Where Quality, Clinical, and Engineering Data Come Together
NetRegulus: NetRMtm Enterprise Software
NetRegulus connects Clinical Studies, Quality Assurance, and Product Data Management
There now exists a paradigm shift in your regulatory world, one where Quality Assurance, Regulatory Compliance and Product Data events are linked into one integrated database…….one single source of truth. From any computer worldwide and in virtually any language, NetRM covers your product from early-phase studies to post-market surveillance.
Intuitive Interface
Through a web-based configurable solution called NetRegulus, we provide a single source of truth that manages all quality, and regulatory data across every level of involvement. Intelligent report forms and templates are easy to build and reuse within user-specific groups. All events are 21CFR Part 11 and 820 (series), and ISO 13485 compliant, and FDA submissions are expedited efficiently. This is a powerful tool with multi-lingual capabilities that is incredibly easy to use. Install NetRegulus on-site or utilize Software as a Solution (SaaS), saving upfront investments in time and resources and speeding your product to market even further
Total Life Data Management
When combined with the Windchill data management system, NetRegulus provides an end-to-end solution that will help satisfy the FDA’s Total Product Life Cycle approach, allowing you to continuously monitor and advance product quality and innovation. This solution adds tremendous value to your workflow and is now available to companies of all sizes
Strategic Outcome Based Technology
We can make a big difference for your company. Let’s get together to discuss NetRegulus in further detail. We know you’ll be interested in learning how we’ve helped other firms achieve significant results.
Video Demonstrations:
You will NOT be required to complete a form to view these videos.
NetRegulus NetRM for Quality Management (12min 36sec)
NetRegulus NetRM for Study Managment (14min 38sec)
Information:
Quality:
NetRegulus NetRM Capa Module Data Sheet (PDF)
NetRegulus NetRM Complaints Module Data Sheet (PDF)
NetRegulus NetRM Non-Conformance Module Data Sheet (PDF)
Study:
NetRegulus NetRM CRF Builder Module Data Sheet (PDF)
NetRegulus NetRM CRF Administrator Module Data Sheet (PDF)
NetRegulus NetRM Study Administrator Module Data Sheet (PDF)
NetRegulus NetRM Study Data Manager Module Data Sheet (PDF)
NetRegulus Overview Brochure (PDF)
White Paper: Managing the Medical Device Total Product Life Cycle (PDF)
Article Reprints:
Appliance of Science
Apraising Compaint System Effectiveness
From Data to Drugs: New Solutions Open the Doors on Drug Development
Strategic Insights: The Quality System Edge
The Goldilocks Principle: Approaches to Software Validation
