From an auditor’s perspective: pros & cons of eQMS

Written by Dietmar Schaffarczyk

Dietmar Schaffarczyk is a Dipl. Lead Auditor for ISO 13485 QMS in the context of healthcare products (Medical Devices, In-Vitro-Diagnostics, Combination-Products and Software as Medical Device) as well as University Lecturer at ETH Zürich.

17 Jul, 2023

As the healthcare industry continues to grow, it is essential to ensure quality and compliance with regulatory standards. Electronic Quality Management Systems (eQMS) are increasingly being used to manage and maintain quality processes in organizations. This article provides an overview of different suppliers for eQMS solutions and their products, discusses the pros and cons of eQMS, and reflects on EU regulations, software validation, and frequent misconceptions by startups.
Medical Device Regulation (MDR) as well as the In Vitro Diagnostic Regulation (IVDR) require medical device manufacturers to implement a robust QMS to ensure not only compliance with regulatory requirements but also a consistent quality. That means, every time a specific process is performed, whether it is e.g., risk management, qualification of suppliers, or post-market-surveillance, the same information, methods, skills, and control measures are used and applied as set in the corresponding Standard Operation Procedure (SOP). With its SOPs and work instructions covering each process, a QMS is a company’s most extensive documentation. No wonder that lean eQMS solutions are increasingly used.

eQMS solutions offer various advantages

  • Standardization of processes | eQMS may help standardize processes and thereby ensure consistency across the organization.
  • Compliance with regulations | eQMS may help organizations comply with regulatory requirements such as FDA or MDR/IVDR regulations.
  • Improved visibility and transparency | eQMS offer improved visibility and transparency into processes, allowing organizations to identify, address and follow-up issues quickly.
  • Streamlined workflows | eQMS help streamline workflows, reducing the time and effort required to complete tasks.
  • Increased efficiency | eQMS can help organizations improve efficiency by reducing errors and rework.


Everything has its downside

  • Missing content | Some eQMS lack content specific to certain regulatory requirements or processes.
  • Overwhelming content | On the other hand, some eQMS have too much content, making it difficult for users to find what they need.
  • Lack of customization | Many users do not customize their eQMS to their specific needs, leading to failure during certification.
  • False impression of completeness | eQMS can lead to a false impression of completeness and valid content, but they do not replace human expertise when it comes to content verification.
  • Complex user interface | Some eQMS have a complex user interface, making it difficult for users to navigate the platform.
  • High implementation cost | eQMS can be costly to implement and/or maintain and grow, requiring significant investment in software and license fees.
  • Problem of software, server, and supplier validation | An organization must ensure that their eQMS system is validated to their specific needs before use to avoid non-compliance and potential fines.
eQMS suppliers and their products*

ColabON claims that ColabON can be used to manage QMS, to interprete standards, to generate generic product requirements.

Confinis developed together with an IT partner an eQMS based on the software platforms Jira and Confluence.

MasterControl is a leading supplier of eQMS and accompanying software solutions. The platform offers features such as document control, audit management, CAPA management, and change control.

OpenRegulatory Formwork is a – in the beginning – free software solution for regulatory work.

Qualio Services provides an All-in-One QMS with Documents, Training, CAPAs, claimed FDA and ISO Compliance, Reporting.

QUMAS is another major supplier of eQMS and accompanying software solutions. The platform offers features such as document control, change control, audit management, and training management.

SoftComply provides an QMS packaged as an app on Confluence and claimes with FDA and MDR regulations.

Sparta Systems provides a range of eQMS solutions that include TrackWise, Stratas, and Sparta Cloud. The platform offers features such as document control, deviation management, change control, and CAPA management.

* non-complete list; in alphabetical order

Starting with “Content First”

It is often seen that Startups misunderstand eQMS as a plug and play solution. The reality is that those systems require significant investment, customization, and ongoing maintenance. Organizations must carefully evaluate their eQMS system’s requirements and capabilities to ensure that they are fully committed to maintaining the system before investing in it. As a startup it can be more effective to start with “content-first”, customized by using Word and Excel.

Here are five reasons for the content-first approach:

1. Understanding the Process

Starting with customized content first using office applications allows a company to better understand their processes and the specific quality management needs of their business. By analyzing and documenting their processes manually, companies can identify areas for improvement, streamline their processes, and ensure that their QMS is tailored to their specific requirements.

2. Cost-Effective

Implementing an electronic QMS system can be expensive, especially for a startup or spinoff. Often the costs are hidden in additional license fees from a certain number of users or in the validation costs. Starting with a paper-based system can be a cost-effective way to establish a QMS without significant initial investments.

3. Flexibility

With a “content-first” approach, a company has the best flexibility to modify and customize their QMS as needed. This approach allows a company to adapt their system to changes in their business environment or regulatory requirements easily, before – maybe – transferring the approved content to an eQMS in a later stage.

4. Ease of Use

For small companies, an office-based system may be easier to use and maintain than some electronic QMS.

5. Compliance

Finally, the “content-first” approach will help a company ensure compliance with regulatory requirements. By creating standard operating procedures and document control procedures, the company can ensure that their QMS meets regulatory standards – without the additional BUT mandatory (a) validation of the eQMS framework and the (b) qualification and re-qualification of the eQMS supplier as critical supplier related to medtech product development.

While this “content-first” approach allows organizations to develop a better understanding of their processes and requirements, it can lead to a lack of standardization and inefficiencies in the long run. This approach rather serves to set up a company-specific QMS in a resource-saving way, which contents are later transferred to an eQMS.
So, what to conclude out of an auditor’s perspective? Since QMS are not only critical in the healthcare industry but should also be set up in a company specific manner, a startup should carefully evaluate the pros and cons of different QMS and eQMS solutions considering their individual needs. Starting with CONTENT-FIRST can be a beneficial approach. It allows for greater understanding, cost-effectiveness, flexibility, ease of use, and compliance.

Did you now? That’s why we rely on this approach in our 4C Services when it comes to supporting you with your documentation – both QMS and Technical Documentation. Because that truly enables you and trains you in Regulatory Thinking®.

This expert opinion is based on the experience of Univ.-Doz. (ETH) Dietmar Schaffarczyk with different (e)QMS systems and frameworks during his work as certification auditor for quality management systems.


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