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Orcanos ALM est une solution abordable pour la gestion des exigences et des tests. Elle intègre également la gestion de la qualité au processus de développement.

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Tsvika F.
Tsvika F.
System and Software QA Manager (Israël)
Utilisateur LinkedIn vérifié
Appareils médicaux, 11-50 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

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

5 il y a 3 ans

Commentaires : 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

Avantages :

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.

Inconvénients :

Some features like Customer Complaint still requires a desktop application for generating document report.

Shlomit H.
SQA Manager (Israël)
Appareils médicaux, 11-50 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

Your project needs in one product

4 il y a 2 ans

Commentaires : Although project setup might take some time and effort, the overall project day-to-day management is easy and saves time.

Avantages :

This product is likely to provide your project needs in the best possible way

Inconvénients :

Document Export feature - it needs improvement

Alternatives envisagées : Jira

Pourquoi passer à Orcanos : The ability to handle all project aspects in one product

Daphna R.
Director of clinical affairs (Israël)
Appareils médicaux, 11-50 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

In my user experience the product is not sufficiently QA tested

3 il y a 8 mois

Avantages :

i liked most that it is easy to use and implement.

Inconvénients :

Release of new versions is not QA sufficiently

Utilisateur vérifié
CTO (Israël)
Utilisateur LinkedIn vérifié
Hôpitaux et soins de santé, 11-50 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

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

5 il y a 4 ans

Avantages :

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

Inconvénients :

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 H.
Quality Manager (R.-U.)
Produits pharmaceutiques, 2-10 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Would recommend using this QMS

5 il y a 2 ans

Commentaires : 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.

Avantages :

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.

Inconvénients :

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 R.
CTO (R.-U.)
Appareils médicaux, 2-10 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Medical device QMS with Orcanos

4 il y a 2 ans

Commentaires : 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.

Avantages :

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.

Inconvénients :

The training module is overly complex, but this is being updated.

Cedric N.
R&D manager (France)
Appareils médicaux, 11-50 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

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

5 il y a 2 ans

Commentaires : 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.

Avantages :

A deep system of traceability with a lot of practical features

Inconvénients :

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.

Réponse de l'équipe de Orcanos

il y a 2 ans

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 K.
Director System Verification (Israël)
Télécommunications, 501-1 000 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

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

4 il y a 4 ans

Avantages :

Flexible Quick Customization for personal needs Fast technical support Support of advanced filters using SQL DB

Inconvénients :

Slowness on the product tree views Not all filters exposed to regular user (some advanced filters supported only for advanced SQL users)

Yaron L.
VP R&D (Inde)
Hôpitaux et soins de santé, 2-10 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Traceability is key

4 il y a 5 ans

Commentaires : 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.

Avantages :

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.

Inconvénients :

I'd like to have more flexibility in creating word documents. I'd like to have more tools in batch editing items.

Almog A.
CEO & VP R&D (Israël)
Biotechnologie, 11-50 employés
Temps d'utilisation du logiciel : 1 à 5 mois
Source de l'avis

Integrated ALM for a growing medical device startup

5 il y a 2 ans

Commentaires : 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.

Avantages :

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.

Inconvénients :

Some annoying UI aspects that need improvement and rework (Great support from the Orcanos team though)

Dotan S.
System analys (Israël)
Appareils médicaux, 51-200 employés
Temps d'utilisation du logiciel : plus d'un an
Source de l'avis

Good Potential to become a major overall solution

4 il y a 5 ans

Commentaires : 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.

Avantages :

Intuitive, quite fast , customable, service & support

Inconvénients :

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

Michal V.
VP QA (Israël)
Appareils médicaux, 11-50 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

User experience with the Q-Pack software

5 il y a 2 ans

Avantages :

The Q-Pack software is very easy to use.

Inconvénients :

Sometime we have some bugs but the Orcanos custoomer support use to resolve it.

Veronique J.
Qa Consultant (Italie)
Appareils médicaux, 2-10 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Orcanos review

4 il y a 3 ans

Commentaires : 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

Avantages :

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

Inconvénients :

Still need some adaptations. To cover all qms needs.

Ingo W.
Head of Research and Development (Allemagne)
Appareils médicaux, 2-10 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Good usability and reliability.

4 il y a 5 ans

Commentaires : 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.

Avantages :

+ Flexibility to structure the technical documentation + Clearness

Inconvénients :

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

Grace F.
V&V Manager (Israël)
Appareils médicaux, 11-50 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

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

5 il y a 4 ans

Commentaires : Control of the different components of the project

Avantages :

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

Inconvénients :

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

Tal B.
Tal B.
Technical Manager (Israël)
Utilisateur LinkedIn vérifié
Appareils médicaux, 11-50 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Excellent one stop shop product

5 il y a 3 ans

Avantages :

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

Inconvénients :

BOM management is yet not mature enough.

Irith B.
QA Suppervisor (Israël)
Appareils médicaux, 51-200 employés
Temps d'utilisation du logiciel : 1 à 5 mois
Source de l'avis

Generally easy to use software with self

4 il y a 5 ans

Commentaires : 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

Avantages :

Easy to quickly learn step by step all the steps and translate them on the day Easy to maintain and preserve all documents

Inconvénients :

Lack of knowledge is the main obstacle to the use of the software and follow the development and using it

Réponse de l'équipe de Orcanos

il y a 5 ans

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

Kobi H.
QA Mng (Israël)
Appareils médicaux, 11-50 employés
Temps d'utilisation du logiciel : 1 à 5 mois
Source de l'avis

User expirience

5 il y a 3 ans

Commentaires : 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

Avantages :

Design control tracability and risk managment

Inconvénients :

Interface not intuitive - need some training

Linor V.
Documents Controller (Israël)
Appareils médicaux, 201-500 employés
Temps d'utilisation du logiciel : 1 à 5 mois
Source de l'avis

Feedback on Orcanos system

5 il y a 3 ans

Commentaires : I'm manage all the company documents in Orcanos system, the process of release ECOs, submissions and folders managements. procedures, forms. marketing materials, DHF...

Avantages :

The multi functions, the changes that you can do for the company's needs.

Inconvénients :

I don't have, Orcanos find me solution for my needs.

Aritz L.
Cofounder (Espagne)
Appareils médicaux, 2-10 employés
Temps d'utilisation du logiciel : 1 à 5 mois
Source de l'avis

Deneb Medical

4 l’année dernière

Avantages :

Traceability of every action and document

Inconvénients :

Not easy to get started with the system adapted to our needs

Elliot S.
Israël
Temps d'utilisation du logiciel : Non fourni
Source de l'avis

We love Qpack

4 il y a 5 ans

Commentaires : Qpack is very easy to use and allows rapid implementation. Also, the flexibility to customize the system is a valuable system feature.

Réponse de l'équipe de Orcanos

il y a 5 ans

Hi Elliot, Thak you for your warm review, it means alot to us. we are looking forward to work on more modules of the system. Rami

Liron E.
QA (Israël)
Temps d'utilisation du logiciel : 1 à 5 mois
Source de l'avis

Inserting and editing company regulatory documents, please see below:

5 il y a 4 ans

Avantages :

Simple Login Aesthetically appealing and easy-to-navigate Intuitive Efficient and effective IT support is available via online chat

Inconvénients :

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.

Peretz B.
Israël
Temps d'utilisation du logiciel : Non fourni
Source de l'avis

Peretz from valens

4 il y a 5 ans

Commentaires : 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