Pharma LIMS
FDA 21 CFR Part 11 compliant pharmaceutical LIMS
Enterprise-grade LIMS for pharmaceutical QC labs requiring full 21 CFR Part 11 compliance, audit trails, and electronic signatures.
MRR
$14,320
+12% this month
Active
487
+23 this month
Churn
1.8%
-0.4% this month
$14K/mo
Verified revenue
73%
Choose annual
98.7%
Uptime SLA
<2min
Setup time
The Problem
Sound familiar?
21 CFR Part 11 compliance requires costly legacy systems
Audit trail gaps expose labs to FDA 483 observations
Data integrity failures lead to batch release delays
The Solution
Pharma LIMS fixes this.
21 CFR Part 11 Audit Trail
Immutable, timestamped log of every data entry and change.
Electronic Signatures
Two-factor e-signatures for result approval and batch release.
USP Method Templates
Pre-built method templates for USP dissolution, HPLC, and sterility tests.
How It Works
Set up in under 2 minutes. No complex configuration.
21 CFR Part 11 Audit Trail
Immutable, timestamped log of every data entry and change.
Electronic Signatures
Two-factor e-signatures for result approval and batch release.
USP Method Templates
Pre-built method templates for USP dissolution, HPLC, and sterility tests.
OOS / OOT Workflow
Guided out-of-specification investigation workflow with documentation.
Why not the alternatives?
Same result. A fraction of the price.
| Product | Price | Core feature |
|---|---|---|
| Pharma LIMS | $500/mo | FDA 21 CFR Part 11 compliant pharmaceutical LIMS |
| Enterprise tool | $149/mo | Overkill for most teams |
| DIY approach | 40+ hrs dev | High maintenance burden |
Integrates with your stack
Simple, Transparent Pricing
No per-user fees. No hidden costs. Cancel anytime.
QC Lab
- Unlimited samples
- 21 CFR Part 11
- E-signatures
- OOS workflow
Enterprise
- Multi-site
- ERP integration
- Validated CSV
- Dedicated CSM
Frequently Asked Questions
Is the system validated per GAMP 5?
Enterprise plan includes IQ/OQ/PQ documentation and a validation package.
Does it support 21 CFR Part 211 as well?
Yes — the GMP module covers cGMP documentation requirements for drug manufacturing.
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