Application Lifecycle Management

Manual Traceability is time-consuming?

Risk mitigations traceability is breaking up?

What is the true impact analysis of a change?

Secured, Robust and Simple ALM Platform

gohnson & gohnson
Mazor Robotics
Haldor
Zimmer
Biosense Webster
Fio Corporation

Features

Requirements Management Tool

Orcanos ALM Requirements Management tool allows you to plan, approve, trace and validate requirements, manage any audit, compliance or regulatory and integrate into your office environment.

21 CFR Part 11 Compliance

Develop Medical Device? Orcanos ALM fully satisfies FDA 21 CFR Part 11 for electronic records and electronic signature

Test Management Software

Orcanos Testing Suite for test management provides all you need for your verification and validation processes. Operates over Orcanos ALM central repository, Orcanos Test Management Tool allows tracking, and monitoring of test results, and generate your test results into Word, PDF, Excel and more.

Simple Configuration

Orcanos Document Control Software system allows you to set up dynamic routing process (workflow), forms layout, fields and sections, roles & permissions, with just few clicks, no programming or special skills are required

Defect Tracking

Orcanos Defect Tracking system allows all project participants to easily submit, query, update, and report defects, while making transparent traceability to features and test cases

Orcanos Is Watching Your Back

Orcanos will make sure no document is overlooked, due dates are not missed ar any other rue you define - Orcanos will fire alert and notify you for every deviation of your business goals

This is the moment when you
choose your way to succes.

Benefits

document management software system

Single Repository for R&D Quality And Regulations

Orcanos system provides you with a single ALM repository that combines R&D with quality and regulations. Manage your requirements, testing, along with risk management, CAPA, change management and much more

Document Generation

Generate your database into custom templates, including tables, images, and embedded dynamic data

End-To-End Traceability

simple and powerful for Traceability Matrix Management between any ALM or QMS artifact, such as requirements, test cases, FMEA Risk items, Customer Complaints, CAPA and more.

Impact Analysis

Get alerts for any change impact on your project using Orcanos filters and alerts mechanism

Just Start Working

A powerful and complete system, but yet - it's quite simple to get started.

Dramatically Increase Your Employee Engagement & Productivity

After working with Orcanos on optimizing our development process, we often get their team involved strategically when we are about to start a new project, or when we assemble a new team. Our experience taught us that it is better to start on the right foot than try to fix it later.

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Mazor Robotics
MAZOR ROBOTICS

The Orcanos Medical ALM Solution provides 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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FIO
FIO

Traceability from the cradle to the grave is the key to quality in our development of the most advanced Oncotherapy. Orcanos provides us this tracking ability, and gives us high flexibility, comprehensive reports, and good office collaboration world wide on top of our existing disjoint systems. This enables us at the AVO-ADAM to live our workflow.

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AVO ADAMAVO
AVO-ADAMAVO

No More Paper Work

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

Integrating risk into your development ensures that 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-signature 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

Manage Your ALM From Start To Finish

Israel

8, Beit Oved Street
Tel Aviv
Israel
+972-3-5372561

sales@orcanos.com

Europe

Huizingalaan 69
3572LJ Utrecht
Holland
+31 85 1046614

henk@persistency.nl

Orcanos

Contact

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

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