Automation of your documents lifecycle, from initiation to approve, distribute, and obsolescence. By automating document workflow, you can assure that no document is overlooked, and document cycle time is reduced significantly while assuring compliance with regulations.
Orcanos DMS is part 11 compliant
Approved document is published to PDF, While Orcanos generates cover letter and adds watermarks to each page. When a new revision is generated, previous revision is set to Obsolete, and Orcanos adds watermark accordingly. This enables users to preclude unauthorized printing, saving or copying of the documentation.
Orcanos Document Control Software system allows importing your entire file system into Orcanos central repository, in just a few clicks, so you can start working immediately.
All stakeholders, whether its R&D, QA, RA or management, working with a single repository system that combines it all together document Control, CAPA, Change Control, Risk Management, Requirements Management, and more
Orcanos Document Management System controls document revision and reduces the hassle of setting revisions manually. It handles completely the approvals, obsolete documents, effective dates, etc. and sends alerts to relevant stakeholders
Orcanos Document Control Analytics Engine enables building multiple dashboards and dashboard panels, to increase transparency.
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.
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.
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.
Build users and groups, assign roles and permissions for document authors and signers
Build routing process, workflows for documents approvals and signoff (Part 11 Compliant e-sign)
Use Orcanos Import tool to get all your existing repository in one click, to create your baseline
All documents get an initial baseline - start routing and change management
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 your e-sign processes (routing process) for documents approval, complying with 21 CFR Part 11.
Powerful customization tools to customize your quality forms (CAPA, ECO, non-conformity…), e-sign 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