People. Progressive. Principled

GXP data integrity culture and unity


If you turn to that font of all known knowledge, the internet and search the term “data integrity” you will find a common definition of “maintaining and assuring the accuracy and consistency of data over its entire life-cycle”. All in all this is not a bad definition.

The concept as defined by the regulators of our industry is pretty much the same thing.

The subject of data integrity seems to be a particularly vexing one for the regulatory inspector. Glance at some of the articles recently posted on the web and you will encounter some horrifying tales of fraudulent data, bad practices and incompetent data recording which fly in the face of anything required by data integrity principles. There is a massive problem out there folks with real and present danger for us patients taking our prescribed medicines. Take a look at the next prescription drug you might encounter and check out where it is made. Chances are it will be the other side of the world and it’s this world wide industry that presents the challenge to the regulators. It’s all about unity and consistency of approach. The regulators see this and are fighting back with their promotion of a Data Integrity Culture.

Data Integrity Culture, what’s that?

In a nutshell it’s belief in what you do in an environment where such belief is supported by all. If you believe in the need for high quality data and have the knowledge to recognise it when you see it, then compliance becomes automatic and we can all sleep more easily in our beds. So, how to do this? One way is to put in place a team seeking to promote the kind of open culture communication which supports data integrity and get them working with their colleagues to bring us all in to one space with one vision. Importantly for managers they must support this process by adhering to an open culture and leading by example. “Led from the top, powered from below”. This is not looking for perfection but an environment where if a mistake is made then it is visible and out in the open, comprehensible and appropriate action can be taken to resolve the issue. The alternative invites, failure to detect bad practice or even fraud, regulatory compliance failures and possible sanctions but most importantly danger to patients.

 

A McCallum

Senior Manager, Quality

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