Comprehensive Quality Management System for pharmaceutical distributors and regulated industries. Full GDP, ISO 9001, ISO 13485, and ISO 14971 compliance with complete audit trails.
All core modules are built, tested, and production-ready with complete audit trails and regulatory compliance
Version control, approval workflows, digital acknowledgments, and secure PDF viewing
Training assignments, completion tracking, and certificate generation with QR codes
Non-conformance tracking, root cause analysis, and corrective/preventive actions
Supplier qualification, evaluation tracking, and vendor documentation
Internal/external audits, findings tracking, and external auditor portal access
ISO 14971 risk assessments with FMEA, risk matrix, and mitigation tracking
7-year retention compliance, legal holds, and destruction certificates
7-year compliant retention
Built for compliance, security, and scalability from day one
Complete data isolation with company-specific access and Row Level Security
Every action logged with timestamps, user attribution, and change details
Automated reminders for acknowledgments, training, and compliance deadlines
Secure, time-limited access for third-party auditors and certification bodies
Comprehensive dashboards and export capabilities for compliance reviews
Professional PDF certificates with QR codes and digital verification
Choose between cloud SaaS or self-hosted deployment based on your organization's regulatory and security requirements
Fully managed cloud solution with automatic updates, backups, and 24/7 availability
Deploy on your own infrastructure with Docker for complete control and data sovereignty
Keep all data within your infrastructure
Meet strict data residency requirements
Run in isolated network environments
Lower long-term costs for large teams
Designed to meet the specific compliance needs of highly regulated sectors
GDP compliance for wholesale distributors, 3PLs, and pharmaceutical logistics
ISO 13485 and ISO 14971 compliance for medical device manufacturers
ISO 9001 quality management for general and specialized manufacturing
GDP and temperature-controlled logistics compliance
GLP and GMP compliance for biotech research and production
CMO, CRO, and CDMO quality management compliance
Built to support multiple international quality and regulatory standards
QMS Zone provides the tools and framework to help you achieve compliance with these standards. Actual certification requires working with accredited certification bodies and implementing appropriate processes, procedures, and controls within your organization. Our platform supports your compliance journey but does not guarantee certification.
Every organization has unique needs. We customize pricing based on your requirements.
From 10 to 1000+ users
Single or multi-standard
Cloud or self-hosted
Ready to transform your quality management? Let's talk about your needs.
Interested in deploying QMS Zone on your own infrastructure? Get early access to our Docker deployment.
Request Self-Hosted InfoSee QMS Zone in action with a personalized demo
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