ALM GAME CHANGER

BEYOND TASK MANAGEMENT, DOCUMENT CONTROL, AND TRACEABILITY

 

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

Key Features

ALM+QMS

combine Design Control with quality and regulation in a central repository for better collaboration

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

Electronic Signature

Define e-sign processes (routing process) for documents apporval, comply with 21 CFR Part 11.

Fully Customizable

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

Personal Dashboards

Build custom reports and charts to track cross-projects/cross-department reports, such as requirements traceability, test run results, risk status, CAPA and more

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Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents.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

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…”

Contact

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

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