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ALM en QMS

Geïntegreerd ALM en Quality Management systeem dat Requirements Management, Test Management, Document Control, CAPA, Risk Management en Service calls ondersteunt Het gebruik van Orcanos vermindert het risico van uw volgende audit en zorgt voor een betere productlevering

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ALM/ DESIGN CONTROL

  • Requirements Management
  • Test Management
  • Defect Tracking
  • Customer Service

QUALITY MANAGEMENT

  • Document Control
  • CAPA Management
  • Service calls
  • Training
  • Non-Conformities

REGULATIONS

  • 21 CFR Part 11
  • FDA 21 CFR Part 820
  • ISO 14971
  • ISO 13485:2016
  • IEC 62304

What our client say about us

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Igor Stankovski

Technical Program Manager, Fio

Tosser nancy boy super tickety-boo lemon squeezy easy peasy quaint, hunky-dory baking cakes pear shaped butty do one, it's all gone to pot chinwag I cuppa Eaton. Porkies amongst cockup absolutely bladdered cobblers.!

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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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Integrating To 750+ Applications with Zapier

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

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Your next electronic audit with Orcanos

Assure your success……

Schedule Demo
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