GMP Checklist for Data Integrity Audit – Information Technology and Computerized Systems

Disclaimer: This checklist, courtesy of Karen Ginsbury, is not complete nor is it the purpose of an audit to ask all possible questions or review all aspects of a topic.  

Data Integrity goes far beyond IT and Computerized Systems and the most important aspect of any audit is to get a feel for governance, planning, risk assessment and data integrity risk management while always being aware there could be outright fraud. Fraud is not, nor should it be, the primary focus of an audit until such time (and I hope you never reach that time) as diligent audit findings indicate such a possibility. Notwithstanding, any indication of the opportunity for or presence of fraudulent practice should be investigated until ruled out…or otherwise!

I have created a document, made freely available as a service to industry and regulators, which may be further distributed. Should any of the users have additions to the checklist, it would be wonderful if you would share them in the spirit of continual improvement in the comment section below.

Click here to download the GMP Checklist for Data Integrity Audits.


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