Stop Calling It Backup: Achieving Scientific Data Immortality
A critical batch of drug tablets failed stability testing in a pharmaceutical Quality Control (QC) laboratory six months ago, and the regulatory agency has requested an audit of all supporting analytical data, including the raw instrument files and audit trails.
The lab manager confidently states, “It’s okay, we have a backup!” However, the daily backup system was designed for disaster recovery (e.g., a server crash). It only retains data for 90 days. It ensures business continuity and does not satisfy long-term regulatory retention requirements. The raw instrument data files from six months ago are gone.
This lab was relying on a short-term, operational backup strategy. They cannot produce complete, compliant data packages (raw files, audit trails, and metadata) from six months ago. The regulatory agency deems the batch data unreliable, leading to a potential audit finding, significant compliance risk, and possibly a forced product recall or inability to release future batches.
Read More
