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Regulations

Regulations

Design Control

Design Control

Quality Management

Quality Management

Introduction

In the medical device industry, compliance with regulations and maintenance of high quality standards are of utmost importance. However, managing and tracking employee training can be a complex and time-consuming process. Our training management system is specifically designed to address these challenges, providing a comprehensive solution to streamline and optimize training processes.

The challenges involved in manual training management

Orcanos Document Control Software allows you to manage documents seamlessly from creation to revision control, approval, sign-off, distribution, training automation, and storage. The platform is robust and flexible, capable of managing all types of documents, including SOPs, work instructions, policies, DHF, and more.

Explore the Key Features of Orcanos Training Management System

Orcanos training management system is a powerful tool that enables medical device companies to manage, track, and report on employee training in a centralized and efficient manner. With our system, employees can easily track their training tasks and get notified when a new document is released, requiring their read and understand, while managers can monitor progress and ensure compliance.

Key Feature of our system includes:

  • Powerful customization tools and simple templates.
  • No coding is required; simply drag and drop
  • Support a wide variety of field types.
  • Build custom workflows in just a few clicks.
  • Setup traceability between different artifacts
  • Setup form logic such as mandatory rules
  • Complete access control

Training Matrix, Read and understand training tasks

One of the key features of the Orcanos Training Management System is the ability to easily build a training matrix that links specific documents with the relevant stakeholders that need to be notified when a new revision is released. This means that when a new version of a document is published, the system automatically assigns Read & Understand training tasks to the appropriate stakeholders based on the predefined matrix.

This process is fully automated, meaning that the system will automatically assign Read & Understand tasks to the relevant stakeholders based on the predefined matrix. This saves managers time and reduces the risk of human error.

Training notifications and aerts

Once a training task is assigned, stakeholders are notified on a daily basis of the self-reading tasks they need to complete. This ensures that everyone is aware of their training responsibilities and can complete them in a timely manner.
This ensures that all relevant stakeholders are informed of any changes or updates to the documents they need to know about, reducing the risk of errors and misunderstandings.

Benefits

Our system is designed with the unique needs of the medical device industry in mind, offering benefits such as:

  • Simplified training management processes, saving time and reducing complexity
  • Increased compliance with regulations and quality standards
  • Customizable and scalable to meet the needs of any organization, regardless of size or complexity
  • Saves time and reduces administrative tasks
  • Enhanced employee engagement and productivity through an intuitive and user-friendly interface.

Explore our training management solution further and experience how Orcanos can bring your training management to life.

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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. 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.

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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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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 documents  (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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