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.
Good clinical practice
The first post in this series described the importance of organisational behaviour on the success of data integrity control measures. Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.
From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland
Global regulatory collaboration relating to data integrity remains a priority for MHRA and its international partners.
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.
In the October blog post we told you about the successful audit of the GMP Inspectorate under the JAP programme. Later that month the entire Inspectorate was assessed as part of the BEMA programme.
My name is Lynsay Hunter and I am the newest recruit to the MHRA laboratories inspection team, having previously worked in a variety of laboratory and quality assurance roles. My first MHRA event was the annual laboratories symposium held in …
The annual GCP Symposium was held by the MHRA on 20 September 2016 in Birmingham and was repeated on the 21 September 2016.
Earlier this year I represented the MHRA at the 10th Workshop on Recent Issues in Bioanalysis (WRIB).
Over the past few years we have seen our events grow in popularity; we have gone from 6 a year to over 30!