Discover how our AI-driven, cloud-based EQMS can help you ensure audit-readiness and patient safety. Our EQMS is designed to help you centralize data, automate compliance tasks, and improve patient outcomes—all on a secure, cloud-based platform. Read on to see how we empower healthcare excellence every step of the way.
Healthcare is built on trust, and trust begins with quality. Qualityze offers a comprehensive suite of smarter quality solutions designed to meet the unique challenges of the healthcare industry, from managing clinical trials to ensuring compliance with Good Clinical Practices (GCP) and pharmacovigilance requirements. Our cloud-based, AI-driven solutions provide real-time insights, centralized data management, and seamless integration with your existing systems. Let us help you elevate your quality management practices and exceed the expectations of patients, regulators, and stakeholders alike.
Proactively manage patient safety with centralized incident reporting, root cause analysis, and automated workflows for corrective actions. Our EQMS ensures compliance with safety standards, reduces errors, and improves accountability, empowering you to prioritize patient well-being.
Stay ahead of evolving regulations like HIPAA, FDA 21 CFR Part 820, and EU MDR/IVDR. Our solution offers pre-configured compliance workflows, automated approvals, and audit trails to simplify adherence to stringent healthcare standards.
Ensure the highest levels of data security and privacy with features like encryption, role-based access controls, and compliance with regulations like GDPR and HIPAA. Our EQMS integrates seamlessly with healthcare systems to protect sensitive patient information.
Reduce the risk of malpractice and product liability with centralized documentation, proactive risk assessments, and automated compliance checks. Our EQMS provides the tools you need to minimize legal and financial vulnerabilities.
Ensure continuous learning and skill development with our integrated Training Management module. Keep your workforce prepared for new regulatory requirements and evolving healthcare practices with tailored, role-based training programs.
Optimize resource allocation with cost-effective, cloud-based solutions that streamline quality processes. Our system minimizes inefficiencies, reduces compliance costs, and supports scalability to meet growing operational demands.
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 |
ISO 27001 | Information Security Management Systems (for Data Security in Healthcare) |
ISO 22301 | Business Continuity Management Systems (Relevant for Healthcare Service Disruptions) |
FDA Regulations | |
21 CFR Part 11 | Electronic Records and Electronic 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 Practices (cGMP) for Pharmaceuticals |
21 CFR Part 803 | Medical Device Reporting (MDR) |
21 CFR Part 606 | Blood Banking Regulations |
GxP Guidelines | |
Good Manufacturing Practices (GMP) | Ensures Consistent Quality in Manufacturing Processes |
Good Laboratory Practices (GLP) | Establishes Standards for Non-Clinical Laboratory Studies |
EU MDR and IVDR | |
Medical Device Regulation (MDR) | Regulations for the Lifecycle of Medical Devices in the EU |
In Vitro Diagnostic Regulation (IVDR) | Standards for Diagnostic Medical Devices |
ICH Guidelines | |
ICH Q9 | Quality Risk Management |
ICH Q10 | Pharmaceutical Quality System |
ICH Q12 | Lifecycle Management |
Pharmacovigilance Standards | |
ICH E2E | Pharmacovigilance Planning |
WHO Guidelines | Safety Monitoring of Medical Products |
EMA Good Pharmacovigilance Practices (GVP) | EU Pharmacovigilance Requirements |
Global Safety and Healthcare Guidelines | |
WHO Patient Safety Standards | Global Best Practices in Patient Safety |
ISO/TS 25238 | Classification of Safety Risks for Healthcare Devices |
Digital Health and Cybersecurity Standards | |
HIPAA | Health Insurance Portability and Accountability Act (Data Privacy and Security in the US) |
ISO/IEC 27701 | Privacy Information Management Systems |
NIST Cybersecurity Framework | Protecting Sensitive Healthcare Data |
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