Data Integrity Checklist for Life Science Compliance

This document is a checklist designed for the life science industry, focusing on data integrity practices in the context of Pharma 4.0 and Validation 4.0. It outlines the importance of data integrity as a foundational element of digital trust, emphasizing that it goes beyond mere compliance to support accuracy, consistency, and security across systems. The checklist is formulated in accordance with regulatory standards such as FDA 21 CFR Part 11 and EU GMP Annex 11, and it aims to help organizations integrate traditional practices with modern expectations. It includes checkpoint questions to verify readiness in areas such as data capture, transfer, and protection, ensuring that processes are digitally enabled and risk-based. Additionally, the document encourages organizations to build inspection readiness into their operations rather than treating it as a one-time event. By following this checklist, organizations can align their practices with current regulatory requirements and prepare for future challenges in the life sciences sector.