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

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.

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.

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.