IT

The working group deals with all information technology issues that may arise in the area of ​​GxP-regulated test facilities. The main topics are the validation of IT systems in the test facilities (concepts, risk assessment and practical implementation) and the effects of official guidelines (e.g. the European or international receiving authorities) in the GLP, GCP and GMP environment, such as the US Guidelines CFR21 Part 11 (FDA) or GAMP 5. In the working group meetings, there is a broad exchange of experience in the use of IT systems in the test facilities. The range of topics is broad and ranges from the explanations in the “Handbook for Inspectors” to the IT aspects of “electronic archiving” to the use of new concepts such as risk management in validation or the technical and legal aspects of electronic or digital signatures  in GxP studies. The working group meets twice a year to work on current topics through presentations and discussions. The detailed results of the working group meetings are then published in detail in the members’ area.

The working group currently has about 70 registered members and is headed by Dr. Ronald Schmidt.