ALM GAME CHANGER

The Only System That Combines ALM With Quality And Regulations

 

BIOSENSE
MAZOR ROBOTICS
FLEXTRONICS
NETAFIM
AIRSPAN
VALENS

 

AND MANY OTHERS HAVE ALREADY CHANGED THE WAY THEY ALM.

ALM And QMS

orcanos dms document control software system

A Collaborative ALM and Quality Management system, including Requirements Management Tools, Bug Tracking, Test Management, Document Control, Electronic CAPA Form, FMEA Risk Management, and much more. Orcanos satisfies acceptable standards such as ISO 14971, ISO 13485 and IEC 62304, and more, with the ability to electronically sign documents and records

Main Modules And Compliance

Requirements Management

 

Test Management

 

Defect Tracking

 

Service Center

Document Control

 

CAPA MAnagement

 

Complaint Management

 

Chnage Management

 

Training

 

Non-Conformities

21 CFR Part 11 Compliant

 

FDA 21 CFR Part 820

 

ISO 14971

 

ISO 13485:2016

 

IEC 62304

Our Clients Testimonials

“ORCANOS Medical provided a platform to easily deal with complexities entailed in capturing and managing of Product Requirements (System, Software, Hardware, Mechanical, etc) , Risks Management and Traceability in a highly regulated environment…”

Igor Stankovski

Technical Program Manager, Fio

“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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Eli Zehavi

Co-Founder, Mazor Robotics

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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…”

Integrating With 750+ Applications with Zapier

Key Features

ALM+QMS

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

Document Generator

Easily generate ready for submission documents from your database

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

Define electronic signature process for a complete documents approval lifecycle

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

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

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

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

Contact

8Beit Oved Street
Tel Aviv, Israel
+972-3-5372561
info@orcanos.com

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