Validation Center™

I recently sent some thoughts on validating a data warehouse to a colleague working with a clinical data system.  Data warehousing is a complex topic, but that has never stopped me before.  I am reproducing my thoughts almost verbatim below.  Feel free to disagree or add to the conversation…

You now understand the principles and reasons to do risk based computer system validation. You even know some examples of how to apply the approach from ICH and the FDA. Last time, I showed you how to measure the risk of your systems and how to prioritize each feature based on risk using a simple but powerful risk assessment how-to. Now it’s time for the payoff.

Because it’s the right thing to do…

This week, I will outline a step by step approach for performing a risk assessment.  Your company probably has a procedure for doing this so you should follow along with that.  If your company does not have one, you should write one.  Need help?  Drop me a line.

The world is now convinced that a risk-based approach is the way to go.  We understand why regulators want us to use risk to focus our efforts and we understand how well applied risk management will lead to safer, more effective products, and ultimately to happier regulators.  If you are not among the convinced, go back and read all of my previous posts.

In June 2006, FDA (CDER and CBER) adopted the ICH document, "Quality Risk Management".  Taken in context with the other FDA guidance, we can gain much insight into how to do Risk Based Computer System Validation in a way that achieves higher quality and satisfies our regulatory obligations. 

FDA intends to amend 21 CFR Part 11.  According to George Smith of FDA, a draft proposed amended regulation is in the clearance process.  Along with the amended regulation, FDA will issue a new guidance to replace the 2003 guidance.  They have not publicized a date for draft release, but sources say FDA is targeting the first half of 2007.  Until then, do we have an idea as to how the amended regulation and its promised companion guidance will change what we do today?  Here are a few clues:  Read the August 2003

Risk based validation and the road to reasonableness…  Those of you who have been in on of my classes recently will understand why I answered the headline question with, “It Depends.”  It has become an inside joke of mine that I never give a straight answer.  By the time you finish one of my workshops, you understand why, “It Depends” is the most accurate answer to just about any question about validation.As professionals, we want our products to be safe.  As professionals who want to stay out of trouble with regulatory agencies, we want our products to be safe.  You can’t pos

One of the key benefits of Validation Center™ is the interaction with other professionals facing CSV challenges.  I will personally try to drive this collaboration.  This Blog is a start.  In addition to my personal pearles (or - lessons from the School of Hard Knocks), I will invite other software quality and computer experts to weigh in with their two cents.  I hope you will check back often to see what others are saying. --Steve