LIMS for Pharmaceutical & Drug Testing Labs
ISO 17025 · 21 CFR Part 11 · Audit Trail · GMP
LabSync for pharma labs: ISO 17025, 21 CFR Part 11 audit trail, electronic signatures, data integrity, GUM uncertainty, and GMP-compliant workflows.
Key Features for Pharmaceutical & Drug Testing
21 CFR Part 11 audit trail
Every change is immutably logged with before/after values and actor identity.
Electronic signatures
Verifiable digital sign-off on results and certificates.
Version control
Manage test method and certificate versions per regulatory standards.
Data integrity
SHA-256 hash chain and append-only logs prevent retrospective data modification.
GUM uncertainty reports
Calculate expanded uncertainty for process measurement instruments.
Customer portal
Clients download certificates and verify the audit trail independently.
Who uses LabSync in this industry?
- ✓Calibration labs serving pharmaceutical manufacturers
- ✓QC departments at pharma factories needing GMP-compliant systems
Frequently Asked Questions
Does LabSync support 21 CFR Part 11?
The system has an append-only audit trail, SHA-256 hash chain, and electronic signatures that satisfy Part 11 requirements.