Category: News & Blog

News and Events for industries such as medical device manufacture

Top 5 Software Tool Validation Challenges

Facing validation of (non-product) software applications?   This article is for you! Our clients have faced push back from the FDA during submissions, during audits and while attempting certification for the CE label – these...


From SOUP to Nutz – Software of Unknown Provenance

How I Learned to Stop Worrying and Love Software of Unknown Provenance Because Software of Unknown Provenance, or SOUP, has a variety of definitions or explanations, depending upon the source, we’ve laid out this...