Category: News & Blog


Would your Non-Product Software PASS an FDA Audit?

Are you at Risk of Non-Compliance…for Non-Product Software Tool Validation? How do you know if you’re fully compliant? What we’ve observed. Because we provide QMS Support to Biotech, Pharma & Medical Device companies, we’ve...


What is your Top 10 List for Passing an FDA Audit?

Is your team preparing for an audit…possibly caused by excessive CAPA’s? I know (we) engineering types don’t always appreciate guidance the quality folks share with us – particularly regarding compliance best practices – but...