FDA accepted, shared validation foundation

Over the years, I have worked in both regulated and non regulated environments in the health care / life sciences area. The predominate difference in the two areas is the amount of rigor required for development or implementation of IT solutions. While I am very much in favor of good process, I also am a big fan of eliminating redundant, or non value add process. Looking at the current situation, there is a blend of both.

We need to keep the rigor imposed by the regulatory agency compliance directives, good process is after all, what they are after. We also need to work with the regulatory bodies to optimize these processes across areas.

A first target for this effort is the validation exercise for commercial applications. As a part of all implementations of COTS or customized applications in a regulated area, the application must be validated and the vendor audited. For a large, frequently used application / vendor combo, this results in duplicate work happening at every customer implementing the application.

If we can eliminate the duplicate work with a standard for vendor audit and foundational application certification for use, recognized by the FDA and other regulatory agencies, we would save millions of dollars across the industry every year.

To this end, I am working with some folks from across the industry to begin the effort needed to get to an acceptable standard. If you have interest or thoughts on this, contact me, let me know your feedback and how you can help.