Data Integrity Introduction, Challenges and Solution – Part 1

Data Integrity Introduction, Challenges and Solution – Part 1

Data integrity has become a central focus for laboratories, especially in regulated environments like pharmaceuticals. Accurate, reliable, and traceable data is critical for compliance with regulations such as 21 CFR Part 11 and EU Annex 11. Regulatory authorities take violations seriously, as seen in numerous FDA warning letters, making strong data integrity practices essential for audit readiness and operational trust.

Inside this white paper, you’ll learn:

• The concept of ALCOA+ and its regulatory significance
• Challenges related to ensuring data is attributable
• Issues with user and password management in paper and legacy systems
• Risk-based approaches to control and verify data integrity