Compliance-Ready EQMS for Lifesciences
Discover how a custom-built, AI powered EQMS empowers Life Sciences organizations to ensure safety, quality, and precision. It simplifies navigating complex compliance requirements and accelerates innovation – all while maintaining customer trust and confidence.
Maintain the delicate balance between innovation, compliance, and operational excellence with Qualityze
In the high-stakes world of Life Sciences, where every decision impacts lives, ensuring product quality, patient safety, and regulatory compliance is mission-critical. But, keeping up with stringent global regulations like FDA 21 CFR Part 11 and EU MDR, maintaining data integrity, and accelerating time-to-market can be overwhelming. That’s why leading Life Sciences organizations trust Qualityze. Our AI-powered, cloud-based Enterprise Quality Management System (EQMS) transforms how you manage quality and compliance, making it simpler, smarter, and more efficient. Designed to streamline workflows, deliver real-time insights, ensure regulatory readiness, and integrate seamlessly with your existing quality systems, Qualityze empowers you to stay ahead of the competition while delivering safer, high-quality products with confidence.
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The Qualityze Difference Empowers You To:
Navigate Complex Regulatory Landscapes
Our robust solution simplifies compliance with global regulatory requirements like FDA 21 CFR Part 11, EU MDR, and ISO standards through pre-configured industry best-practices workflows, document control and comprehensive audit trails, enabling seamless adherence to evolving regulatory requirements.
Maintain Data Integrity and Traceability
Our cloud-based solution ensures centralized records management, better traceability, advanced security controls, and audit-ready records to help organizations maintain data integrity.
Mitigate Risks Proactively
With built-in risk management tools featuring configurable thresholds and integrated CAPA capabilities, our solution enables proactive identification and mitigation of risks. This ensures product quality, patient safety, and minimal disruptions with real-time analytics.
Drive Product Quality Excellence
Our next-generation quality management solution streamlines quality control processes with pre-defined checklists, configurable sampling plans, proactive input validation, and standardized workflows. It empowers you to maintain high standards and optimize operational control efficiently.
Ensure Supplier Quality and Transparency
Our EQMS facilitates end-to-end supplier quality management including supplier qualification, performance monitoring, supplier scorecards and centralized record management. This ensures transparency and compliance while driving consistency and continuous improvements across supply chains for better product outcomes.
Stay Audit and Inspection Ready
Our next-generation solution ensures consistent data collection, automated approvals, and offers real-time reporting, so you are always audit-ready and capable of managing business operations with minimal disruptions.
| Standard/Regulation | Description |
|---|---|
| ISO Standards | |
| ISO 13485 | Quality Management for Medical Devices |
| ISO 14971 | Risk Management for Medical Devices |
| ISO 9001 | General Quality Management System Requirements |
| ISO 31000 | Risk Management Principles and Guidelines |
| FDA Regulations | |
| 21 CFR Part 11 | Electronic Records and Signatures |
| 21 CFR Part 820 | Quality System Regulation for Medical Devices |
| 21 CFR Part 58 | Good Laboratory Practice (GLP) |
| 21 CFR Part 210/211 | Current Good Manufacturing Practice (cGMP) |
| GxP Guidelines | |
| GMP | Good Manufacturing Practices |
| GLP | Good Laboratory Practices |
| GCP | Good Clinical Practices |
| EU MDR and IVDR | |
| MDR | Medical Device Regulation |
| IVDR | In Vitro Diagnostic Regulation |
| ICH Guidelines | |
| ICH Q8 | Pharmaceutical Development |
| ICH Q9 | Quality Risk Management |
| ICH Q10 | Pharmaceutical Quality System |
| Pharmacovigilance Standards | |
| ICH E2E | Pharmacovigilance Planning |
| WHO Guidelines on Safety Monitoring | |
| EMA Good Pharmacovigilance Practices (GVP) | |
Reasons to choose Qualityze EQMS for Lifesciences Industry
Choosing Qualityze Enterprise Quality Management Solution will be a beneficial decision for the Lifesciences industry because it has
User-Friendly Interface
Simplifies usability with an intuitive design, requiring no technical expertise.Seamless Integration
Fits perfectly with your existing systems to enhance operational efficiency.Cloud-Based Platform
Provides secure, flexible, and anywhere-accessible data management.Automated Upgrades
Keeps you up-to-date effortlessly with automatic version upgrades.Configurable workflows and Fields
Adapts to your unique business processes with configurable options.Low Implementation Costs
Delivers a cost-effective solution without compromising on performance.Minimal Maintenance Needs
Eliminates hardware dependencies, offering easy access from any location.Flexibility and Security
Combines robust security with cloud-based flexibility to meet dynamic needs.AI-Powered Assistant
Offers intelligent support for proactive decision-making and streamlined workflows.The Start of Something Amazing.
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