FDA 21 CFR Part 11 Compliant QMS Software

FDA 21 CFR Part 11 compliant QMS software designed for life science organizations. Ensure compliance with FDA 21 CFR Part 11 requirements for electronic records and signatures while streamlining your quality processes.

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Join Over 5,000+ Quality Professionals Who Trust SimplerQMS

Comprehensive QMS Software for Life Science Industries

SimplerQMS provides a fully validated, cloud-based eQMS compliant with FDA 21 CFR Part 11. The platform ensures secure electronic records and signatures, complete audit trails, and robust user access controls. Beyond Part 11 compliance software, SimplerQMS also supports compliance with EU GMP Annex 11, GxP, ICH Q10, ISO 13485, ISO 9001, and other relevant requirements.

SimplerQMS unifies all QMS modules, including Document Control, Change Management, Training, Nonconformance Management, CAPA, Complaints, Audit Management, Risk Management, Supplier Management, and Equipment Management, within a single validated system.

SimplerQMS is fully validated in accordance with ISPE GAMP 5 guidelines, helping life science organizations achieve and maintain continuous compliance and audit readiness from day one.

Life Science QMS Software Modules

Explore the key QMS modules included in SimplerQMS.

Document Control

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

Training Management

Automate and manage training activities to support staff competence and maintain controlled training records.

Change Management

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

Deviation Management

Record, investigate, and document deviations to support timely resolution and compliance.

CAPA Management

Identify and address quality issues, implement corrective and preventive actions, and reduce recurrence risk.

Complaint Management

Log and manage customer complaints to support investigation, traceability, and reporting requirements.

OOS Management

Capture, investigate, and document out-of-specification results to support timely resolution and compliance.

Audit Management

Plan, conduct, and document audits to support inspection readiness and timely follow-up.

Risk Management

Identify, assess, and document risks to support mitigation and protect quality and compliance.

Equipment Management

Track and maintain equipment to support accuracy, availability, and compliance.

View all modules

Streamline Processes and Improve Efficiency

Automate repetitive tasks, minimize bottlenecks, and visualize workflows.

SimplerQMS integrates seamlessly into daily processes, helping your team save time and work more effectively.

Ongoing Task Completion

Related features

Microsoft Office Integration

Work with Microsoft Office suite applications, such as Word, Excel, and PowerPoint.

Visual Workflows

Visualize workflows for a complete overview of document processing and related steps.

Actions, Tasks, Reminders

Assign, track, and manage tasks across documents and processes.

Securely store and share documents in one central repository.

Project Management

Oversee projects and link them to related documents and processes.

Group Assignments

Easily assign review and approval tasks to individuals or groups.

Ensure Compliance and Control

Ensure regulatory compliance and operational oversight with predefined workflows.

SimplerQMS supports compliance with the relevant life science requirements, such as FDA 21 CFR Part 11, EU GMP Annex 11, GxP, ICH Q10, ISO 13485, ISO 9001 requirements, and more.

Computer and Electronic Signature

Related features

Life Science QMS Template

Use best practice QMS templates for manuals, procedures, forms, and instructions.

User Access Management

Ensure secure access for both internal and external users.

Electronic Signatures

Enable paperless, compliant signing to ensure authenticity and integrity.

System Audit Trail

Keep a complete, time-stamped audit trail of all system changes.

Controlled Printing

Control and monitor document printing to ensure compliance.

Reg. Standard Management

Track relevant regulatory requirements and link them to your documents and processes.

Simplify Reporting and Data Management

Utilize quality KPI reporting and information management tools to make informed decisions.

SimplerQMS provides quality KPI reporting, streamlined content search, and data export, enabling a data-driven approach to quality management.

Reporting - Bar Chart

Related features

Quality KPIs

Track key quality KPIs and metrics with reporting for data-driven decisions.

Content Search & Indexing

Find information instantly with a Google-like search across all content.

Export Data & Content

Export documents and system metadata easily for analysis or integration with external tools.

Adapt Workflows to Support Specific Processes

Configure fields, templates, and forms to match your processes.

Enable integrations and API connections to ensure smooth data flow across systems.

Workflow Configuration

Related features

Custom Fields

Tailor data capture with configurable fields like dropdowns, text, numbers, and dates.

Template Management

Create and manage forms and templates for consistent and compliant collection of information.

API / System Integrations

Connect your QMS with external systems to enable seamless data flow.

Service Components by SimplerQMS

All service components are included at no extra cost.

Unlimited Online Training

Access unlimited training sessions to build user knowledge, ensure confidence, and maximize system adoption.

System Implementation

Our experts guide you through the implementation for a fast, efficient transition with minimal disruption.

Document Migration

We help migrate your existing documents securely, preserving data integrity and saving valuable time.

Audit Assistance

Get dedicated support for audits, covering validation, data security, and system backup needs.

System Validation

Delivered fully validated to ISPE GAMP 5 and kept in a validated state with every update.

Cloud Hosting

Enjoy secure, reliable cloud access to your eQMS anytime, anywhere – without heavy IT demands.

QMS Software With Transparent Pricing for Budget Control

SimplerQMS includes all QMS modules, system validation, implementation, cloud hosting, training, and support in a single yearly license.

Pricing depends only on the number and type of licenses.

No hidden costs – everything you need is covered.

All QMS Modules

System Validation

Document Migration

Cloud Hosting

Implementation

User Training

Unlimited Support

And much more…

What Our Customers Achieved

Improved Audit Readiness

“We put SimplerQMS on the big screen during audits to be transparent and show that we’re in control of our QMS processes.”

Reduced 50% Onboarding Time

“In four weeks, you can have a very good read-and-understood process with a system that is easy to set up and user-friendly.”

Control of Complex Processes

“A big advantage is getting a complex, company-wide change process under control – everyone knows what to do and when.”

What Customers in the Life Science Industries Say

“Spending most of my day using SimplerQMS, I would say I am very pleased with the ease of use.”

Dorthe W.

QA/RA Manager, Cortex Technology

“SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS, and is easy to use.”

Subba S.

Chief Technology Officer, CollaMedix

“Easy to work with. Intuitive. Rather easy to setup. Very good customer support. Good quality to price ratio.”

Jean Claude M.

Head of Hardware and Software Development, hemotune

Dedicated Support Always at Your Side

Online Training Sessions

Comprehensive training to ensure your team uses the QMS effectively.

24/7 Customer Support

Expert assistance is available anytime for quick issue resolution.

Knowledge Base

Step-by-step guides and articles for easy self-learning.

See SimplerQMS in Action

Discover how our FDA 21 CFR Part 11 compliant QMS software can help your company streamline quality management and stay compliant.