Very good value for money, very helpful with preparations for audits
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
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.
Some features like Customer Complaint still requires a desktop application for generating document report.
Your project needs in one product
Orcanos provided a good solution for doc controls on few companies I am working with. There are still place for imrpovemrnts that will make easier QA engineers and managers life
Easy to use for instored "modules". Can issue reports. Signature process easy.
Still need some adaptations. To cover all qms needs.
A great integrated ALM and QMS, perfect for us as a small company
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
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
Would recommend using this QMS
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.
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.
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.
Medical device QMS with Orcanos
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.
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.
The training module is overly complex, but this is being updated.
A complete and trustful system to manage design files of a medical device
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.
A deep system of traceability with a lot of practical features
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.
Response from Orcanos
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!
User friendly test management app , with quick customization and flexible environment
Integrated ALM for a growing medical device startup
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.
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.
Some annoying UI aspects that need improvement and rework (Great support from the Orcanos team though)
Traceability is key
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.
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.
I'd like to have more flexibility in creating word documents.
I'd like to have more tools in batch editing items.
Good Potential to become a major overall solution
working with the system for several years, the web version is a great improvement.
still much to do on the administration side (users/groups mgmt. & reports etc')
great support and care.
Intuitive, quite fast , customable, service & support
Administration management, Document generation app is not intuitive and filtering items isn't straight forward, some issues of stability
User experience with the Q-Pack software
Good usability and reliability.
Uploading documents and signing them works straight forward. The DMS items can be put into a hierarchy where the items show their current status (pending, accepted, rejected). We use the DMS for containing the technical documentation. All status information on each document are displayed. The document can be accessed. However, the representation of version information is not compatible to our document control rules.
+ Flexibility to structure the technical documentation
- Revision representation not compatible to version string used in our company
- No diff functionality for changes between two versions
All-in-one product, Requirement management, Risks, Test management, Traceability, Bugs, etc.
Control of the different components of the project
Traceability made simple in case of changes, history of changes to keep full control, Efficient dashboards, customized export templates
Need to enter documents from scratch, but now, thanks to new feature of "Import from Word", this constraint will disappear
Excellent one stop shop product
Generally easy to use software with self
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
Easy to quickly learn step by step all the steps and translate them on the day
Easy to maintain and preserve all documents
Lack of knowledge is the main obstacle to the use of the software and follow the development and using it
Response from Orcanos
Thank you Irith for reviewing ORCANOS e-DMS product and feedbacking us.
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
Design control tracability and risk managment
Interface not intuitive - need some training
Feedback on Orcanos system
I'm manage all the company documents in Orcanos system, the process of release ECOs, submissions and folders managements. procedures, forms. marketing materials, DHF...
The multi functions, the changes that you can do for the company's needs.
I don't have, Orcanos find me solution for my needs.
We love Qpack
Qpack is very easy to use and allows rapid implementation. Also, the flexibility to customize the system is a valuable system feature.
Response from Orcanos
Thak you for your warm review, it means alot to us. we are looking forward to work on more modules of the system.
Inserting and editing company regulatory documents, please see below:
Aesthetically appealing and easy-to-navigate
Efficient and effective
IT support is available via online chat
Unfortunately, I had to spend a long time in order to manually insert the regulatory documents into the Orcanos software, since the automatic insertion option(Drag & Drop) did not work for my document.