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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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

Keep your documents audit-ready while managing a high volume of data accurately.

Training Management

Develop employee competence while maintaining compliance. Streamline the training process with learning rules and training groups, automate task assignments, reminders, and more.

Change Management

Streamline change control processes from change request submission to final approval and successful implementation.

Design Control

Master your medical device design controls to increase market access, mitigate risk, and pass audits effortlessly.

Deviation Management

Enhance investigation, documentation, and resolution of deviations through a streamlined deviation management process.

Nonconformance Management

Simplify nonconformance processes to efficiently record, track, resolve nonconformances, and drive continuous improvement.

CAPA Management

Enhance your corrective and preventive actions to enforce continuous improvement and resolve issues as they arise.

Complaint Management

Streamline your complaint management workflow and turn complaints into product improvement opportunities and increase customer satisfaction.

Audit Management

Reduce the time and effort needed to pass audits successfully by streamlining audit-related activities.

Risk Management

Consolidate and organize risk management documentation throughout all quality processes.

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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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“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.”

Henrik Poulsen

CTO, LiNA Medical

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“Our main concern was that it would take too long and require a lot of internal resources to digitize our QMS and DHF. However, we were up and running after about one month, which was much faster than expected.”