SimplerQMS is a fully validated electronic Quality Management System (eQMS) designed specifically for life sciences companies. It helps businesses in pharmaceuticals, biotechnology, medical devices, and other regulated industries to streamline their quality processes and ensure compliance with FDA, EU MDR, ISO 13485, and GxP requirements.
The platform is built on Microsoft Cloud and offers ready-to-use modules for document control, training, CAPA, non-conformance, audits, and more. SimplerQMS helps organizations transition from paper-based or semi-digital quality systems to a fully digital, compliant, and efficient environment.
With built-in validation, automated workflows, and audit readiness, SimplerQMS enables teams to maintain control over quality management processes while saving time and reducing compliance risk.
Features
SimplerQMS offers a comprehensive suite of features to support end-to-end quality and compliance management in regulated industries.
Fully Validated eQMS
The platform is delivered with full software validation according to FDA 21 CFR Part 11 and EU Annex 11. This removes the burden of system validation from internal teams.
Document Control
SimplerQMS includes robust document management with version control, electronic signatures, change history, and automated approval workflows. This ensures compliance with ISO 13485 and FDA documentation standards.
Training Management
Organizations can manage employee training records, assign training tasks, track completion, and link training to controlled documents or SOPs.
CAPA Management
Corrective and preventive action (CAPA) workflows help identify root causes, implement corrective actions, and monitor effectiveness.
Non-Conformance Handling
The system allows teams to record non-conformances, investigate issues, and initiate follow-up actions, helping prevent recurrence and ensure quality standards.
Audit Management
SimplerQMS supports planning, conducting, and documenting internal and external audits. Findings can be linked directly to CAPAs and follow-up tasks.
Supplier Management
Teams can manage supplier qualifications, documentation, and audits in a centralized module, supporting supply chain compliance.
Risk Management
Built-in risk assessment tools support ISO 14971 compliance for medical device manufacturers, enabling risk-based decision-making throughout the product lifecycle.
Complaints Management
SimplerQMS allows tracking of customer complaints, investigation, and closure, with links to CAPA processes where necessary.
Electronic Signatures
The platform supports compliant electronic signatures in accordance with FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
Automated Workflows
Quality processes are streamlined through configurable workflows with task assignment, deadlines, and escalation paths.
Microsoft Azure Cloud Hosting
SimplerQMS is hosted on Microsoft Azure, ensuring high availability, performance, and data security with enterprise-grade infrastructure.
How It Works
SimplerQMS operates as a cloud-based eQMS, allowing life sciences companies to manage their entire quality system in a centralized, validated, and secure environment. Once the system is implemented, users are onboarded and trained by SimplerQMS experts.
The system comes with pre-configured modules that meet life sciences regulatory standards, meaning companies can go live without lengthy configuration or validation processes. Teams can start using modules such as document control, CAPA, and training immediately.
Each process—whether it’s document approval, a CAPA investigation, or a training task—is managed through an automated workflow. Responsible users receive notifications, and actions are logged with time stamps and electronic signatures for full auditability.
SimplerQMS provides real-time dashboards and reporting tools that help quality managers monitor performance, track compliance metrics, and maintain audit readiness at all times.
Use Cases
SimplerQMS supports a variety of use cases across life sciences and other highly regulated industries.
Medical Device Manufacturers
Companies use SimplerQMS to comply with ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements, managing technical documentation, CAPA, and audits in one system.
Pharmaceutical and Biotech Firms
SimplerQMS supports GMP compliance and documentation control for drug development, manufacturing, and distribution activities.
Clinical Research Organizations (CROs)
CROs rely on SimplerQMS for managing quality records, training, and risk, helping maintain GCP compliance throughout clinical trials.
Contract Manufacturers
CDMOs use SimplerQMS to ensure client and regulatory compliance across multiple quality systems, products, and documentation sets.
Startup Life Sciences Companies
Early-stage companies use SimplerQMS to prepare for regulatory inspections, clinical trials, and product approvals without building manual systems from scratch.
Global Operations
Multinational life sciences organizations use SimplerQMS for centralized quality management across geographies while meeting region-specific compliance requirements.
Pricing
SimplerQMS uses a subscription-based pricing model tailored to company size and functional requirements.
Pricing depends on factors such as:
Number of users
Selected modules (document control, CAPA, training, audits, etc.)
Storage and data retention needs
Implementation and onboarding services
Validation and regulatory support
SimplerQMS does not publicly disclose exact pricing. Companies are encouraged to request a personalized quote or demo.
Strengths
SimplerQMS offers multiple advantages that make it ideal for life sciences organizations.
Life Sciences Focus
The platform is purpose-built for pharmaceutical, medical device, and biotech companies, ensuring deep alignment with industry regulations.
Ready-to-Use and Validated
SimplerQMS is delivered pre-configured and fully validated, helping organizations go live faster and without the need for costly internal validation.
End-to-End QMS
From document control and CAPA to supplier and audit management, the platform covers the full spectrum of quality processes.
Compliant Electronic Signatures
Fully compliant with FDA 21 CFR Part 11 and EU Annex 11, ensuring data integrity and audit readiness.
User-Friendly Interface
Designed for easy adoption by quality teams, with minimal training required and strong usability.
Scalable Cloud Infrastructure
Built on Microsoft Azure for secure, reliable, and scalable cloud deployment with minimal IT overhead.
Efficient Onboarding
SimplerQMS provides comprehensive implementation support, training, and customer service to ensure fast and successful adoption.
Drawbacks
While SimplerQMS is a powerful solution, there are some limitations depending on the organization’s needs.
Life Sciences Specialization
The platform is best suited for life sciences companies. Organizations outside these sectors may not fully benefit from its specialized features.
No Public Pricing
The absence of upfront pricing can be a barrier for smaller companies looking to compare solutions quickly.
Limited Third-Party Reviews
As a niche solution, SimplerQMS has fewer reviews on major software directories compared to broader QMS platforms.
Customization Limits
Since the platform is built around life sciences compliance, extensive customization for unrelated use cases may not be feasible or necessary.
Comparison with Other Tools
SimplerQMS is often compared to other QMS and eQMS platforms such as MasterControl, Greenlight Guru, Qualio, and Veeva Vault QMS.
MasterControl is highly comprehensive and widely used in large enterprises but can be complex and expensive for smaller teams.
Greenlight Guru is focused on medical devices and is ideal for startups but may lack broader features for pharma or biotech firms.
Qualio offers ease of use and rapid deployment, but SimplerQMS provides more pre-validation and structured workflows.
Veeva Vault QMS is enterprise-grade and scalable but may be more suited for large global pharma companies with complex needs.
SimplerQMS stands out for its balance of compliance, usability, and affordability, especially for growing life sciences companies that want a ready-to-use, validated QMS.
Customer Reviews and Testimonials
SimplerQMS shares customer testimonials and case studies from clients in medical devices, biotech, and diagnostics industries. Clients highlight the platform’s ease of use, strong compliance alignment, and responsive support.
Key benefits noted include:
Faster audit readiness
Reduced time spent on document approval and CAPA closure
High user satisfaction with the intuitive interface
Confidence in regulatory inspections due to built-in validation
Several customers report successfully transitioning from manual or semi-digital systems to SimplerQMS with minimal disruption and measurable efficiency gains.
Conclusion
SimplerQMS is a cloud-based, fully validated eQMS platform designed to meet the unique needs of life sciences companies. With modules covering all major quality management areas and full compliance with global regulatory standards, it empowers organizations to maintain a high level of quality, reduce risk, and stay inspection-ready at all times.
Whether you are launching a new medical device, scaling pharmaceutical operations, or managing complex quality workflows across regions, SimplerQMS provides a practical and powerful solution tailored to your regulatory landscape.
