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Regulations

Regulations

Design Control

Design Control

Quality Management

Quality Management

Employee training is critical for successful ongoing business practices and effective employee engagement. In a quality culture, driven by the need for continuous improvement, training management software is essential to meeting your business and quality goals.

Orcanos Training Management Software automates and training management processes.

The fact that Orcanos is an integrated quality management system (e-QMS) allows to natively link training plans and training tasks to other quality processes.

Using Orcanos powerful filter module, and the customized dashboard, allows better tracking of your training tasks, and the electronic signature enables the employee to sign a training task upon completion.

Using the Orcanos Studio for building and customizing electronic form enables simple customization of training task forms, with the ability to add new custom fields and rules to support company SOP

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No More Paper Work

ALM+QMS

ALM+QMS

Combine Design Control (ALM) with quality management system and regulation in a central repository

Document Generator

Document Generator

Easily generate ready for submission documents from your database

Integrated Risk Management

Integrated Risk Management

Integrate risk into your development, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971

21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

Define electronic signature process for a complete documents approval lifecycle

Easy Customization

Easy Customization

Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity…), E-sign processes, status flows, mandatory rules and permissions

Dashboards And Analytics

Dashboards And Analytics

Better tracking and control with custom reports and charts builder, to track projects progress and quality procedures status, such as requirements traceability, test run results, risk assessment, CAPA and more

End To End Traceability

End To End Traceability

Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability

Realtime Alerts

Realtime Alerts

Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents. Alerts are automatically fired once a day/week

Your virtual Auditor

Your virtual Auditor

Use Orcanos Compliance Engine to get a real-time audit of your projects, anywhere, anytime!

What our client say about us

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

Tsvika - System and Software QA Manager Medical Devices

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

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"Using ORCANOS for Medical Devices"

Gerd E - Lead System Architect

One database, one tool and user interface for requirement-, risk-, test-, CAPA-management etc. Item based!!! with the possibility to generate documents on each level. No need to manage interfaces , relatively fast to configure for own needs, without writing and validation of user-ware. 100% cloud based and platform independent.

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"My major tool for conformity."

Stephen - QA Manager

The simple and easy way of controlling documentation. Time saving and ease when undergoing audits by Notified Bodies. Traceability when it comes to CAPA and ECO's.

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"I love the flexibility of Orcanos!"

Stuart H

I love the flexibility of Orcanos! It feels like the system is almost 100% configurable, so whenever I think 'it would be nice to do this' then I can always do it within the system. The traceability function is awesome too, it means that we can link our items together so that we can get an overview of the project from top to bottom.

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"Orcanos gives use Excellent solution"

Linor V - Document Controller

Flexibility, Fit our needs, Fest answer and

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Igor Stankovski

Technical Program Manager, Fio

The Orcanos medical ALM solution provides us with a platform to easily deal with complexities entailed in capturing and managing product requirements (system, software, hardware, mechanical, etc.), risks management and traceability in a highly regulated environment.

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Eli Zehavi

Co-Founder, Mazor Robotics

Orcanos ALM allows us to build our business strategy KPI’s and see the quality of our processes and the efficiency of our program execution to meet the market demands…

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Oren Tamari

CEO, Upnride

…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…

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G2 Recognized Orcanos

Read review from our happy customers

PRICING PLAN

No Hidden Charges! Choose
your Plan.

$ 0

$ 0

Basic Account

Only for first month

Only for one year

  • Limited Acess Library
  • Single User
  • eCommerce Store
  • Hotline Support 24/7
  • No Updates

$ 75.40

$ 29.50

STANDART ACCOUNT

Only for first month

Only for one year

  • Limited Acess Library
  • Single User
  • eCommerce Store
  • Hotline Support 24/7
  • No Updates

$ 140.60

$ 75.30

PREMIUM ACCOUNT

Only for first month

Only for one year

  • Limited Acess Library
  • Single User
  • eCommerce Store
  • Hotline Support 24/7
  • No Updates

FREQUENTLY ASK QUESTION

Want to ask something from us?

Yes, we would be happy to demonstrate Orcanos ALM through a web-conference at your convenience. The demo can take 45-60 minutes depending on your needs. To schedule a session, please contact us at [email protected].

We accept payment via credit cards, PayPal, and bank transfer.

For more details, please contact [email protected]

No. You can to select a package based on your needs (Design Control or QMS), where the Premium package includes EVERYTHING.

It means all users belong to the same package

Orcanos ALM is a pay-as-you-go service (monthly or yearly). This means there are no long-term contracts. You can choose to upgrade, downgrade, or cancel your subscription at any time by logging into your Orcanos ALM account or contact us by email at [email protected].

This is a set of validation documetns  (Requirements Spec, Test Design and Tst results) that you get along with our software, and on each upgrade. They are the proof that the software was validated, and that it is Part 11 Compliant

Your data safe and secured. Orcanos is hosted at AWS and apply the strictest security controls. We have a backup procedure running every 15 minutes. Backup snapshot is encrypted and stored on different servers.

Learn more about the Orcanos Security Center

Yes. If you wish to have users that are read only, it’s possible. Contact us for more details

Yes, you can. To switch plans, please contact us.

Yes, it is. You have a full validation package as part of Orcanos system.

No. One of Orcanos’ advantages, is that you have a virtual environment and YOU get to decide if and when to upgrade your account to a newer versions. This is most critical for regulated companies such as medical device manufacturers.

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Your next electronic audit with Orcanos

Assure your success……

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