FDA Warning Letter Highlights Need for Traceable Lab Data in Pharma Systems

An article for software developers argues that laboratory applications in regulated pharmaceutical settings must preserve the evidence behind test results, not just the final reports. It notes that a pharmaceutical LIMS links samples, specifications, methods, instruments, analysts, and review history, which must be retrievable together. The piece cites an October 2026 FDA warning letter to TSP Solutions Pte. Ltd., which found that submitted Certificates of Analysis and batch records did not demonstrate that required testing had been performed. It also explains that changes to laboratory records need audit trails capturing previous values, new values, users, timestamps, and reasons. The author points to FDA data integrity guidance as the basis for these design requirements.