Zero Findings in a Regulated Industry, Possible?
Not too many years ago, I would have thought this next to impossible. However, with the right quality team and a robust QMS, it is possible. This requires a dedicated team with the mind set of always being 'Audit Ready'. This is more that just a catch phrase. Recently, a corrective action follow up audt turned into a QMS audit that resulted in zero findings. This can happen for you with the right QMS in place and the right people on the team. And yes, it is even possible to come out on the other end of a FDA inspection without any letter #483's. I have experienced this and more. Make that third party auditor work to find something and end up with a very minor finding so he/she has something. Nothing makes me happier.