Explore Resources
USFDA Warning Letter – Data Deletion & Audit Trails
Electronic Files Could Be Deleted
Electronic files from lab systems could be deleted with no adequate controls. HPLC/GC control software did not have appropriate audit trails enabled for significant changes.
Where This Issue Shows Up
QC labs + stability labs; also CRO labs running OTC/API testing.
What Had Happened
- 1
Electronic files from a lab system could be deleted (no adequate controls).
- 2
HPLC/GC control software did not have appropriate audit trails enabled for significant changes.
Why It Matters
Even if you think you're compliant, regulators focus on whether the system prevents/records deletion and modification of GxP data.
Bad Consequences
Regulators typically demand:
retrospective review of affected data,
re-testing / re-qualification,
and proof that electronic records are trustworthy.
Our Mitigation Strategy
What "audit-ready software" must enable:
1Technical Controls
Implement write-once / immutable storage for raw data + metadata.
Configure deletion = prohibited (or requires controlled workflow with reason + dual approval).
Audit trail must capture who/what/when/why, and be retained as long as the record.
Add a "data integrity monitor": alerts for deletions, method edits, reintegration, reprocessing, aborted runs.
Category
Need Help with Data Integrity?
Our solutions help prevent these issues. Get in touch to learn more.
Request a Demo