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.
Develop Medical Device? Orcanos ALM fully satisfies FDA 21 CFR Part 11 for electronic records and electronic signature
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.
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
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 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
Generate your database into custom templates, including tables, images, and embedded dynamic data
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.
Get alerts for any change impact on your project using Orcanos filters and alerts mechanism
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.
Combine design control with quality and regulation in a central repository for better collaboration
Easily generate ready for submission documents from your database
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