Since the MHRA released their data integrity guide back in March 2015, there has been a constant drip-feed of articles, blogs, commentary, and more worryingly, more guidance on the topic of Data Integrity. Lets add a free Data Integrity Checklist to the list!
The acronym “NADDIG” was jokingly introduced by Trevor in the PharmOut office. It stands for “Not Another Damn Data Integrity Guide!“. We can understand the anxiety and frustration in industry (it gives us palpitations too!) as we now have multiple guides on DI, all saying the same thing, but differently…or are they?
These guidelines don’t change the fact that you still must periodically check the aspects of your quality system that are used for collecting, analysing, reporting and storing data. To help you perform a “health check” on your paper and electronic systems, we have created a data integrity checklist for you that could be used as part of your self-inspection or internal audit program.
This data integrity checklist will help you to measure the “heartbeat” of your systems and point you to where there may be gaps for DI issues to occur in your product lifecycle. Use it as you walk through your facility to support your regular checks.
The checklist takes into account the ALCOA principles already embedded in your PQS according to GxP requirements. Also included are some checks that you may use to ensure that personnel do not have the “means, opportunity or motivation” to commit DI offences.
We hope that this data integrity checklist will be useful to you and we are sharing it at no cost. We do ask that if you do use it, please share your thoughts, suggestions and improvements with us in the comments section below.
Here’s to healthy systems!