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
Requirements Management Tool
Orcanos ALM Requirements tool allows you to plan, approve, trace and validate industry requirements, manage audits and ensure regulatory compliance, all within a seamless integration into a Microsoft Office environment.
Test Management Software
Effective testing is a critical part of the quality journey. Orcanos Testing Suite delivers everything that is needed for the verification and validation processes, all operating within a central ALM location. Orcanos Test Management tool enables companies to effectively track and monitor test results, generating these insights in digital formats such as Word, PDF and Excel.
Orcanos Defect Tracking system ensures that all project participants and stakeholders can submit, query, update and report defects easily, while delivering transparent traceability on product features and test cases.
21 CFR Part 11 Compliance
Orcanos ALM meets all the requirements of the FDA medical device compliance protocols for electronic records and electronic signature.
With just a few clicks, Orcanos Document Control Software system enables you to set up dynamic routing processes or workflows, form layouts, mandatory fields and sections, roles and permissions. Configuration is easy, and no programming or IT-centric skills are required.
We Have Your Back
Orcanos makes sure that no document is overlooked, no compliance or other due dates are missed and no preventable events occur. In fact, our system will alert end users and stakeholders every time a potential deviation from stated business goals is detected.
This is the moment when you
choose your way to success.
Single Repository for R&D Quality And Regulations
Orcancos ALM system provides a single data repository that combines research and development, quality management and compliance regulations. This means that companies can manage all required elements – testing, risk management, CAPA, change management et al – in one place.
Product database can be shown in a variety of custom templates, all of which can include tables, visual images and embedded dynamic data sets.
System includes a simple and powerful tool – Traceability Matrix Management – that allows interaction between any ALM or QMS artifact during the process. This includes but is not limited to project requirements, test cases, FMEA risk items, CAPA and customer complaints.
Orcanos will issue notifications to end users when any change impact is detected via our filters and alerts mechanism.
Just Start Working …
The system is powerful, complete and provides the support that medical device companies, but its complexity is balanced by how simple the solution is to apply, connect and run.
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.
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.
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.
Say Goodbye to Paper
Combine design control with quality and regulation in a central repository for better collaboration
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
Define e-sign processes (routing process) for documents apporval, comply with 21 CFR Part 11.
Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity), E-signature processes, status flows, mandatory rules and permissions
Build custom reports and charts to track cross-projects/cross-department reports, such as requirements traceability, test run results, risk status, CAPA and more
Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability
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