Regulatory compliance
QFacts provides a comprehensive, audit-ready platform that helps pharma companies comply with FDA 21 CFR Part 11, GxP, GAMP 5 & other global regulatory frameworks. From document control to training, change management, and CAPA, every process is designed to meet the highest compliance standards.
Lean workflows
Based on our experience in both small and large Life Sciences companies, we have refined our workflows to embody the essence of a lean quality process. QFacts integrates industry best practices while offering the flexibility to align with your specific needs.
The workflow is readily visualized for each end user to show which actions need to be performed.
Admin Center
QFacts empowers you with a centralized Admin Center, allowing you to configure critical settings tailored to your organization. Adjust impact levels for investigations, set due dates, define record review parameters, and more – all without unnecessary complexity. Our pre-configured settings, based on industry expertise, ensure a seamless start.
Intuitive user experience
We know that many users outside the QA department interact with an eQMS only occasionally. That’s why QFacts is designed for simplicity. Each screen features one clear call-to-action button, ensuring that users always know what to do next. No clutter, no confusion – just a streamlined experience.
Fully validated & auditable
QFacts is a plug-and-play, GAMP validated platform, ensuring compliance from day one. No need for extensive validation efforts – our system is ready to support your regulatory requirements. Every record in QFacts includes a detailed timeline, providing a transparent audit trail. Maintain full oversight of changes, actions, and approvals for easy traceability.
Get in touch
Get in touch for a live demo or more information! We guarantee we will ease your life.