Three Reasons to Adopt Automated Validation in Quality Management Systems

August 10, 2012
Stephanie Sutton

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

My daughter has been learning how to ride a bike for the past year. She’s actually become quite adept at it, and for someone who loves to cycle, I am certainly proud. But there were certain obstacles to overcome to get to this point. We started simply with the tricycle – learning to pedal.

 

My daughter has been learning how to ride a bike for the past year.  She’s actually become quite adept at it, and for someone who loves to cycle, I am certainly proud.  But there were certain obstacles to overcome to get to this point.  We started simply with the tricycle – learning to pedal.  Then we switched to a “run-bike” to help learn balance.  Now we are on a two-wheeled bike with training wheels, and slowly beginning to take the training wheels off.  With each step forward, my daughter expressed a certain degree of fear – “will I be able to do this?,” she intimated. Once she made the leap to the next level, she realized how much easier biking can become.  Leaving the training wheels can be scary, but the freedom of two wheels is much better.

When I speak to customers and prospects about Quality Management Systems Validation, I get much of the same trepidation.  For many years, the concerns of software systems center around the validation of those systems.  After all, if the system fails to work properly, the company becomes liable and any repercussions will most likely not be pretty.

What is validation, really?  Well, at its core it is ensuring the system does what it is supposed to.  Interestingly enough, software developers validate their software every time a new version is released, when a new build is completed, even when a new line of code is added.  In the Life Sciences space, there is such an importance placed upon the validation of the system, that many companies will focus more on the validation capabilities than the actual functionality of the software.

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