adesso Blog

The long-awaited draft guidance for Computer Software Assurance for Production and Quality System Software was published last September. Being a draft state, it’s open to comments and discussion. The non-binding final guidance will reflect FDA’s current thinking of the topic. But what can we learn from this draft guidance already?

For many multi-brand corporations, the problem of a fragmented digital ecosystem is one that develops over time. Not only does the number of digital touchpoints and end devices constantly increase, but the number of technical and regulatory requirements rises, too. In my blog post, I will show you how companies can counter this problem and this challenge with the help of an example from a project.