Category: News & Blog

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...


Why FDA Compliance (knowledge) Matters

Is your software engineering vendor helping or hurting you? When you are reviewing the myriad software engineering vendors out there, as part of your due diligence – for your own sanity, make sure you...