April 2014

Which Metric Really Drives Your Business?

Posted on Apr 26th, 2014 by Norm Howe

Sales PitchEverybody has a favorite business metric.  Read any best selling how-to manual and somebody will try to sell you an abstract parameter that will surely make you successful.  All you have to do is tweak up that metric and your bonus will break the stratosphere.

My favorite metric is profit.  Profit is a business’s most critical measure.  Without profit, everything else is irrelevant.  You can have the best compliance record in the business and you will soon be out of business.  You can have the best customer satisfaction ratings in the business and you will soon be out of business.

Do We Really Have to Validate? Really??

Posted on Apr 20th, 2014 by Norm Howe

validation overloadActually, no, you don’t.  But you might want to know what the conditions are.  First, you need to know the difference between validation and verification.  Let’s review how FDA defines validation.  From FDA's Guidance for Industry, Process Validation:  General Principles and Practices

“…the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”