QMS Software for Contract Research / Manufacturing Organizations (CRO / CMO)

Streamline operations and maintain regulatory compliance with purpose-built quality management software for Contract Research / Manufacturing Organizations (CRO / CMO).

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Ensure Regulatory Compliance in Your Contract Organization

Contract manufacturers, clinical research organizations, and testing laboratories (CxOs) must comply with the same regulatory requirements as their clients in the pharmaceutical, biotechnology, medical device, and other life science industries.

CxOs must maintain compliance with relevant standards, regulations, and regulatory guidelines in Life Sciences depending on the clients they serve such as GxP, FDA 21 CFR Part 11, 210, 211, and 820, ISO 13485:2016, ICH Q10, EU MDR and IVDR, EU GMP Annex 11, ISO 9001:2015, and others.

Compliance with these requirements can be achieved easier and faster with a purposefully built QMS software solution for Contract Organizations from SimplerQMS.

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One Platform That Integrates All Quality Processes

With the SimplerQMS software solution, you can streamline regulatory compliance and typical CRO / CMO quality control processes by automating repetitive documentation activities.

Integrate all your quality assurance and control processes, store data in centralized, cloud storage, and manage risks, training, audits, suppliers, and other processes with ease.

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Work More Efficiently in Microsoft Office Environment

SimplerQMS integrates with native Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint, so you and your team can work with the tools you’re already familiar with.


Simply work on your documents within Microsoft Office applications and once the work is done, save them with one click in SimplerQMS Cloud. No manual download and upload of documents are required.

Streamline Your Document Control Processes

Automate document routing, follow-ups, tracking, escalation, review, approval, and other document-based processes.

With features like time-stamped audit trails and FDA 21 CFR Part 11 compliant electronic signatures built into the SimplerQMS solution, you can be confident that all documents are processed efficiently and follow the applicable regulatory requirements.

Learn more about document control
SOP Being Signed With Electronic Signature in SimplerQMS
Validation Applicability Matrix

Forget About Time-Consuming Validation Activities

Software validation is a requirement for CROs and CMOs as well as other life science organizations that store and manage quality records electronically.

SimplerQMS provides a fully validated solution and performs monthly re-validation of the system, in compliance with FDA 21 CFR Part 11, ISO 13485:2016, and GxP guidelines. This means that your organization won’t have to spend time on system validation processes.

What Validation Documentation Evidence Does SimplerQMS Provide?

  • Validation Procedure
  • Validation Plan
  • Validation Report
  • IQ, OQ and PQ Documentation

Manage Nonconformance More Easily

The SimplerQMS nonconformance management solution facilitates the process of identifying, evaluating, analyzing, and managing non-conformances.

Access a single source of truth where all processes are connected from non-conformances and other quality events to training, audit findings, and more

Learn about non-conformance management
Non-Conformance Trending Report in SimplerQMS
Customer Complaints Trending Report in SimplerQMS

Resolve Customer Complaints Quickly and Effectively

As a CRO / CMO, it’s of the highest importance for you to meet the requirements of your main customers without delays and quickly resolve any complaints.

SimplerQMS provides robust customer complaint-handling capabilities which allow you to track, manage, analyze and resolve customer complaints in a timely and effective manner.

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Automate and Gain Traceability of Your CAPA Processes

The SimplerQMS CAPA management software solution integrates with different QMS sub-systems and provides a closed-loop CAPA process.

Save time with automated CAPA workflows and pre-configured CAPA forms, and avoid any errors in manual data entry or process execution.

Learn more about CAPA management
Documents Related to CAPA in SimplerQMS

Manage Changes More Effectively

The change control module by SimplerQMS allows you to automatically track changes, collect data, and send changes through an approval process.

Automated follow-ups, notifications, and escalation activities help you quicker finalize changes to SOPs in your system.

Explore our change control module

Expedite Employee Training Management Processes

With continuous changes taking place daily, you must ensure that employee training in your contract organization is well-documented and in compliance with regulatory requirements.

SimplerQMS training management module streamlines training processes by automating the assignment of training activities, reminders, generation of training certificates, and more.

Explore training management features

All-in-One QMS Software for Life Sciences

View all modules
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Document Control

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

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Training Management

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

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Change Management

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

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Deviation Management

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

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CAPA Management

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

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Complaint Management

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

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OOS Management

Streamline your out-of-specification (OOS) laboratory result investigations by ensuring consistent OOS result intake, root cause identification, follow-ups, and resolutions.

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Audit Management

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

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Risk Management

Consolidate and organize risk management documentation throughout all quality processes.

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Equipment Management

Simplify the equipment registration, calibration, and maintenance tasks with straightforward workflows.

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Frequently Asked Questions

As a Contract Research / Manufacturing Organization (CRO / CMO), you are responsible for ensuring that the services you provide meet customer expectations and regulatory requirements. An effective quality management system (QMS) is essential to help you manage your processes and ensure compliance. By implementing a QMS, you can streamline your operations, improve communication and collaboration between different departments, and ultimately provide better quality services to your customers.

QMS software solutions offer many benefits for Contract Organizations, including streamlined operations and improved efficiencies, reduced paper documentation and associated costs, increased visibility into quality data for better decision making, improved compliance with regulatory requirements, and enhanced communication between sites, sponsors, and staff.

Yes, SimplerQMS provides a fully validated software solution. It is validated according to ISPE GAMP5 and undergoes revalidation for each new version or standard update.

We do all the software validation for you – there are no additional expenses, resources, or time commitments to software validation on your part.

SimplerQMS complies with requirements regarding the validation of systems used for QMS such as 21 CFR Part 11, and 820, EU GMP Annex 11, and ISO 13485:2016.

Furthermore, we provide extensive validation evidence for use during audits and inspections, including the validation plan, procedures, and reports, as well as IQ, OQ, and PQ documentation.

SimplerQMS provides an all-in-one QMS software solution that includes all modules, implementation, training, ongoing support, validation, hosting, and more. With SimplerQMS, you pay one price that covers everything – there are no other subscription fees.

The exact price of the solution differs depending on how many people will use it, and the license types required. Therefore we recommend you book a tailored demo and talk to our experts to request a pricing quote for the needs of your organization.

Depending on whether you already have a quality management system (QMS), and the number of documents, implementation time may be shorter or longer. Our experience shows that the average implementation time for a new QMS is between five and six weeks. However, we have seen clients go live in as little as three weeks.


Our team of experts will work with you every step of the way to ensure a smooth and successful transition to our software.

What Customers Achieve With SimplerQMS

Utilize Proven Technology

SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.

Pass audit more easily

Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.

Gain high level of traceability

Gain cross-functional visibility and trace back to the root cause of each nonconformance.

“It’s very flexible, smooth, and easy to use. Documents no longer get lost and the whole history of all products is accessible for anyone at any time.”

Christian Schärfe Thomsen

Project Manager, Cortex

What Customers in Pharmaceutical and Biotechnology Industries Say About SimplerQMS

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“SimplerQMS gave us excellent pricing and customer support to help us understand how to use their system and set up our QMS, which is easy to use. We can continue to use Microsoft Office for our documents. They have templates for all of the QMS sections that we could choose to use as the basis.”

Subba S.

CTO, Medical Devices

“I have been using SimplerQMS for several years and have consistently been impressed with its flexibility and range of features. These features have met all my needs in every aspect, facilitating a smoother and more efficient management of quality documents and processes.”

René M.

CEO, Medical Devices

“SimplerQMS comes with plenty of features, which help a lot in keeping the daily work inside the eQMS. My team and I find the system user-friendly and simple to use. Whenever challenges and issues arise, the support team from SimplerQMS immediately takes action to find a solution and solve the problems.”

Vlad C.

Quality Manager, Medical Devices

See SimplerQMS in Action

To see SimplerQMS in action and learn how you can make the most of it, request a personalized demo presentation.

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