martin S. | QA/RA Director, Mid-Market (51-1000 emp.) **Reviewed Date:** June 02, 2025 **What do you like best about Orcanos?** I have been using Orcanos for 4 years now and the system has supported well FDA, CE and non-medical device submissions and manufacturing. The current release is fast and accurate. The customer support is very helpful and always wanting to understand our motivation for contacting them. I was not part of implementation of the system but we are planning to add new modules in 2025. Our recent experience with adding the Medical Device File template was smooth. There are a number of useful courses available in the Orcanos Academy, both on general topics as well as specific features of Orcanos. **What do you dislike about Orcanos?** The system is easy to use for end users once set up. but it requires deep understanding on the admin side due to usually more than one option to have the desired result. **What problems is Orcanos solving and how is that benefiting you?** Orcanos is our go-to system for control of electronic documentation and filing third party records. It offers plenty of templates helping to structure D&D projects in the correct way and it is straightforward to write SOPs or Work instruction for relevant processes. Extracting signed documents from Orcanos for regulatory submission is very easy and reliable project documentation trackers have been critical to ensuring that the right files are used. ### 7. QA Director **Rating:** 5.0/5.0 stars **Reviewed by:** Leonid M. | Q, Small-Business (50 or fewer emp.) **Reviewed Date:** January 20, 2022 **What do you like best about Orcanos?** Orcanos e-QMS helps me to organize and manage: 1. Equipment log. Once a week, I get a notification with equipment that will be out of calibration. Therefore equipment undergoes calibration on time. 2. Management Review. Orcanos helped me to build a Management Review presentation by providing charts with predefined criteria. such as: yields, NC's, ECO's, CAPA's. 3. New AI assistance "Ask Paul" provide you external fresh view on MRB or others processes. **What do you dislike about Orcanos?** I am waiting for the mobile version (android and iOS). **What problems is Orcanos solving and how is that benefiting you?** You can manage a QMS out of the office. A must-have tool, especially in these days. MRB risk analysis ### 8. "Orcanos eQMS and Document Control has been exceptionally positive from start to finish." **Rating:** 5.0/5.0 stars **Reviewed by:** Israel H. | QA&RA Director, Mid-Market (51-1000 emp.) **Reviewed Date:** June 03, 2025 **What do you like best about Orcanos?** I have been thoroughly impressed with Orcanos eQMS and Document Control Application. The implementation process was seamless and well-managed, ensuring a smooth transition for our team. The support team has been outstanding—responsive, knowledgeable, and always willing to go the extra mile to assist us. The platform itself is intuitive and user-friendly, making it easy for our team to navigate and maintain compliance with minimal hassle. Overall, it's a robust solution that has significantly improved our document control processes. We’re excited about the possibility of future collaboration and continued improvements. Highly recommended for organizations seeking a reliable and efficient eQMS platform! **What do you dislike about Orcanos?** Waiting for the new revision will improve the flow. **What problems is Orcanos solving and how is that benefiting you?** Significantly improved our document control processes, Compliance to Medical Device regulation and standards. ### 9. Excellent Service Team and Training Experience **Rating:** 4.5/5.0 stars **Reviewed by:** Shiri S. | Administrator, Small-Business (50 or fewer emp.) **Reviewed Date:** November 17, 2025 **What do you like best about Orcanos?** The service team and training are excellent. The AI assistance, along with the Orcanos Academy, has been very helpful in resolving issues independently and efficiently. **What do you dislike about Orcanos?** that i cannot import risks with trackability and have to trace one by one. **What problems is Orcanos solving and how is that benefiting you?** Organize the requirements, risks, and tests in a regulatory framework that enables effective follow-up on product and software development, ensuring alignment with recognized standards as well as consistency and high traceability. **Official Response from Rami Azulay:** > Thank you so much. We have made a 180-degree change to our SLA and are pleased to see the results. At your service, ALWAYS! ### 10. Fast start with Orcanos **Rating:** 4.5/5.0 stars **Reviewed by:** Leslie . | Sr. Manager, Clinical Affairs, Small-Business (50 or fewer emp.) **Reviewed Date:** November 10, 2025 **What do you like best about Orcanos?** Orcanos implementation was very easy and quick. Their customer support is wonderful and I appreciate their responsiveness. **What do you dislike about Orcanos?** As we are using the system in a non-traditional way, there are a few features that are not built in and would be nice to have. The Orcanos team has been very flexible to help us solve these issues. **What problems is Orcanos solving and how is that benefiting you?** Part 11 document storage is our main concern. This is an easy solution for document archiving. ### 11. All in one organizational solution to all related to QMS management **Rating:** 4.5/5.0 stars **Reviewed by:** Omer S. | Global Quality Director, Enterprise (> 1000 emp.) **Reviewed Date:** September 10, 2025 **What do you like best about Orcanos?** Relatively simply and straightforward for the end users, similar look-n-feel all across the different modules, all-in-one solution **What do you dislike about Orcanos?** Hierarchies structure and search tools to do clear and modular. UI tends to |hide" the actual object people mostly look for - the file itself - need to focus more on the content/file in the UI **What problems is Orcanos solving and how is that benefiting you?** one solution, mostly for document control but not only ### 12. Intuitive Workflows Make Operations Effortless **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** November 17, 2025 **What do you like best about Orcanos?** “The system is easy to operate, featuring intuitive workflows that facilitate both training and routine use. It offers straightforward implementation, seamless integration into current processes, and reliable, responsive customer support.” **What do you dislike about Orcanos?** The way documents are arranged before and after downloads is cumbersome and not well managed. **What problems is Orcanos solving and how is that benefiting you?** There is now well-established traceability between the URS, SRS, product requirements, and tests, addressing the poor management that existed previously. ### 13. I have been working with Orcanos for the past 4 years for both MD and NMD programs **Rating:** 4.5/5.0 stars **Reviewed by:** Oz G. | Verification and Validation Manager, Mid-Market (51-1000 emp.) **Reviewed Date:** March 13, 2025 **What do you like best about Orcanos?** Orcanos is a very ease of use application and support both MD and NMD workflows. Orcanos provide you ability to manage URS, SRS, DSRS, Risks, verification procedures and results with full automation support (Rest API), traceability, SPRs (defect management, DRB and IAB), etc.. Almost everything can be customized in Orcanos tool and what is not available - can be quickly developed and implemented with their professional services and support. They are great and very responsive. We also establish a bridge between our Orcanos and Rally system. **What do you dislike about Orcanos?** Orcanos suffers from instability issues over time. Their supports works great to resolved the issues ASAP, but they need to improve their reliability and documentation performance. **What problems is Orcanos solving and how is that benefiting you?** We implement the entire workflows of GEHC into the tool, so defects - SPRs can be also pass the DRB and IAB processes via Orcanos tool. the release documentation is also part of Orcanos tool and almost the entire verification documentations are also part of Orcanos tool that resolved almost all our formal docs issues. This allow us to accelerate the entire documentations from weeks to days. ### 14. Orcanos usage evaluation **Rating:** 5.0/5.0 stars **Reviewed by:** Chien N. | Principal Design Quality Engineer, Small-Business (50 or fewer emp.) **Reviewed Date:** September 22, 2025 **What do you like best about Orcanos?** Easy to use and navigation. The structure of Orcanos is clean and customer support is great. **What do you dislike about Orcanos?** Searching in Orcanos is sometime a bit slow and may not get into specific item **What problems is Orcanos solving and how is that benefiting you?** Good system to use for review, approval and housing QMS SOPs, product development process and product manufacturing and quality control processes. ### 15. Improvement of quality processes and management of documentation **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Health, Wellness and Fitness | Small-Business (50 or fewer emp.) **Reviewed Date:** January 21, 2026 **What do you like best about Orcanos?** Facilitate the management of quality documentation and ensure the traceability of documents **What do you dislike about Orcanos?** Management of external documents in Excel format **What problems is Orcanos solving and how is that benefiting you?** the management of quality documentation is better than before ### 16. Orcanos is a powerful and versatile software suite **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Transportation/Trucking/Railroad | Small-Business (50 or fewer emp.) **Reviewed Date:** May 18, 2022 **What do you like best about Orcanos?** Orcanos provides tools for everything from document control and requirements management to test planning and risk assessments. This can significantly streamline operations and improve traceability. Additionally, the ability to customize the environment is a great feature to align everything with a company's needs. **What do you dislike about Orcanos?** Setting up the system to match your company’s specific workflows and data requirements takes time and thoughtful planning. If you jump in too quickly, it may be difficult to change things without requiring re-work. It's important to take the time to make sure the field layouts for work items and other aspects are going to work long term. **What problems is Orcanos solving and how is that benefiting you?** Orcanos has provided a solid document management environment for our company. ### 17. Exceptionally User-Friendly and Efficient Document Management **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** December 03, 2025 **What do you like best about Orcanos?** This software is very user-friendly and handles document management efficiently. **What do you dislike about Orcanos?** I don't have many dislikes about the application; overall, everything is quite good. **What problems is Orcanos solving and how is that benefiting you?** Exceptionally User-Friendly and Efficient Document Management **Official Response from Rami Azulay:** > Thank you so much for your fantastic, genuine review. Many will learn from it and hopefully take the same step as you did. ### 18. Powerful eQMS with great support staff **Rating:** 5.0/5.0 stars **Reviewed by:** Patrick L. | Chief Operating Officer, Small-Business (50 or fewer emp.) **Reviewed Date:** May 15, 2025 **What do you like best about Orcanos?** Intuitive to use, and tech support is ready and willing to help. Orcanos can also provide contract QA services, or connect you with local contracting support **What do you dislike about Orcanos?** Time zone can be challenging with very early calls for Israeli time. Also, because there isn't yet a big user base in the US, its challenging to find QA professionals with Orcanos experience. I hope that changes, as it is a great package. **What problems is Orcanos solving and how is that benefiting you?** We use Orcanos as our QMS. So far it handles our design control matrix ### 19. Effortless Setup, Excellent AI Support, and Robust Traceability **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** November 17, 2025 **What do you like best about Orcanos?** This is a straightforward software to use, making it accessible even for those who are not very tech-savvy. Additionally, the AI support provided is excellent and truly enhances the overall experience. **What do you dislike about Orcanos?** I have trouble understanding how the revision management functions. Additionally, I have encountered some server issues. **What problems is Orcanos solving and how is that benefiting you?** Our company relies on Orcanos to organize and manage our software project test cases. ### 20. Orcanos streamlined our QMS with audit ready report generation and enhanced traceability - AB **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Research | Small-Business (50 or fewer emp.) **Reviewed Date:** September 12, 2025 **What do you like best about Orcanos?** features like audit ready report generation, customizable fields, traceability throughout the entire product development process and it's documentation **What do you dislike about Orcanos?** No major issues- but could improve upon certain complex workflows like reports automatically incorporating results from multiple test runs. **What problems is Orcanos solving and how is that benefiting you?** audit ready report generation and ensuring traceability along with its documentation through entire product development process. ### 21. Working as SQA and using Orcanos as our main platform **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** April 02, 2025 **What do you like best about Orcanos?** Endless options which makes it one platform for all SQA's needs **What do you dislike about Orcanos?** Not intuitive and really webby. i would like it to be more easy to use. **What problems is Orcanos solving and how is that benefiting you?** One platform tha t consilidate all RND needs. From SR to Running the tests ### 22. Professional, Humen and caring **Rating:** 5.0/5.0 stars **Reviewed by:** Iko B. | Chief Service & Support, Small-Business (50 or fewer emp.) **Reviewed Date:** November 15, 2023 **What do you like best about Orcanos?** The best of Orcanos is their team (from customer support to mangment) , they are profssionals, freindly ,accurate and aleays give a quick response. Orcanos have everything needed from QMS to full ALM. As a Medical Device Engineering expert I frequantly use Orcanos for regulatory , design control , project control etc. from finance to regulator audits. In general the usage is easy and so was the implmention and integration. **What do you dislike about Orcanos?** There are view dislikes , somethims the loading time is a bit on the slow side. **What problems is Orcanos solving and how is that benefiting you?** To begin with our QMS needs as ISO13485 Medical Device - the audits , document control, reports etc. moving from paper based QMS to eQMS was extrimlly benfical. Using the ALM suite , helps in project control from it design, reviwes and also in finance - Basically we are running our project via Orcanos. ### 23. Easy to use ALM tool **Rating:** 4.0/5.0 stars **Reviewed by:** Rupa S. | Quality Lead, Mid-Market (51-1000 emp.) **Reviewed Date:** February 29, 2024 **What do you like best about Orcanos?** Love the team. They are always available. Its a good tool with a number of features. Excellent for risk and document management. **What do you dislike about Orcanos?** It does not have integrations with popular automation test frameworks.Also the tool often becomes slow. **What problems is Orcanos solving and how is that benefiting you?** It helps us in our QMS processes. Also we are using it for requirement and test management which has made generation of traceability very easy ### 24. Easy to use ! **Rating:** 4.0/5.0 stars **Reviewed by:** Cedric Q. | Mid-Market (51-1000 emp.) **Reviewed Date:** February 14, 2024 **What do you like best about Orcanos?** - it is very configurable, traceability is clear - the API allow to automatize a lot of actions **What do you dislike about Orcanos?** - the branching not very well managed. It is rarely the case though with ALM tools I find. Hard to satisfy every use cases . No clean merging capability. **What problems is Orcanos solving and how is that benefiting you?** Traceability between requirements and test cases Risk management Document control ### 25. Effective to an extent but cumbersome with UX Issues **Rating:** 3.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** October 19, 2023 **What do you like best about Orcanos?** As a frequent user of the platform, processing over 400+ documents a year with release and update, using the system daily. Orcanos is great for quality document control and supporting changes and release of work. It has a great mechanisim for keeping track of items and ensuring up to date release using DMS items and ECO features. This is where it shines and it most effective. Customer support, is responsive and sufficent for addressing any issues. But these issues could also be avoided. **What do you dislike about Orcanos?** The general UX interface of the platform is very complex with a lot of unecesarry clicks and fields which could be simplified. While all these processes have purpose and are effective it could be simplified and more adapable. This greaty diminished the ease of use. There is also a issue with lag and crashing on occasion which can be frustrating. When it comes to doing bulk work, controling and updating 400+ documents presents and makes the platforms draw backs very clear. It does not make doing bulk release very simple and has a lot of back and forth or external windows or task panes to achieve the final outcome. **What problems is Orcanos solving and how is that benefiting you?** As a UX design engineer Orcanos main role, day to day, is to support clear revision control and release of documentation. This could be technical drawings, user guides, opperationg procedures etc. This includes effective quality control and release to stake holders, along with implimentation of training and review. Orcanos provides a method for clear revision control and also a release process which is the main benifit. ### 26. Orcanos is a very prestigous platform **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** July 02, 2024 **What do you like best about Orcanos?** I like how amazing the customer support team is **What do you dislike about Orcanos?** The platform is very very slowsometimes. **What problems is Orcanos solving and how is that benefiting you?** I had problems with a pdf upload and they worked together to ensure the pdf got uploaded correclty from their end. This helped me continue with my uploading process of future versions. ### 27. A must-have system for any medical device company **Rating:** 5.0/5.0 stars **Reviewed by:** Avishay S. | Small-Business (50 or fewer emp.) **Reviewed Date:** January 31, 2024 **What do you like best about Orcanos?** Far superior to manual handling of the development cycle **What do you dislike about Orcanos?** Export to docx requires further formatting (at least when attempted, quite a while back) **What problems is Orcanos solving and how is that benefiting you?** - Making changes in requirmenets without breaking traceability - Maintaining organizational memory with respect to product development ### 28. A one stop solution for eqms, documnet control and part managment **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** December 01, 2020 **What do you like best about Orcanos?** The system allows in one package to manage eqms and all doc control and has an easy and very simple parts managment including ECO and lifecycle. the 3 seperate parts have full tracability between them so its very easy to handle the full process from end to end. we connected the system to our tester and to customer support so we a fully connected system. **What do you dislike about Orcanos?** need to learn the system, not automatically intuitive, but once you get over the initial step it works nicely. **Recommendations to others considering Orcanos:** i'm learning all the attributes of this SW but until now it looks an excellent choice, giving full support for our needs and even more. Orcanos have a great team and they are easy to work with. **What problems is Orcanos solving and how is that benefiting you?** all qaulity managment document control document traceability traceability of information from MRD to SRS to testing to issues in the field and solutions Parts managment ### 29. 1 year of experience in DMS mostly and CAPA Management **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** February 08, 2024 **What do you like best about Orcanos?** The upsides of Orcanos are: 1. The user experience of DMS module. 2. Having all QMS modules in the same system under one license. **What do you dislike about Orcanos?** The downsize of Orcanos - No online edinting option. **What problems is Orcanos solving and how is that benefiting you?** Document control Managment of product chages in one place. Follow up on action items Knowlagde sharing ### 30. Implementing Orcanos at another Medical Device Start Up **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** April 24, 2023 **What do you like best about Orcanos?** On careful consideration, I selected Orcanos for the second time. Four years ago, I implemented Orcanos at Third Pole Therapeutics. They are still using Orcanos and clearly quite happy. In the interim, I implemented Arena as central eQMS for a consortium of start ups. At New View Surgical, we need a full solution; ALM, eQMS, pre and post market. My engineers wanted an intuitive interface, making it look similar to their current work. Orcanos is the only one that can do it all. **What do you dislike about Orcanos?** Any system has downsides; Orcanos is a lot when you are doing feasibility. But when you know you need a comprehensive solution. The flexibility comes at a cost of learning curve. **What problems is Orcanos solving and how is that benefiting you?** We need to rapidly implement a full eQMS including post market activities, complaint handling, etc. Yet at the same time, bring our DHF to exemplary levels. I know that using Orcanos, I can keep my headcount down. We need an eQMS as powerful as Arena, ALM to approach JAMA, yet integrate Defect Management across them both, while keeping price point at a fraction of those combined. ### 31. Easy to administrate **Rating:** 4.0/5.0 stars **Reviewed by:** Sylvain B. | Small-Business (50 or fewer emp.) **Reviewed Date:** February 22, 2023 **What do you like best about Orcanos?** As software administrator, I like how it is possible to customize the configuration, especially the community organization. A solution can contain multiple projects. A project can have multiple groups depending on the work people must do inside the project. A group can contain multiple users. A user can belong to different groups with different permissions and depending on the project, the correct group for the user can be selected to provide the access needed to do the requested work. The granularity provides us enough flexibility to secure as much as possible access and data. It is easy to configure and maintain. SB **What do you dislike about Orcanos?** Sometimes, in the software administration, when we navigate to the different tabs, we do not see what we are editing initially. **What problems is Orcanos solving and how is that benefiting you?** We are managing requirements, risk management, test management inside different projects for the different releases of our product. ### 32. Good, manage documents and design control **Rating:** 3.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** January 31, 2024 **What do you like best about Orcanos?** Charts in orcanos, and to sign routing on documents. **What do you dislike about Orcanos?** Very slowly, still have some bug when you try to start a routing **What problems is Orcanos solving and how is that benefiting you?** Make an order in document control ### 33. QA Manager **Rating:** 3.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** April 03, 2023 **What do you like best about Orcanos?** A handy and robust platform for the whole "Document/Records Control" field (QMS). **What do you dislike about Orcanos?** As a QA Manager and a Lead Auditor (Medical Device ISO13485 & 21CFR-820)- this platform may show "over information", which may cause misleading/ misunderstanding. For example, I don't want the auditor to see all the iterations made to the same document whose revision came up - I don't need him to see that all kinds of corrections were made behind the scenes with no actual meaning. **What problems is Orcanos solving and how is that benefiting you?** As I described earlier, the Orcanos platform gives me a direct response to comply the 4.2. chapter in the ISO13485- "Documentation requirements". Hence, I can manage the documents in one place and link one to another. I can comply with the "Document Control" requirement specified in section 4.2.5. ### 34. Customizable and relatively intuitive solution for ALM, improvements are still required **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** September 07, 2022 **What do you like best about Orcanos?** The system structure is clear and easy to use most of the time. Customization allows adjustement to the user specific needs and worflow. Customer service is responsive and replies quickly. **What do you dislike about Orcanos?** The system contains bugs and sometimes certain flows or actions cannot be adjusted to our exact need, solutions for these issues require further development and are not always available. **What problems is Orcanos solving and how is that benefiting you?** Orcanos system provides a simple solution for handling product requirements, tests, defects and risks management, including traceability and versions. The wide customization allows us to adjust the system to our need and create our own workflows. ### 35. First Experience with Orcanos **Rating:** 4.5/5.0 stars **Reviewed by:** Yuval S. | Founder, Small-Business (50 or fewer emp.) **Reviewed Date:** August 23, 2022 **What do you like best about Orcanos?** I have several subjects i liked best with Orcanos: 1. it's ease of use 2. It's intuitive and freindly interface 3. It's flexibility 4. It's ability to create documents, requirements and risks into the system without the need to create an additional document **What do you dislike about Orcanos?** I think that the following could be improvements: a. Signature routing process depended on the hierarchy (meaning - employee managers are directly the signees) b. The ability to create automatic document ID based on document specific catalog **What problems is Orcanos solving and how is that benefiting you?** Orcanos solves the problem of archiving and traceability. ### 36. Overall Functional System that Needs Improvement **Rating:** 4.0/5.0 stars **Reviewed by:** Dan Y. | Director, Clinical Command Center, Mid-Market (51-1000 emp.) **Reviewed Date:** May 20, 2022 **What do you like best about Orcanos?** The thing I like best is that it is easy to route documents and other attachments through various people to sign off or approve/disapprove. The website also keeps records of version changes and when things were approved. As an audit tool, it works well. **What do you dislike about Orcanos?** The website/system is NOT very intuitive or user-friendly. There is a slight learning curve, and even then it is not a great interface for the end-users. It is also not easy to search for documents or information in my opinion. **What problems is Orcanos solving and how is that benefiting you?** This system works well for us to complete compliance audits and track documents that are inspected during different types of audits from different organizatons. ### 37. Orcanos system for medical device field **Rating:** 4.0/5.0 stars **Reviewed by:** Lotan H. | Small-Business (50 or fewer emp.) **Reviewed Date:** February 06, 2023 **What do you like best about Orcanos?** Orcanos provides all the main processes for medical device development on the same platform. Each function can be customized for the company's needs, making it very comfortable to use. After implementing the new version, unlimited custom fields are available, which improves the user experience. Customer service is usually available and very helpful. **What do you dislike about Orcanos?** Sometimes the system is slow and needs to be refreshed. Finding what you need in the admin section is not always intuitive. **What problems is Orcanos solving and how is that benefiting you?** QMS, DMS, Non-Conformance, Complaints, Electronic signatures ### 38. managing quality system in small company is efficient, easy and paperless **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Health, Wellness and Fitness | Small-Business (50 or fewer emp.) **Reviewed Date:** January 24, 2022 **What do you like best about Orcanos?** ORcanos is intuitive and paperless. Easy to use **What do you dislike about Orcanos?** I have no negative input. I appreciate the program **Recommendations to others considering Orcanos:** Go for it! **What problems is Orcanos solving and how is that benefiting you?** Time-saving to obtain signatures Time-saving in filing traceability Tracking action items paperless ### 39. Great user interface update **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** March 30, 2023 **What do you like best about Orcanos?** It is easy to find the most up-to-date documents I need for my work. Also, the document approval process is easy to track. It is much more convenient than other systems I've used in the past. **What do you dislike about Orcanos?** In the previous version, I had a hard time finding the documents I was after. But the system has recently been updated, and that problem has been completely resolved. **What problems is Orcanos solving and how is that benefiting you?** Document management, version history, document retrieval, and document approval processes. It definitely helps me be more effective at work, and increases my business performance. ### 40. Good experience , intutive, user friendly and very organized **Rating:** 4.0/5.0 stars **Reviewed by:** Hagai S. | Mid-Market (51-1000 emp.) **Reviewed Date:** March 23, 2023 **What do you like best about Orcanos?** Excellent revision management. Excellent UI/UX easy to learn. **What do you dislike about Orcanos?** Sometimes signing peers is very slow. Creating a signing group is restricted only to admins. Uncontrolled downloads sometimes take a long time to be downloaded. **What problems is Orcanos solving and how is that benefiting you?** Revision review and trace. Traceability matrix. Validation and verification that we can write directly to Orcanos. Managing ECOs is easier. ### 41. Very friendly and easy interface **Rating:** 4.0/5.0 stars **Reviewed by:** Alex R. | Small-Business (50 or fewer emp.) **Reviewed Date:** March 23, 2023 **What do you like best about Orcanos?** Very friendly and easy interface Highly recommended software for efficient document organization - Very fast and efficient technical support service. **What do you dislike about Orcanos?** As with any interface, there are sometimes problems and bugs - the technical service quickly responds to any issues. **What problems is Orcanos solving and how is that benefiting you?** Orcanos helps build an orderly product tree and organizes all the documents ### 42. Orcanos system **Rating:** 3.5/5.0 stars **Reviewed by:** Dorothea M. | QA/RA Manager, Small-Business (50 or fewer emp.) **Reviewed Date:** February 18, 2022 **What do you like best about Orcanos?** The system is adaptable and can be customized to the company's needs. Orcanos has multiple modules that can be implemented gradually based on company status and they can be adjusted based on the pace of onboarding of each company. **What do you dislike about Orcanos?** It is not a plug-and-play system and requires time and resources. The system is outdated when it comes to requirements (still follows MDD in EU!!) The admin part of Orcanos is a nightmare. **Recommendations to others considering Orcanos:** 3 days of onboarding of Orcanos is simply not enough. The admin part is a huge part of Orcanos. Moreover, all the e-forms are still using MDD (outdated since May 2021) thus a lot of corrections need to be made in the company. My QMS auditors would expect to see Orcanos as a critical supplier but since Orcanos doesn't have ISO 13485 certification, it makes things very difficult for a medical device company. Moreover, one should expect spending many hours trying to figure out issues with the Chat functionality or ticket raising - it is not always that they understand the issue or how to solve it. **What problems is Orcanos solving and how is that benefiting you?** Electronic signing, creating traceability between items, keeping electronic forms, more accessible training of employees. ### 43. Orcanos Usability **Rating:** 4.5/5.0 stars **Reviewed by:** Habdens V. | Customer Success Manager, Mid-Market (51-1000 emp.) **Reviewed Date:** April 18, 2023 **What do you like best about Orcanos?** I like the fact that it does have a copy of version changes and documents can be assigned to individuals. **What do you dislike about Orcanos?** I think it can be difficult to navigate through modules. **What problems is Orcanos solving and how is that benefiting you?** Document tracking and compliance audits ### 44. M.C. **Rating:** 4.5/5.0 stars **Reviewed by:** Moni C. | V.P. R&D, Small-Business (50 or fewer emp.) **Reviewed Date:** September 01, 2022 **What do you like best about Orcanos?** Ease of use for: Traceability Tables Advanced User-Defined Filters DashBoards User-Defined Process Flows Excellent technical support and step up to the system **What do you dislike about Orcanos?** I would like to have more colorful screens The Export process is a little bit poor... **What problems is Orcanos solving and how is that benefiting you?** 1. Traceability. 2. Fine Tune to the Requirements and the testing 3. Full DHF control ### 45. Makes more sense to big companies, not sure how beneficial to startups **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** February 21, 2022 **What do you like best about Orcanos?** the organization in records which are easy to maintain. The ability to maintain in parallel several products **What do you dislike about Orcanos?** slow server but better than before GUI is not very user friendly No keyboard shortcuts Editing requirements should be "word like" experience **What problems is Orcanos solving and how is that benefiting you?** Software Requirements (SRS) Testing (STD, STR) ### 46. Orcanos: Document Control Extraordinaire **Rating:** 5.0/5.0 stars **Reviewed by:** Eleanor F. | Laboratory Technician/Equipment Officer, Mid-Market (51-1000 emp.) **Reviewed Date:** October 19, 2022 **What do you like best about Orcanos?** The clarity of change logging and the secure document storage allows for record management with absolute confidence. I've no shadow of a doubt that we wouldn't have done anywhere near as well in our last audit without Orcanos. **What do you dislike about Orcanos?** The system can be a little slow when all of the registered license users are on it at the same time, and the routing process can cause a lot of emails to build up in the inbox, but otherwise it's great. **What problems is Orcanos solving and how is that benefiting you?** We use Orcanos for our quality management system, with a focus (for me at least) on calibration records for our production equipment. It is an invaluable repository for such critical documents. **Official Response from Omri Geva:** > Hi Eleanor, Thank you for your review! We are glad that you are gaining value from Orcanos and that we have helped you succeed in your last audit. On our latest version - Orcanos 5.2, we have improved the application’s performance on several levels making it faster and smoother. We are looking forward to keeping working with you. Yours, Omri Geva Customer Success Manager ### 47. Good potential, limitations in reuse ALM in multiple projects, **Rating:** 3.0/5.0 stars **Reviewed by:** Assaf R. | Small-Business (50 or fewer emp.) **Reviewed Date:** February 19, 2023 **What do you like best about Orcanos?** Orcanos can be customized with specific fields for filtering/sorting **What do you dislike about Orcanos?** very complex to reuse items in ALM. no support for references in ALM hard/long phase-in **What problems is Orcanos solving and how is that benefiting you?** ALM for risk mgmt and requirements mgmt and traceability to test protocols Doc mgmt for QMS documents ### 48. Does the job well **Rating:** 2.5/5.0 stars **Reviewed by:** Jacob N. | Research Intern, Mid-Market (51-1000 emp.) **Reviewed Date:** October 21, 2022 **What do you like best about Orcanos?** Organization, it is pretty easy to find all the files I need and easy to navigate. The layout isn't overwhelming and it took me a very short time to become comfortable with the interface. **What do you dislike about Orcanos?** Nothing specifically comes to mind, the interface is easy to understand, the dashboard could use some improvement. I don't love the left-hand side scrolling dashboard, it makes it difficult to find things. **What problems is Orcanos solving and how is that benefiting you?** Keeping all files in an organized easy to find repository. Looking up files, both current and old versions is easy now. Orcanos has definitely helped me become more productive. **Official Response from Omri Geva:** > Dear Jacob, Everyone at Orcanos appreciates it when a customer takes the extra time to post a review. Thank you! I am glad you are gaining value from our Document Control module and that it is helping you be more productive. Following up with your review score, I'd appreciate the opportunity to understand where you think we can improve so you could get the best value out of Orcanos. You are welcome to personally connect with me at omri.geva@orcanos.com and share your feedback. Yours, Omri Geva Customer Success Manager ### 49. Orcanos - True all-in-one eQMS/ALM/MES platform for med device development and manufacturing **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** October 21, 2022 **What do you like best about Orcanos?** Orcanos has truly integrated all of the key relational database elements needed for medical device development, from a fully-fledged eQMS, to ALM for requirements management and testing and MES. Seeing all these key functionality existing in a single relational database platform is impressive. Orcanos has also captured key functionality from PLM style systems, such as eBOM, supplier management, etc., to round out the tool. **What do you dislike about Orcanos?** There is a learning curve for Orcanos to understand the environment and configure and customize workflows - even if being savvy on other platforms. But once you get to the "aha(!)" point of learning the system, it quickly becomes intuitive. To overcome any learning curve barriers, Orcanos has provided great on-boarding support through their Customer Success group in additional to online video support through Orcanos Academy. **What problems is Orcanos solving and how is that benefiting you?** Abram Scientific **Official Response from Omri Geva:** > Dear customer, Thank you for your review! We are glad for the opportunity to help you optimize your QMS and ALM processes, so you can excel in developing your outstanding medical device. We are looking forward to keeping growing with you. Best, Omri Geva Customer Success Manager ### 50. For a Mid Size Business, Orcanos is just right. **Rating:** 4.5/5.0 stars **Reviewed by:** Jeremy K. | Director of Systems Engineering, Small-Business (50 or fewer emp.) **Reviewed Date:** October 20, 2022 **What do you like best about Orcanos?** Flexibility and Customization. We do User Needs, System Requirements, Subsystem Requirements, API export and linkage to outside tools, document importing, and much more, all with the ability to customize lists, tags, categories, parent structure etc. **What do you dislike about Orcanos?** Sometimes it is not intuitive where to find what you're looking for in the Admin menus. Then we use the online FAQs and Orcanos Tech Help. **What problems is Orcanos solving and how is that benefiting you?** Traceability and Organization of Requirements is our primary problem solved by Orcanos. The relational database with customizable search, tables, and export really helps with communication and alignment across functions. **Official Response from Omri Geva:** > Dear Jeremy, Thank you for your review! We in Orcanos are committed to our partnership with Cellares and thirled with your success. Orcanos’ flexibility and customization capabilities are a part of our DNA. We understand the importance of allowing you to adjust your account to your work processes and integrate with other platforms you are working with so you meet your business goals. I look forward to meeting you soon and hearing about your growth and new challenges. Best, Omri Geva Customer Success Manager ## Orcanos Discussions - [Does an Orcanos user community forum exist and is it possible to share experiences](https://www.g2.com/discussions/does-an-orcanos-user-community-forum-exist-and-is-it-possible-to-share-experiences) - 1 comment, 1 upvote - [View Orcanos pricing details and edition comparison](https://www.g2.com/products/orcanos/reviews?qs=pros-and-cons§ion=pricing&secure%5Bexpires_at%5D=2026-08-02+03%3A47%3A26+-0500&secure%5Bsession_id%5D=5eef1b42-c6cf-4baf-b455-9d6ec6dce5f1&secure%5Btoken%5D=5fc171e5b0cf03b4210b92dceb305c1521f36775ac97197cc4552076aca19c41&format=llm_user) ## Orcanos Integrations - [Oracle Product Lifecycle Management (PLM)](https://www.g2.com/products/oracle-product-lifecycle-management-plm/reviews) ## Orcanos Features **Quality Management** - Design Controls - Audit Management - Supplier Network Management - Risk Management **Nonconformance** - Conformance Records - CAPA - Change Management **Quality System** - Analytics & Reporting - Real-time Collaboration - Document Control - Quality Processes **Quality system** - Document Control - Collaboration - Analytics and Reports **Risk Management** - Assessments - Operational Risk - Supplier Evaluation **Inspection Management** - Templates - Workflows - Corrective Actions **Compliance** - Standards & Regulations - Certifications **Platform** - Integration - Security & Privacy - Mobile Access - Flexibility **Services** - Implementation - Training & Learning - Customer Support - Professional Services ## Top Orcanos Alternatives - [Qualio](https://www.g2.com/products/qualio/reviews) - 4.4/5.0 (772 reviews) - [Greenlight Guru Quality Management System](https://www.g2.com/products/greenlight-guru-quality-management-system/reviews) - 4.5/5.0 (401 reviews) - [Arena PLM & QMS](https://www.g2.com/products/arena-plm-qms/reviews) - 4.2/5.0 (452 reviews)