CSV is an important part of the development and use of computer systems within clinical trials and it applies not just to specialist eSystem vendors, but also Clinical Trials Units (CTUs) or Clinical Research Organisations (CROs) offering randomisation and Interactive Response Technology services, specialist analytical software developers and sponsor organisations developing their own software solutions. 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. Hello and welcome to the latest MHRA Inspectorate Blog post, my name is Balall Naeem, GCP Inspector, and you may already have read my previous posts on Reference Safety Information (RSI).
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