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ALM AND QMS

Integrating Design Control (ALM) with a quality management system and regulatory compliance in a central repository. A simple, Part 11 validated system that satisfies the needs of the QA RA and R&D departments, supports embedded products – Software, Hardware, and automates End to end traceability across entities. At any point, Orcanos enables you to generate data into Word documents and e-sign them in Orcanos DMS, or directly sign electronic records.

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Integrated Risk Management

Integrate risk into your development, and to your QMS, to assure full traceability, and save 30% of the resources spent on manual management.

Ensures hazards are mitigated and prevents failure from happening Generate Risk Management File in just one-click ISO 14971 Compliance

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Adaptive Compliance

Replace paper-based QMS with Orcanos customizable electronic forms, and achieve higher productivity and efficiency

  • Powerful customization tools, simple templates.
  • Support a wide variety of field types.
  • Build workflow routing for electronic signature (Part 11 Compliance)
  • Setup traceability between different e-forms
  • Setup form logic such as mandatory rules
  • Access control for Add/Edit/View to show/ hide form elements.
  • Integrate filters into field values.
  • No coding is required, drag and drop design
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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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Why you choose Orcanos

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!

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Your next electronic audit with Orcanos

Assure your success with the only system that combines your design control with Quality and Regulations

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