Protecting data integrity – Evaluating instruments in the lab

20 March 2024

With the shift towards digital transformation, connected workflows and integrated systems are essential for improving operational efficiencies and eliminating paper-based processes. Compliance with FDA 21 Part 11 CFR guidelines and EU Annex 11 requires features such as audit trails, access control, electronic signatures, and data backup. Violations of these guidelines often stem from data integrity issues, including improper access management, incomplete audit trails, and manual data entry errors. Maintaining personalized user accounts and complete audit trails is crucial to meet regulatory requirements and ensure data integrity throughout laboratory processes. In this application note, Sartorius provides a checklist for evaluating instruments and procedures to ensure compliance with data integrity regulations.