Staying in compliance with procedures and Regulators…It shouldn’t be that hard.  You write up the way you will run your business based on regulations and industry practice and you run your business that way.  What’s the problem?  Creating the system is mundane, but not too difficult.  It’s the implementation, upkeep, the continuous improvement, the focus – that’s the hard part.  I guess the real problem is that it takes time and discipline.  We are all so busy trying to do more, get more done.  Cutting corners and skipping a step is where we get into trouble.  In my experience, keeping things simple does a lot.  Our technical training and background leads us to over engineer processes.  Also, don’t be afraid to cheat!  Make checklists and keep your procedures in front of you.  Following a cake recipe is easy as you keep it in front of you and follow line by line.  Take the recipe away and you’re surely going to ruin the cake.  Do the same with your business processes.  Don’t try to memorize them.  Just know that they are there and look at them.  As adults we have the luxury of not being “tested” every week.  Don’t be afraid to test and score yourself.  Otherwise you won’t know if you’re getting better or worse.  At Pearl IRB we are keeping life as simple as possible, while meeting the regulations.  You won’t see 30 some forms from us, or 50 SOPs.  We’re keeping the business simple so we can focus on patient safety.  This is where efficiency and experience pay off.