In a recent letterdated June 17, 2024, the FDA raised significant concerns about the data integrity and management practices at a contract research organization (CRO), highlighting issues with their ISR processes during bioanalytical studies. This letter detailed several critical areas where data anomalies and mishandling led to questions about the reliability of bioanalytical study results. Here, we explore the FDA's ISR findings and discuss how LabWare's Bioanalytical LIMS and ELN platform could have mitigated these issues. 

Data integrity is fundamental across numerous industries, but the terminology, practices, and language can often be complex and inconsistent. This article aims to clarify the concept of data integrity within laboratories and illustrate how LabWare LIMS canplay a vital role in ensuring accurate, reliable data, specifically addressing and mitigating regulatory concerns around dry-labbing.