Pharmaceutical QC Laboratory LIMS Implementation
How a pharmaceutical manufacturer achieved FDA 21 CFR Part 11 compliance while reducing batch release time by 58%.
The Problem: Hybrid Systems and Data Integrity Gaps
Apex Pharmaceuticals operates three QC laboratories supporting a mid-size generic drug manufacturing operation. They'd just received a Form 483 from an FDA inspection with three observations related to data integrity and electronic records.
Incomplete Audit Trails
Legacy LIMS tracked changes to final results but not raw data
Weak Access Controls
Former employees still had active accounts, analysts could modify results they shouldn't
Inadequate E-Signatures
No two-factor verification, same credentials for login and signing
Excel Everywhere
47 active spreadsheets for intermediate calculations—not Part 11 compliant
The Approach: Compliance First
Documented all Part 11 requirements and ALCOA+ principles against current state.
Selected pharma LIMS with native Part 11 support, biometric signatures, and bidirectional instrument integration.
Migrated 5 years of data, executed IQ/OQ/PQ, generated ~2,400 pages of validation documentation.
Trained every user on the why behind the system, staggered go-live across three laboratories.
The Results
Apex passed their follow-up FDA inspection with no repeat observations.
| Metric | Before | After | Change |
|---|---|---|---|
| Audit trail completeness | ~60% | 100% | Complete |
| E-signature compliance | Non-compliant | Fully compliant | Achieved |
| Uncontrolled spreadsheets | 47 active | 0 | Eliminated |
| Batch release time | Baseline | Improved | -58% |
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