21 CFR Part 11 is a set of regulations established by the United States Food and Drug Administration (FDA) that defines how to set up compliant electronic records and signatures in the context of pharmaceutical, biotechnology, and medical device industries.

These regulations require companies to implement measures to ensure electronic records and signatures’ accuracy, reliability, and security, including appropriate technical and procedural controls.

A well-designed laboratory software boosts efficiency and productivity, improves inventory management, and simplifies audit procedures by ensuring process traceability and data security, which are critical to achieving Data Integrity.

Moving away from an old hybrid system of paper and computer programs is a step forward, and implementing a digitalization plan in your lab using laboratory software offers significant benefits.

In this presentation, we are going to visit some major data integrity scandals, present Data Integrity and the most common DI primary issues found by the FDA, and provide seven steps to help avoid data integrity failure.