Company NewsOctober 4, 2019

Make your quality digital

What is undocumented, has not been done. This certainly applies to the…
Avatar Daniela Jansen

What is undocumented, has not been done. This certainly applies to the discipline of regulatory compliance. Nevertheless, organizations still miss opportunities if they fixate on documents and hereby lose sight of the data – and maybe of quality. How do they take the step towards ‘data-based quality’?

The disciplines of quality management and documentation are intrinsically connected. A company is quickly faced with thousands of documents in which, for instance, Standard Operating Procedures (SOPs), work instructions and policies are defined and outcomes and test results are recorded. Documenting audits and ‘corrective and preventive actions’ (CAPAs) means the stream of documents only further increases.

These documents are necessary to demonstrate the quality of products, processes and services and compliance with laws and legislations. But, a lot more is possible with the data from quality systems. Just think of the advantage of being able analyse quality data, so that trends become visible and threatening issues can be quickly identified. A company can then intervene before matters are noticed by customers and the cause of the threatening problem can also be retrieved from the data. If the data is reliable enough, enterprises can even leverage this for true knowledge-based decision-making.


  1. Invest in technology

The step towards a data-centric approach means imposing higher standards on the quality of data. This data should be of good quality, reliable, and should be in context in order to be meaningful. And should remain this way throughout a product’s entire lifecycle. This requires integration of processes and systems with can be achieved by implementing a virtual experience platform, such as Dassault Systèmes’ 3DEXPERIENCE platform. A system like this helps collect and validate data in real-time, makes it centrally available and provides capabilities beyond digital continuity – true enterprise wide digitalization.

  1. Create a quality culture

Digitalization of a quality system is only one part of the required change, it also requires that everyone feels responsible for quality. This is not the responsibility of just one single department, but affects the whole enterprise. Documentation is important but not enough. The understanding of the impact of any activities on quality and the relevance of data quality and integrity must be part of the mind-set of every employee.

Digital quality is in brief much more than having the documents available in an electronic format. It concerns digitalizing and connecting both the processes and the data, which should be reliable and of high quality. Ideally they are supported by advanced enterprise-wide technology and a company-wide culture of quality.  With this approach, quality as well as regulatory compliance are easily met. And organizations have a good foundation on which to base sound decision-making.

For more information about Dassault Systèmes work in the Life Science industry please see here.

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