Life Science Quality
Management Software

Streamline and automate quality management processes with fully validated life science QMS software.

Get all QMS modules like document control, change management, training, CAPAs, and more in one solution.

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See SimplerQMS in Action

Explore our interactive demos to see how SimplerQMS streamlines quality management for life science companies.

Comprehensive QMS Software Solution

Full Regulatory Compliance

SimplerQMS software supports compliance with Life Science requirements, such as GxP, ISO 13485:2016, FDA 21 CFR Part 210, 211, 820, ICH Q10, EU MDR and IVDR, ISO 9001:2015, and others. Hundreds of successful audits and inspections have been completed using SimplerQMS.

Don’t Spend Time on Validation

SimplerQMS is fully validated according to GAMP5 (Cat.4) in compliance with FDA 21 CFR Part 11, EU GMP Annex 11, ISO13485:2016. We share continuously updated validation evidence with each of our customers (full IQ, OQ, PQ documentation).

Microsoft Office 365 Integration

Work in Microsoft Office while editing documents in SimplerQMS Cloud. Changes are automatically saved in the audit trail to reduce errors and save time. Keep using your existing Microsoft Word and Excel forms and templates in SimplerQMS.

Unlimited Training and 24/7 Support

Our customers attest to our excellent, training and around-the-clock support at no additional cost. Choose from various options: Email, Phone, Video Calls, Support Portal, and Online Knowledgebase. No limits on hours—reach out anytime, and we’re ready to assist.

All-Inclusive QMS Software Solution

SimplerQMS provides a comprehensive QMS solution, including all QMS modules, system validation, implementation, cloud hosting, user training, and support—all within the yearly license cost. No additional fees. Everything you need is covered. It’s that simple.

Modules

SimplerQMS offers an out-of-the-box QMS software solution that includes all QMS modules for every customer.

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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.

Design Control

Control and document design activities to manage risk and meet regulatory requirements.

Deviation Management

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

Nonconformance Management

Capture and address nonconformances to correct issues and support timely resolution.

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.

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.

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QMS Software for the Life Sciences

Medical Devices

Simplify compliance with medical device requirements and enhance quality management processes.

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Pharmaceuticals and Biotech

Streamline quality workflows, enhance accuracy, and reduce risks across pharmaceutical and biotech operations.

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Clinical and Medical Laboratories

Streamline laboratory processes while ensuring precision, compliance, and operational excellence.

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Customer Case Studies

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“We got compliments from auditors during audits and afterward. The way SimplerQMS works and the way we get all the relevant information [readily available] online in a few minutes [allow auditors] to witness the way SimplerQMS works and the advantages of it.”

René Rousseau

Senior Manager of Quality Affairs, Basic Pharma

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“The buzzword for a digital quality system is effectiveness. Because by eliminating paper, you can become more optimized on your operations, especially to get a tamper-proof system in relation to all key features that the document management system requires.”

Pablo Moreno

Director of Quality, Minerva Imaging (CDMO)

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“We are moving from our current paper-based system to SimplerQMS in order to spend less time on manual processing of documentation. We chose SimplerQMS because they are ISO13485 certified and specialized in the life science industry. It was also important for us that their implementation package included system validation and that the software is user-friendly.”