QMS Software for Pharma & BioTech Industries

Optimize workflows and reduce human error with automated quality management processes.

Integrate data across other quality processes

With the SimplerQMS software solution, you can easily integrate quality management processes with audits, risk management, suppliers, training, post-market surveillance, and other processes in your pharmaceutical or biotech organization.

Easily upload and hyperlink any document, record, file, and email to quality events, as evidence. With SimplerQMS, you can automate data collection, routing, notifications, follow-ups, approvals, and escalation of activities.

QMS Integrated Processes
Centralized Data Storage

Store everything in a centralized, cloud storage

Stop wasting looking for the missing document, chasing signatures, and manual circulation of documents.

Centralized, cloud-based storage allows you to quickly access your documentation. This means that with the SimplerQMS you can sign and send any document with Electronic Signatures through an automated workflow from practically anywhere in the world, at any time.

Stay compliant and ensure audit readiness

SimplerQMS is ISO 13485:2016 certified and offers a ready-to-use QMS software solution for the pharmaceutical and biotech industries that complies with cGMP, GAMP5, GxP, ISO, and others. It also includes built-it FDA 21 CFR Part 11 compliant electronic signatures, time-stamped audit trails, and reporting capabilities.

Additionally, we are ready to participate whenever your organization is audited or inspected – and SimplerQMS is also, always open for audits. This means will help you get through your audits seamlessly.

Pharmaceutical Regulatory Compliance
Life Science Validation Requirements

Save time on QMS software validation activities

SimplerQMS software solution is pre-validated, it fulfills the computer system validation requirement of the GxP guidelines, FDA 21 CFR Part 11, and ISO 13485:2016.

This means that you don’t have to spend time and money on system validation processes.

100% transparent pricing

With SimplerQMS you get everything for one subscription price, depending on the number of licenses.

This means there are NO implementation fees, extra charges for hosting, system validation, user training, ongoing support, or additional modules. It’s that simple.

SimplerQMS Pricing Illustration
Customer Support and Guidance

Take advantage of an ongoing support

We provide ongoing support by email, phone, and video calls, which is also included in the subscription price.

We take pride in offering high-quality and timely support to our clients and our goal is that you and your colleagues can work in SimplerQMS with as few interruptions as possible.

Trusted QMS solution for pharma & biotech firms

SimplerQMS uses the M-Files Document Management platform as a core of its system. M-Files technology platform serves over 5,000 customers across 100 countries. It is well developed and tested to reach the highest levels of reliability and efficiency.

SimplerQMS uses the highly secure Microsoft Azure Cloud Storage solution. This means that your documents will be stored in the cloud. Therefore, you do not need to invest in highly specialized competencies and expensive server hosting hardware.

Trusted and Secure Platform
Compliance With Pharmaceutical Regulations Standards

regulatory compliance

We take full regulatory responsibility for your QMS software

We ensure compliance according to the requirements of the following standards, regulations, and guidelines in the pharmaceutical and biotech industries.

regulatory compliance

Compliant digital solution providers

Our technology platform and cloud storage providers, M-Files and Microsoft Azure Cloud, are certified according to the following standards:

  • ISO 9001:2015
  • ISO 27001:2013
  • ISO 27018:2014
Life Science ISO Compliance


The SimplerQMS modules cover all your processes

No matter if your pharmaceutical or biotech organization is a start-up or a later-stage company, our integrated modules cover your needs. All modules are included in the SimplerQMS subscription.

Training Management Module Icon

Training Management

Save time with automated training activities, learning overview, reminders, and generation of training certificates.

CAPA Management Icon

CAPA Management

Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.

Complaint Management Module Icon

Complaint Management

Reduce the associated risks and resolve issues quickly by optimizing complaint management processes.

Change Management Module Icon

Change Management

Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.

Audit Management Icon

Audit Management

Automate your audit-related activities and ensure better audit preparedness.

Document Management Module Icon

Document Control

Automate and standardize your document control activities with ease.

Risk Management Icon

Risk Management

Consolidate risk and handle your risk management file in a well-organized and structured manner.

Supplier Management Module Icon

Supplier Management

Simplify supplier-related activities and handle your supplier documentation following the standards.

Featured Case Study

From Paper to Digital Workflows in 1 Month

Reapplix is a regenerative medicine company that helps people who suffer from hard to heal diabetic foot ulcers, which may result in amputation. The company is in the initial commercialization phase in the US and selected European markets and was looking for a way to get rid of inefficient paper-based documentation and processes.

Trusted by companies around the world

Ready to learn more?

To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.

SimplerQMS Demo Interface