GXP meets Data Integrity: How to ensure data integrity in a GXP facility

GXP requirements regarding data integrity of data, practical examples and typical audit findings will illustrate does and don’ts

• How to ensure data integrity of raw data?
• Is paper based only still appropriate or do all facilities need to have electronic raw data?
• What are signals for data integrity problems?
• What’s the best way to use audit trails as a QA, study director or CRA?
• How to apply risk-based approaches when verifying data integrity of large raw data volumes?

These and many other questions will be discussed in the course of this seminar.
The seminar will help the participants to understand regulatory requirements and will highlight possible solution strategies.

The regulatory requirements on data integrity have changes significantly in the last years. A “data governance” concept, requiring deep understanding of data generation, migration, storage and archiving is expected and verified by authorities. Lack of data integrity is interpreted as significant GXP non-compliance and might result in the rejection of dossiers by assessors. Irrespective of the media (paper or electronic, text only or audio and image files, any file structure or format) the reliability of the data has to be ensured by appropriate measures. Irrespective of the fact that many computerized systems do have certain restrictions, GLP facilities are expected to take corrective actions even before the required software update is available.

This seminar will help to understand typical pitfalls that might trigger audit and inspection findings and illustrate the same based on real live examples. Based on the presentation of key concepts of data integrity the participants shall be able to verify the effectiveness of existing data integrity concepts and or implement the same successfully.

The participants are welcome to share question and tricky practical examples upfront. The examples will be anonymized and the answer will be included in the presentation.

Content:

• GXP requirements on data integrity
• What are raw data and how to ensure their data integrity?
• Data storage, migration and archiving
• Responsibilities of QA, QC, CRA with regard to data integrity
• Practical examples
• Question and answers

Seminar language is English.