Another one for the Gipper!

Who Validates the Validators?

In the medical device industry, you are required to show that employees assigned to perform certain functions (e.g., validation) are qualified for that role. This usually takes the form of either history (resume) or training (records). So in a way, the process validates the validators.

As the legions of Rome conquered countries, they co-opted local men into the army. The normal Roman trooper was worried about where the loyalty of these co-opted troopers lay, especially when they were on guard duty, and developed the saying

Quis Custiet ipso custidies? (Who will Guard the Guards.)

Hence; Who will police the police? - Who will watch the watchers? Etc.

With the validators it has got to be - The Regulators!!!

Alex Kennedy

www.fda-compliant.net