Transforming Healthcare in Lasting and Meaningful Ways

It is one thing to be alive, its another to live. Quality of life means continuous innovation. As technology is revolutionary, regulation is evolutionary. That key difference is why we exist. To bridge the gap between the regulatory glacier and the need for thoughtful refinement. OpenReg is about the practical understanding of regulation and the tools to help navigate it from the submission to the manufacturing floor. In today’s world of regulation is a hamper on industry we have to ask if company’s are up to the task to comply with what is right in the treatment of their employees, much less the products they make. Quality issues happen. Even to 5 star companies. The right regulations keep us safe as they are there due to the lowest common denominator actors in industry. It is not always a question about integrity, but of resources, of understanding, and ingenuity. The intent of this site is to help understand how to live quality and thereby meet the intent of the often vagueness of the regulatory text.

I believe in what quality professionals do. I have been doing this for 20+ years. I am a nerd and I consider myself quite weird when you get down to it. I love talking about this stuff. I also hate the status quo in our industry. I understand it but I hate it. I am tired of having to do things because of the lowest common denominators in our industry. I appreciate the human nature of our business, but the ridiculous BS excuses I have heard in this industry is worrisome. My intent is to point out the madness in the sector both in the regulation and in how it is administered. I want to talk about what has to be done versus what should be done. I want to talk about the bad practices that make this industry expensive, puts the public at risk, and makes people use the phrase "and the drug companies..." in the same vein as snake oil salesmen.