Business success is more than regulatory compliance.
I spent this past week in Chicago, leading a workshop on software validation for the medical device industry, and we had extensive discussion on FDA regulations for Quality Systems (21 CFR Part 820), as well as electronic records and electronic signatures (21 CFR Part 11). Participants included a group of software developers from Europe, as well as a group of senior ERP consultants from the US. As we worked our way through the regulations section by section, line by line, I realized once again the extent to which, from a business perspective, regulatory compliance is just one aspect of business success. To be successful, a medical device manufacturer, or a pharmaceutical manufacturer, must do a lot of things right. It must bring in revenue, manage costs, meet delivery commitments, maintain quality, and a host of other things. But FDA compliance only addresses one of those dimensions: quality. FDA doesn't care if you properly forecast demand, increase sales, control your costs, accurately plan material, or manage capacity--in fact, FDA doesn't even care if you stay in business. By law, FDA only cares about one thing--that as long as you are
in business, you design and make product that is safe and effective.
Sometimes I think that companies lose sight of the fact that, although regulatory compliance is mission-critical, you are not in business to be compliant. You are compliant to be in business. But to be successful, you must do much more.