The QMS Software Built by Life Science Experts

SimplerQMS is the QMS software for life science companies – helping you boost productivity by up to 50% and reduce costs.

QMS Software Built for Life Science Industries

SimplerQMS is designed for regulated life science sectors, including pharma, biotech, medical devices, laboratories, and CROs/CMOs.

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

Guiding Life Science Companies Toward Compliance and Quality Excellence

SimplerQMS helps life science companies simplify compliance and strengthen quality through a fully validated QMS software and expert, hands-on support.

Trusted Partnership

• End-to-end support, from implementation and training to audits.

Expert Guidance

• Support from specialists who understand life science processes.

Purpose-Built Platform

• Designed for compliance and efficiency, with full traceability.

Comprehensive Services

• Everything you need: implementation, validation, training, and 24/7 support.

Human Approach

• Real experts committed to your compliance and operational success.

QMS Software Supporting FDA, ISO, and GxP Compliance

SimplerQMS helps life science companies ensure compliance with FDA, ISO, EU, GxP, and other regulatory requirements through a fully validated QMS software.

Compliance Certifications

• ISO 13485:2016
• ISO/IEC 27001:2022
• FDA 21 CFR Part 11
• FDA 21 CFR Part 820
• FDA 21 CFR Part 211
• CLIA
• EU MDR
• UK MDR

Streamline Quality Processes with QMS Software Modules in SimplerQMS

SimplerQMS QMS modules streamline quality processes while strengthening compliance and traceability.

Quality Event Management

• Centralize and control documents and records with version control, e-signatures, and audit trails.

Document Control

• Centralize and control documents and records with version control, e-signatures, and audit trails.

Change Management

• Streamline change control processes from request submission through review, approval, and implementation.

Explore Core Features of Our Cloud-Based Quality Management Platform

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.

Centralized Dashboards and Reporting

• Visualize key metrics and KPIs through real-time dashboards that drive data-based decisions and continuous improvement.

How to Choose the Best QMS Software for Life Science Companies?

Define Regulatory Requirements

• The first step in selecting the right QMS software is to clearly define your organization’s regulatory, quality, and business requirements.

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