This post focuses on Computer System Validation (CSV) and is a combination of a case study seen at a single organisation and some of the common findings GCP Inspectors have seen across a number of recent inspections.
I joined Inspections Enforcement and Standards (IE&S) division of the MHRA in June 2014 as a GCP Inspector and I conduct GCP Inspections. I have been at the MHRA since May 2005 and worked in a variety of roles across our Vigilance and Risk Management in Medicines (VRMM) and Licensing Divisions. Prior to starting my current role I was working as a Senior Clinical Safety Scientists within the Agency's Clinical Trials Unit.
I have a Bachelors in Pharmacology and a Masters in Computer Based Information Systems.
Hello and welcome to Reference Safety Information II. Hopefully you will all have read my first Reference Safety Information (RSI) post which focused on how the RSI should be Identifiable, Approved and Consistent.
My name is Balall Naeem and I have been with the MHRA for more than 10 years now. In that time, I have worked across 3 different Divisions in a number of roles. The ones most relevant for this topic would …