What the inspector wrote
The chromatography data system in the QC laboratory was accessed by all analysts using a single generic account 'QCLAB' whose password was written on the instrument bench. The account held administrator privileges, including the ability to delete data files and modify audit trail settings. It was therefore not possible to attribute any acquisition, reprocessing or deletion in the system to an individual. The firm could not demonstrate that reported results for batches released since installation were the results originally generated.
Why it was cited
Attributability is the first letter of ALCOA for a reason. Once the inspector establishes that a shared account exists, every record the system has ever produced becomes unattributable, and every one of those records supports a batch that was released. The deficiency is classified on the batches, not on the login.
Administrator rights on the shared account make it worse: anyone could have deleted a failing result, and the site cannot prove nobody did. This is why the finding is usually written as critical and why it triggers a retrospective data review of released product.
What would have prevented it
- One unique login per person on every GMP system, enforced by the system, with a current user list reviewed against leavers and role changes.
- Separate administrator accounts held by IT or the system owner, never by the people generating results. Users should not be able to delete data or change audit trail configuration.
- Where licence costs are the reason for sharing, escalate to management with the regulatory consequence written down. The cost of a retrospective review is always higher.