Information Technology
The working group is concerned with any questions of information technology that may occur in the field of GxP-regulated testing equipment. The main topics involve the validation of laboratory computerized systems (concepts and practical implementation), and the impact of guidelines in GLP and GCP environments given by authorities, such as the US guideline 21 CFR Part 11 (FDA). In the working group meetings, a broad exchange of experiences about the usage of IT systems within test facility occurs.
The spectrum of topics is broad, ranging from those outlined in the "Handbook for Inspectors" about the IT aspects of "electronic archiving," to the use of new concepts such as validation risk management, and to the technical and legal aspects of electronic or digital signatures in GxP studies. The working group meets twice a year to work on current issues through presentations and discussions. Detailed results of the working group meetings will be published in the members’ area.
If you have any questions about this working group, please contact the working group leader:
Dr. Helmuth Morgenthaler
Borsigstraße 11
D-67063 Ludwigshafen
Tel.: +49 1739041739, Fax: +49 621-6339151
eMail: helmuth.morgenthaler@dggf.de
Welcome, you are on the page of the Working Group "Information Technology"!
The working group is concerned with any questions of information technology that may occur in the field of GxP-regulated testing equipment. The main topics involve the validation of laboratory computerized systems (concepts and practical implementation), and the impact of guidelines in GLP and GCP environments given by authorities, such as the US guideline 21 CFR Part 11 (FDA). In the working group meetings, a broad exchange of experiences about the usage of IT systems within test facility occurs.
The spectrum of topics is broad, ranging from those outlined in the "Handbook for Inspectors" about the IT aspects of "electronic archiving," to the use of new concepts such as validation risk management, and to the technical and legal aspects of electronic or digital signatures in GxP studies. The working group meets twice a year to work on current issues through presentations and discussions. Detailed results of the working group meetings will be published in the members’ area.
If you have any questions about this working group, please contact the working group leader:
Dr. Helmuth Morgenthaler
Borsigstraße 11
D-67063 Ludwigshafen
Tel.: +49 1739041739, Fax: +49 621-6339151
eMail: helmuth.morgenthaler@dggf.de
