Lesson Code: DTI-1001 (PREMIUM LESSON) An overview of data integrity in regulated industries and its essential role in assuring product quality. Key data integrity concepts in GxP environments are explored along with regulatory requirements and expectations. The critical role of personal responsibility in maintaining data integrity compliance is also covered.
Data integrity is fundamental in ensuring medicines are of the required quality. Over the past number of years, the FDA, European regulatory agencies and others have increased their focus on the quality of data produced in regulated industries and have uncovered a number of areas of concern. Regulatory requirements for data integrity apply equally to manual (paper) and electronic data.
The regulatory viewpoint is that if data are not valid and trustworthy it is a sign that an entire operation or facility is out of control and cannot assure the quality of its products.
This lesson explains why data integrity is so critical, the key areas of concern to regulators, what regulators expect, and the ways in which data integrity can be built into a company Quality Management System.
The goal of the lesson is to communicate and reinforce the criticality of correct recording, storage and traceability of data produced in GxP environments. There is a particular focus on personal responsibility in ensuring data integrity.
Having taken the lesson, users should be able to:
The following key messages are communicated:
Duration: 30 mins (lesson content and associated assessment).
Prerequisites: None
Assessment: 10 Multiple Choice Questions.
Download the Product Sheet with additional info and contact details:
Europe:
EU_Data Integrity Product Sheet.pdf
USA:
US_Data Integrity Product Sheet.pdf