Cloud Document Control Software System (DMS), satisfies ISO 13485 and 21 CFR Part 11
Top DMS Features
Automated Document Control and Management
Automation of your documents lifecycle, such as Import, approve, distribute, and obsolescence. By automating document workflow, such as routing, approval, and distribution, you can assure that no task is overlooked, and document cycle time is reduced significantly while assuring compliance with regulations.
Web based User-Friendly Interface
Orcanos uses Google Material Design guidelines to assure the best user experience. Orcanos Document Control is structured hierarchically so it is similar to windows explorer layout. You can easily switch between a hierarchic view to the listview, with may navigations capabilities, such as search inside the tree, designate favorite items, last viewed items and more, using responsive uI, which fit the screen you're using, both for desktop, mobile, and tablets.
Workflows Automation End Electronic Signature
Orcanos online Document Management Software System will automate your workflows, route e-sign to the next signers, and provide real-time alerts
PDF Publishing On Signoff
Approved document is published to PDF, While Orcanos generates cover letter and adds watermarks to each page. While new revision is generated, previous revision is set to Obsolete. This enables users to preclude unauthorized printing, saving or copying of the documentation.
Automated Revision Control
Orcanos Document Management System manages revisions based on routing status, makes previous revisions obsolete and publish approved documents to PDF, while generating effective date and notify stakeholders
21 CFR Part 11 Compliance
Develop Medical Device? Orcanos DMS Online fully satisfies FDA 21 CFR Part 11 for electronic records and electronic signature
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
Custom DMS Dashboards And Analytics
Orcanos Document Control Analytics Engine enables building multiple dashboards and dashboard panels, to increase transparency.
Single Centralized ALM And QMS Repository
All departments, such as R&D, QA and RA login to a single centralized location for all documents and R&D information
After working with the Orcanos team on optimizing our development process, we often get them 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 things later.
MAZOR ROBOTICS
Orcanos Medical ALM Solution provides a platform to easily deal with complexities entailed in capturing and managing product requirements (system, software, hardware, mechanical, etc), risk management and traceability in a highly regulated environment.
FIO
Traceability from the cradle to the grave is the key to quality in our development of the most advanced Oncotherapy. Orcanos serves 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.
AVO-ADAMAVO
Start in 5 steps
Define Users And Roles
Build users and groups, assign roles and permissions for document authors and signers
Build routing process
Build routing process, workflows for documents approvals and signoff (Part 11 Compliant e-sign)
Import Your Documents
Use Orcanos Import tool to get all your existing repository in one click, to create your baseline
Create Baseline
All documents get an initial baseline - start routing and change management
No more paper work
ALM and 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 your e-sign processes (routing process) for documents approval, complying 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
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Contact
8Beit Oved Street
Tel Aviv, Israel
+972-3-5372561
info@orcanos.com
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