Quality Management

QMS Software Validation

Validation of the implementation of your software

If software is used in Quality Management System processes, the application of this software must be validated.

QMS Software Validation according to EN ISO 13485

Since the 2016 iteration of EN ISO 13485, Chapter 4 has included the requirement for validation of software used in quality management systems. Furthermore, the requirement for validation of software used in the manufacturing has existed since the 2003 version of EN ISO 13485.
Validation is, in simple terms, checking whether goals can or cannot be achieved. These goals are found in the purpose of the software. Here, like the validation of Medical Devices, the creation of a purpose statement helps. The questions "who", "how", "what", "when" help to create clarity.

If you have determined the intended purpose, you can also estimate the risk, and if this is low, you can reduce the extent of the validation. Unfortunately, to waive such extensive validation is only possible, if the result of the software can and always will be checked by subsequent monitoring or measurement!

The verification and validation of software, which is part of a Medical Device or stand-alone software, takes place within the development process and should not be confused with the validation of QMS Software!

FAQ for the validation of QMS Software - You probably are familiar with this issue as well

Have you ever asked yourself these questions?

  • What should I validate if my Medical Device does not contain software?
  • Do I also have to validate my operating system or ERP software?
  • How extensive must the validation be and what do I have to test?

Our experts know how to validate QMS Software so that software errors do not affect the quality or safety of your Medical Devices or the efficiency of your Quality Management System.

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval and registration of Medical Devices. I will answer your questions regarding a QMS Software Validation and put together a team for your project upon request.

Our forms of contract Contact +49 451 808 503 60

qtec as your partner

Our team will support you in the development and implementation of a procedure required by EN ISO 13485 or take over the actual validation of your QMS software.

We can provide many supportive services, for example: provide planning, arrange requirements, and test cases with you, carry out the validation and give practical tips for the maintenance phase.

The ERP software must be considered in the same way as the software for document management or in-house developed software.

We are happy to show you how to save effort with a risk-based approach, while still having controlled and capable processes and meeting regulatory requirements.