CaliberLIMS
GMP pharma LIMS for compliant, paperless quality control labs
About CaliberLIMS
CaliberLIMS is a laboratory information management system from Caliber Technologies, built for pharmaceutical and other regulated labs. It manages samples, stability studies, instruments, glassware, and reserve samples across 16+ modules, with a built-in ELN and audit trails aligned to FDA 21 CFR Part 11, EU Annex 11, and GMP. Caliber has sold the product since 2001 and positions it as a route to fully paperless QC labs.
Pros & Cons
Pros
- Strong compliance focus with audit trails, e-signatures, and 21 CFR Part 11 and Annex 11 support that ease audits
- Electronic raw data and COA templates mirror traditional paper formats, which eases the move to paperless
- Purpose-built pharma QC modules such as stability, OOT limits, analyst qualification, and dossier generation
- Integrates with ERP, QMS, CDS, and lab instruments
- Vendor with 25 years in pharma informatics and a wider suite (QMS, APQR, batch records) from the same company
Cons
- Reviewers describe the interface as not very user-friendly, with modules that could flow better
- Weak built-in task tracking and notifications, per user reviews
- Some users report recurring bugs and slow support responses
- Can slow down with large datasets
- No public pricing; quote-only enterprise sales
Key Features
End-to-end sample management
Tracks every sample from login through testing to batch release with standardized workflows and trend analysis.
Stability study module
Pre-defines stability protocols, schedules pull points, and monitors shelf life, safety, and efficacy results in one place.
Built-in ELN and electronic raw data
An electronic laboratory notebook and raw-data templates replace paper worksheets for analysts.
Regulatory compliance
Audit-trails every transaction and supports FDA 21 CFR Part 11, EU Annex 11, GMP, and GAMP-aligned validation.
Instrument and system integration
Connects to ERP, QMS, DMS, CDS, and file- or port-based lab instruments to capture data without transcription.
Out-of-trend configuration
Sets OOT limits per test using three-sigma or custom ranges, comparing stability results to the initial or previous station.
Dossier generation
Compiles a password-protected batch e-booklet with COAs, raw data, instrument reports, and vendor reports.
Analyst qualification
Qualifies analysts on complex techniques through batch execution against limits and on simpler techniques through Q&A.
Reserve sample and glassware tracking
Manages reserve sample inventory and withdrawals, and tracks QR-coded glassware with a single scan.
Pricing
- 16+ LIMS modules
- On-premise or cloud deployment
- Implementation and validation support
- Quote-based on sites, users, and modules
Best For
Pharmaceutical QC labs
Run sample testing, specifications, and batch release with full audit trails for GMP inspections.
Stability testing programs
Schedule and track stability studies and flag out-of-trend results across time points.
Paperless lab transformation
Replace paper worksheets and logbooks with an ELN, electronic raw data, and scannable glassware.
Audit and regulatory readiness
Generate batch dossiers and keep compliant records for FDA and EU regulator inspections.
