P6M1 Introduction to Data Integrity

This activity presents the data environment in the pharmaceutical industry and the consequences of data alteration, omission, or falsification.It highlights regulatory challenges, individual and collective responsibilities, and the risks to product quality and patient safety.

This activity outlines the different types of data used under cGMP requirements and their lifecycle, from creation to archiving.It clarifies the concepts of raw data and metadata, and the need to ensure traceability and legibility at every stage.

This activity introduces the nine ALCOA+ principles and their practical application.It links each principle to workplace examples, emphasizing their role in compliance and the quality of documentation processes.