Computerised System Validation
Computerised System Validation
Our French colleague Karine has 17 years experience in performing Computerised System Validation (CSV) and preparing for inspections in an international environment. Karine has prepared and attended audits by the FDA, the EMA, the MHRA and much more.
As you might know, in our industry it is mandatory to validate any machine or computer system before you put in production, be it in manufacturing, in your laboratory, in clinical research and in any other regulated part of the process.
Karine can also draft SOPs and train your teams on how to do Computerised System Validation according to GAMP5.
Such CSV can be done on site or remotely if relevant.
For more information, contact Karine at k.i.renault (at) pharmarketing.net : she will help your organisation prepare for an inspection!