Abstract

Sponsors' Perspective on Data Integrity

Bodo Lutz, Data Integrity Officer, Novartis

Data Integrity is an important aspect of the proper handling of data in processes and systems related to clinical research and development. Issues related to DI is widespread, as cases of non-compliance have been observed not only in the GMP regulated environment but also in the good laboratory practice (GLP) and good clinical practice (GCP) area.

Non-compliances published by the European Medicines Agency (EMA) or warning letters from FDA show examples from companies all over the world. It is a global issue.

The principles of Data Integrity should be embedded in related defined procedures to help assure that Data Integrity is a consequence of every specific GxP activity performed.

This presentation will show potential initiatives which can support the detection and/or mitigation of Data Integrity risks as: educating and training of personnel, Risk Management, Technology and IT Systems and Governance of Data Integrity.