ALM AND QMS

Integrating Design Control (ALM) with a quality management system and regulatory compliance in a central repository. A simple, Part 11 validated system that satisfies the needs of the QA RA and R&D departments, supports embedded products – Software, Hardware, and automates End to end traceability across entities. At any point, Orcanos enables you to generate data into Word documents and e-sign them in Orcanos DMS, or directly sign electronic records

INTEGRATED RISK MANAGEMENT

Integrate risk into your development, and to your QMS, to assure full traceability, and save 30% of the resources spent on manual management.

Ensures hazards are mitigated and prevents failure from happening

Generate Risk Management File in just one-click

ISO 14971 Compliance

CUSTOMIZED E-FORMS

Replace paper-based QMS with Orcanos electronic forms, and achieve higher productivity and efficiency

• Powerful customization tools, simple templates.
• Support a wide variety of field types.
• Build workflow routing for electronic signature (Part 11 Compliance)
• Setup traceability between different e-forms
• Setup form logic such as mandatory rules
• Access control for Add/Edit/View to show/ hide form elements.
• Integrate filters into field values.
• No coding is required, drag and drop design

Key Features