# Orcanos Reviews 2026. Verified Reviews, Pros & Cons | Capterra > Is Orcanos the right Quality Management solution for you? Explore 37 verified user reviews from people in industries like yours to make a confident choice. Source: https://www.capterra.com/p/92271/ALM-2-0/reviews --- Orcanos 4.3 (37) Provider data verified by our Software Research team, and reviews moderated by our Reviews Verification team. [Learn more](https://www.capterra.com/our-story/) * * * Last updated March 13th, 2026 # Reviews of Orcanos Ease of use 4.3 Customer Service 4.3 ## Pros and Cons in Reviews as adar s VP Clinical and RAMental Health Care, 11 - 50 employeesUsed the software for: More than 2 years. “Some of the features are not user-friendly (i.e. 'protected docs').“ September 11, 2022 DK Dana K QA ManagerMedical Devices, 2 - 10 employeesUsed the software for: Less than 6 months. “It takes time to understand the options and the system, not very intuitive.“ September 6, 2022 ## Showing most helpful reviews Showing 1-25 of 37 Reviews Sort by: Most Helpful Rating Company Size Reviewer's Role Length of Use Frequency of Use Ori G. QA Medical Devices Used the software for: 2+ years ### "Great SW" September 4, 2022 5.0 Pros Test case are easy to handle, upload data, str str Cons Text is small Skipping step by accident and finish others will make the test case to be incomplete Review Source SH Shlomit H. SQA Manager Medical Devices Used the software for: 2+ years ### "Your project needs in one product" September 24, 2019 4.0 Although project setup might take some time and effort, the overall project day-to-day management is easy and saves time. Pros This product is likely to provide your project needs in the best possible way Cons Document Export feature - it needs improvement Alternatives considered [Jira](https://www.capterra.com/p/19319/JIRA/) Reason for choosing Orcanos The ability to handle all project aspects in one product Review Source HH Hadas H. QA manager Pharmaceuticals Used the software for: 2+ years ### "Mainly document control" September 19, 2022 3.0 Pros Easy to use, convenient interface. It is very nice and convenient to be able to upload a document by drag and drop Cons There are many bugs in the system, and the technical service does not always know how to solve the problem. After opening a call in the system, it takes between two and three days for the first response (and the truth is that only \[SENSITIVE CONTENT\] manages to solve my problem) Review Source aS adar S. VP Clinical and RA Mental Health Care Used the software for: 2+ years ### "Review" September 11, 2022 4.0 Overall we are satisfied with the SW Pros Very organized and flow-oriented SW. Easy to doc control and ensure that all the personnel signs the procedure in a timely manner. In addition, it is easy to implement the folders and sub-folders for auditing purposes Cons Some of the features are not user-friendly (i.e. 'protected docs'). We as a company are using a different SW for development and CAPA procedures as the Orcanos solution is too expensive to allow significant number of users, and since CAPA usually requires multi-users, this is not implemented in our company Review Source Tsvika F. System and Software QA Manager Medical Devices Used the software for: 2+ years ### "Very good value for money, very helpful with preparations for audits" January 17, 2019 5.0 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 Pros Web based application is accesible from everywere by those who were defined by role. Everything is orgenized and traceable keeping changes history. It allows to keep implementation and testing coverage updated. The system allows quick and most updated reporting including printable format. Cons Some features like Customer Complaint still requires a desktop application for generating document report. Review Source DA Deniz A. Software Engineer Computer Software Used the software for: 1-2 years ### "Great results" November 30, 2022 5.0 Orcanos is great for companies of all sizes who need a reliable and easy way to manage and control their documents. With Orcanos, you can easily make your documents searchable, create a central online archive, and quickly share and send documents with anyone. Orcanos' web interface is easy to use and lets you manage your documents from any computer or mobile device. You can also create a PDF of any document that you've saved, and email it to your colleagues. Pros I have been using Orcanos for the past year. It is the only tool I use for document management. I use it to manage my work documents, and to keep track of my to do list. It's a great tool to help me get things done. I use it from my phone to review my to do list. It's easy to use and I like that it allows me to organize my documents by people, projects, stages, or products. Cons Thank you for the ease of use it provides, it generally saved me valuable time and worked without any problems. Sometimes it may run slow depending on your internet speed, but here the problem is with the user. Thanks orcanos for a perfect experience. Review Source EF Eleanor F. Laboratory Technician Medical Devices Used the software for: 1-2 years ### "Orcanos: Reliable and Thorough Document Storage" September 6, 2022 5.0 We use Orcanos for our document control and audit compliance; it has been invaluable. Pros Orcanos has excellent accountability regarding document control with the amount of tracked changes it has, along with archiving all other versions for historic needs. Cons The system can be a little slow when there are multiple users on at once, and the file structure can be dauting when first using it. Review Source VR Verified Reviewer CTO Hospital & Health Care Used the software for: 2+ years ### "A great integrated ALM and QMS, perfect for us as a small company" January 10, 2018 5.0 Pros Haldor adopted Orcanos few years back, in order to support our QMS and ALM. I wish to first say that the team at Orcanos has been a great resource and support for haldor, being a part of our team. Together with Orcanos, we recently passed our ISO 13485 audit, presenting comprehensive quality management processes, including document control, and risk matrix integrated to our design controls - everything managed in the Orcanos system! In short, simple tool, yet strong, integrated, so we didnt have to acquire 2 systems, professional and responsive team, and great help in our audits Cons No cons, actually, I would like to see more integrations, but I know Orcanos is now using Zapier, which is great, and maybe more tutorials Review Source SH Stuart H. Quality Manager Pharmaceuticals Used the software for: 6-12 months ### "Would recommend using this QMS" August 22, 2019 5.0 Very good customer service; always easy to get a hold of someone for help; they seemed to take the time to understand our needs during the implementation period and that helped shape the use of the system today. Pros Does everything we need it to do; almost everything within the system is configurable; support is available to help whenever we get stuck; have been through a few customer audits and audits from external bodies since implementing the system and all of the auditors have been very impressed. Cons Getting your head around the admin module is quite daunting at first. It's second nature to me now, but at first it took me a while to work it out. Once it clicks, it's a very easily configurable system and I only get stuck on the odd occasion. Reason for choosing Orcanos Configuration options: most other systems seemed to be quite rigid in that the system would operate in a pre-configured way and we were required to fit our procedures around this, whereas Orcanos allowed us to think 'how do we want to work' and build our system around that. Review Source Tal B. Technical Manager Medical Devices Used the software for: 6-12 months ### "Excellent one stop shop product" January 17, 2019 5.0 Pros The product provides one stop shop for small and medium size medical companies. No need to use another tools in your development process for documentation Cons BOM management is yet not mature enough. Review Source iB irith B. QA Suppervisor Medical Devices Used the software for: Less than 6 months ### "Generally easy to use software with self" November 7, 2016 4.0 I enjoy working with the software is to be understood that the software easy for those who have access to computers. There are lots of problems we need them explanations and understanding everything should be easy to use in any work which is currently not the situation Pros Easy to quickly learn step by step all the steps and translate them on the day Easy to maintain and preserve all documents Cons Lack of knowledge is the main obstacle to the use of the software and follow the development and using it Review Source Response from Orcanos November 7, 2016 Thank you Irith for reviewing ORCANOS e-DMS product and feedbacking us. KH Kobi H. QA Mng Medical Devices Used the software for: Less than 6 months ### "User expirience" January 17, 2019 5.0 Significantly reduces complexity of managing the QMS and enabels e-Sign. In addition , solve design control and risk managment tracability issues. The transition to the system seems smooth and good support from the company Pros Design control tracability and risk managment Cons Interface not intuitive - need some training Review Source PB Peretz B. Used the software for: ### "Peretz from valens" March 28, 2017 4.0 I like this tòol and the option it gives me . The tool provide me abetter control on the testing process and provide a platform for sharing knowladge between departments Review Source YS Yehuda S. Clinical affairs Medical Devices Used the software for: 1-2 years ### "Orcanos standard user" September 7, 2022 4.0 I'm quite use to it by now Pros The option to share document, sign them, track them Cons It is not easy to change your mind in case you need to remove a document Review Source NW Noga W. SQA engineer Medical Devices Used the software for: 2+ years ### "Helpful software " September 7, 2022 4.0 Pros the option to collaborate and simultaneously work as a team on a certain project. Cons The tracing mode is sometimes confusing. Review Source JR Jason R. CTO Medical Devices Used the software for: 6-12 months ### "Medical device QMS with Orcanos" December 6, 2019 4.0 Orcanos QMS provides all of the tools necessary for a Medical Device Quality Management System and a Design Control system. It has helped us significantly in our work towards 13485 & IVDR regulatory compliance. The support team are helpful and knowledgeable and they are always ready to help out with any questions that we have, and are receptive to any suggestions for improvements that we might make. Pros The software is web based and has a very comprehensive level of functionality. It covers requirements management, document control (including electronic signatures), Risk evaluation & management, software test cases and a large amount of pre-built templates. Customisable data dashboards can be created for individual users or groups displaying any data from the internal processes, such as outstanding tasks, digital signature progress, etc. Cons The training module is overly complex, but this is being updated. Reason for choosing Orcanos Cost and level of functionality. Review Source RN Remi N. Software Engineer Health, Wellness and Fitness Used the software for: 6-12 months ### "The typical product tat adds features without removing old ones" September 6, 2022 3.0 Horrible. I use it because my company wants me to. In my next role, if I have a quality system to chose, by default I will not consider Orcanos. Please note this is MY experience of the product and it does not reflect what the company thinks of it. Pros The fact we have one place to check if we have done our trainings or not Cons It is impossible to find its way across the product. Here are the steps to find my trainings: (1) select a project that somehow might have changed (2) select a way to display the items (3) select the right row on the left menu, then find your trainings. This blows my mind each time I use it. And every 2 months I have to re-ask colleagues how to do it. On top of this, the flow is top-right > top-right > mid-left > mid-screen. There is absolutely no UX logic in this. Finally, why can I see what my trainings my colleagues have done? This is absolutely not relevant to me. It just pollutes the useful part of my screen. Review Source HS Hagai S. R&D Lab Managr Medical Devices Used the software for: 1-2 years ### "Orcanos Usage review" September 7, 2022 4.0 Pros 1\. very easy to open and sort folders and files. 2. very easy to track changes. 3. good UI overall Cons Some files are protected and need to "XML " removed from them, which is a bit uncomfortable. Routin sometime have bugs in which not all added single signers are actually added to the signatuers round. Review Source CN CEDRIC N. R&D manager Medical Devices Used the software for: 2+ years ### "A complete and trustful system to manage design files of a medical device" May 8, 2020 5.0 Such a tool is necessary for us to manage traceability from requirements and risks to specifications and verifications. We use it to design our new products and for all upgrades and updates. Pros A deep system of traceability with a lot of practical features Cons This software works differently than other software. Thus it is not easy to present to our colleagues, and it is difficult to make them understand how powerfull it is. Reason for choosing Orcanos Strong system of traceability necessary for the design of medical devices according to the 13485 standard and the 62304 standard. Excellent support. Review Source Response from Orcanos June 24, 2020 Thank you for your comment, we appreciate your feedback. We extensively work on UI/UX so Orcanos would be accessible to all types of users, and any specific feedback will be welcome! Zohar AA Almog A. CEO & VP R&D Biotechnology Used the software for: Less than 6 months ### "Integrated ALM for a growing medical device startup" September 19, 2019 5.0 The main business objective of the Orcanos ALM implementation was to enable us to comply with all regulatory requirements and manage a growing number of documents, data, and traceability while reducing the efforts and the chance of human error. The system now enable us to handle change management and manage the risks involved in a structured manner and be ready for audit on-demand. We liked the fact that multiple projects can share information and be linked together as DMS items can be shared. We havn't yet deployed the eQMS module. Pros the holistic approach that integrates QMS, DMS, Design controls and risk management in one product and the ability to connect documents and processes in a way that enable a relatively small team to manage huge amount of data and keep traceability. Cons Some annoying UI aspects that need improvement and rework (Great support from the Orcanos team though) Reason for choosing Orcanos The holistic approach in combining all the relevant aspects related to Medical Device R&D and the regulatory compliance focus. Good reviews on the web which also indicated very good support/response times. Reference calls to a couple of managers in respected companies using the products' ALM and QMS modules . Review Source HV Habdens V. client Success Manager Computer Software Used the software for: 1-2 years ### "Orcanos" September 7, 2022 4.0 Pros Once you learn Orcanos, it does become easier to use for document management. Cons The training modules can be a little complex Review Source MV Michal V. VP QA Medical Devices Used the software for: 2+ years ### "User experience with the Q-Pack software" November 26, 2019 5.0 Pros The Q-Pack software is very easy to use. Cons Sometime we have some bugs but the Orcanos custoomer support use to resolve it. Review Source AD Aviad D. System engineering manager Medical Devices Used the software for: 1-2 years ### "Orcanos Review" September 6, 2022 3.0 Pros Traceability matrix ,create many filters Cons Slow responses in web page refresh High cost per user account Review Source AK Ariel K. Director System Verification Telecommunications Used the software for: 2+ years ### "User friendly test management app , with quick customization and flexible environment" May 13, 2018 4.0 Pros Flexible Quick Customization for personal needs Fast technical support Support of advanced filters using SQL DB Cons Slowness on the product tree views Not all filters exposed to regular user (some advanced filters supported only for advanced SQL users) Review Source YL Yaron L. VP R&D Hospital & Health Care Used the software for: 6-12 months ### "Traceability is key" January 12, 2017 4.0 We started using QPack quite early in our product development life cycle and in opinion is the best time to start using it. We were up and running very fast. While continuing learning and using more and more features as we go. Pros Very easy to create and maintain traceability between various items (e.g., requirements, risks, tests). Automated generation of documents from database items. Very convenient Document Management System. Cons I'd like to have more flexibility in creating word documents. I'd like to have more tools in batch editing items. Review Source Talk to a Capterra advisor for free and get results within 15 minutes.