Orcanos

4.3 (35)
Compliance for Design Control, Risk and Quality Management

Overall rating

4.3 /5
(35)
Value for Money
4.4/5
Features
4.2/5
Ease of Use
4.3/5
Customer Support Software
4.3/5

89%
recommended this app
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35 Reviews

Tsvika
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 9.0 /10

Very good value for money, very helpful with preparations for audits

Reviewed on 2019-01-17

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.

Ori
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Great SW

Reviewed on 2022-09-04

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

Hadas
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 11-50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 5.0 /10

Mainly document control

Reviewed on 2022-09-19

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)

adar
Overall rating
  • Industry: Mental Health Care
  • Company size: 11-50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 7.0 /10

Review

Reviewed on 2022-09-11

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

Hagai
Overall rating
  • Industry: Medical Devices
  • Company size: 51-200 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 9.0 /10

Orcanos Usage review

Reviewed on 2022-09-07

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.

Noga
Overall rating
  • Industry: Medical Devices
  • Company size: 51-200 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 9.0 /10

Helpful software

Reviewed on 2022-09-07

Pros

the option to collaborate and simultaneously work as a team on a certain project.

Cons

The tracing mode is sometimes confusing.

Yehuda
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Orcanos standard user

Reviewed on 2022-09-07

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

Eleanor
Overall rating
  • Industry: Medical Devices
  • Company size: 51-200 Employees
  • Used Weekly for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 7.0 /10

Orcanos: Reliable and Thorough Document Storage

Reviewed on 2022-09-06

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.

Verified Reviewer
Overall rating
  • Industry: Biotechnology
  • Company size: 51-200 Employees
  • Used Weekly for 1-5 months
  • Review Source

Overall rating

  • Ease of Use
  • Likelihood to recommend 7.0 /10

Orcanos is great for retaining documents and getting them to the right people

Reviewed on 2022-09-01

Pros

Orcanos offers many useful functions, such as linking between documents and routing signatures.

Cons

Orcanos is often difficult to navigate. It'd be helpful to have a master bucket to search for relevant documents to a certain topic.

Dana
Overall rating
  • Industry: Medical Devices
  • Company size: 2-10 Employees
  • Used Weekly for 1-5 months
  • Review Source

Overall rating

  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 7.0 /10

Great customer service

Reviewed on 2022-09-06

Pros

After learning the basics of the system use, it becomes a very comfortable platform to manage the quality system.

Cons

It takes time to understand the options and the system, not very intuitive.

Verified Reviewer
Overall rating
  • Industry: Hospital & Health Care
  • Company size: 11-50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

A great integrated ALM and QMS, perfect for us as a small company

Reviewed on 2018-01-10

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

Stuart
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 2-10 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 9.0 /10

Would recommend using this QMS

Reviewed on 2019-08-22

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.

Jason
Overall rating
  • Industry: Medical Devices
  • Company size: 2-10 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Medical device QMS with Orcanos

Reviewed on 2019-12-06

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.

Shlomit
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Weekly for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Your project needs in one product

Reviewed on 2019-09-24

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

Reasons for Switching to Orcanos

The ability to handle all project aspects in one product
CEDRIC
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Weekly for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

A complete and trustful system to manage design files of a medical device

Reviewed on 2020-05-08

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.

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!

Zohar

Ariel
Overall rating
  • Industry: Telecommunications
  • Company size: 501-1,000 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

User friendly test management app , with quick customization and flexible environment

Reviewed on 2018-05-13

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)

Yaron
Overall rating
  • Industry: Hospital & Health Care
  • Company size: 2-10 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 9.0 /10

Traceability is key

Reviewed on 2017-01-12

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.

Dotan
Overall rating
  • Industry: Medical Devices
  • Company size: 51-200 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Good Potential to become a major overall solution

Reviewed on 2017-04-04

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.

Pros

Intuitive, quite fast , customable, service & support

Cons

Administration management, Document generation app is not intuitive and filtering items isn't straight forward, some issues of stability

Almog
Overall rating
  • Industry: Biotechnology
  • Company size: 11-50 Employees
  • Used Weekly for 1-5 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Integrated ALM for a growing medical device startup

Reviewed on 2019-09-19

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)

Michal
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 9.0 /10

User experience with the Q-Pack software

Reviewed on 2019-11-26

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.

Veronique
Overall rating
  • Industry: Medical Devices
  • Company size: 2-10 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 6.0 /10

Orcanos review

Reviewed on 2019-02-03

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

Pros

Easy to use for instored "modules". Can issue reports. Signature process easy.

Cons

Still need some adaptations. To cover all qms needs.

Ingo
Overall rating
  • Industry: Medical Devices
  • Company size: 2-10 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Good usability and reliability.

Reviewed on 2016-11-08

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.

Pros

+ Flexibility to structure the technical documentation
+ Clearness

Cons

- Revision representation not compatible to version string used in our company
- No diff functionality for changes between two versions

Grace
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Weekly for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 9.0 /10

All-in-one product, Requirement management, Risks, Test management, Traceability, Bugs, etc.

Reviewed on 2017-11-26

Control of the different components of the project

Pros

Traceability made simple in case of changes, history of changes to keep full control, Efficient dashboards, customized export templates

Cons

Need to enter documents from scratch, but now, thanks to new feature of "Import from Word", this constraint will disappear

Tal
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Excellent one stop shop product

Reviewed on 2019-01-17

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.

irith
Overall rating
  • Industry: Medical Devices
  • Company size: 51-200 Employees
  • Used Daily for 1-5 months
  • Review Source

Overall rating

  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 7.0 /10

Generally easy to use software with self

Reviewed on 2016-11-07

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

Response from Orcanos

Thank you Irith for reviewing ORCANOS e-DMS product and feedbacking us.