SimplerQMS

Pharmaceutical and Biotechnology

Manage GMP-compliant documentation, batch records, training, and CAPA in one validated quality management software. SimplerQMS supports compliance with FDA 21 CFR Parts 210–211, ICH Q10, and related GMP requirements. Explore QMS Software for Pharma & Biotech

Medical Device

Manage design control, risk management, and post-market activities under one integrated QMS software. SimplerQMS supports compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR/IVD, and other requirements. Explore QMS Software for Medical Devices

Clinical and Medical Laboratories

Manage document control, equipment records, training, and other quality processes in one QMS software. SimplerQMS supports compliance with ISO 15189, CLIA and related requirements applicable to clinical and medical laboratories. Explore QMS Software for Laboratories

Contract Research, Development, and Manufacturing

Manage quality documentation, audits, protocols, and other quality processes in one centralized quality management solution. SimplerQMS supports compliance with GxP requirements and sponsor expectations across outsourced research and manufacturing activities. Explore QMS Software for CROs and CDMOs

Native Microsoft 365 and Copilot AI Integration

Integrate seamlessly with Microsoft 365 and Microsoft Copilot (AI Assistant) to create, review, and collaborate on documents directly in Word, Excel, and PowerPoint.

Electronic Signatures and Complete Audit Trails

Use built-in e-signatures and time-stamped audit logs compliant with FDA 21 CFR Part 11 and EU GMP Annex 11 to ensure data integrity and full traceability. Learn about electronic signatures

Automated Workflows and Linked Records

Automate reviews, approvals, and routing while linking related records to maintain traceability across all quality processes.

Centralized Dashboards and Reporting

Visualize key metrics and KPIs through real-time dashboards that drive data-based decisions and continuous improvement. Learn about analytics and reporting