Description
Key Features and Benefits
- Regulatory Compliance – Designed to meet FDA, ISO, and global regulatory requirements, ensuring seamless audits and compliance.
- Integrated Document & Training Management – Automates document approvals, tracks training completion, and ensures compliance readiness.
- Advanced CAPA & Change Management – Helps businesses quickly address quality events and implement corrective actions.
- Audit & Risk Management – Ensures organizations stay proactive in managing risks and preparing for regulatory inspections.
- Workflow Automation – Reduces manual tasks with pre-configured workflows for quality events, deviations, and approvals.
- Real-Time Data & Analytics – Provides actionable insights into quality trends, compliance status, and operational performance.
- Cloud-Based Accessibility – Enables remote access and seamless integration with Microsoft Word, Excel, and PowerPoint.
Key Differentiators
- Purpose-Built for Life Sciences – Unlike generic QMS software, MasterControl Qx is optimized for pharmaceuticals, biotech, and medical devices.
- Automated Compliance Tracking – Ensures adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 11, and GMP requirements.
- Strong Industry Adoption – Trusted by over 1,100 organizations in life sciences and other regulated sectors.
- Customizable & Scalable – Allows businesses to configure workflows and expand features as their needs evolve.
- Proven Customer Support & Training – Offers extensive support, training modules, and consulting services for rapid implementation.
