Catalyst Laboratory Information Management System
One paperless platform for samples, tests, results, stability studies and instrument datafully compliant with FDA 21 CFR Part 11 and ALCOA+ data integrity.
From Sample, Tests to Signed CoA, Digitally
Catalyst LIMS is a modern laboratory information management system built for pharmaceutical, biotech and medical device QC labs. It replaces paper worksheets, logbooks and spreadsheets with a validated, audit-ready digital workflow — from sample receipt through testing, review and result release.
It manages the complete QC process: sample login with barcodes, automated test allocation, direct instrument data capture, specification-based result evaluation, OOS/OOT investigation routing, stability study, reagent, columns and standard tracking, and one-click Certificate of Analysis (CoA) generation.
Catalyst LIMS integrates natively with the rest of the Catalyst platform — QMS, eLogBook, eBMR, Calibration & Maintenance and APQR — and with your ERP and analytical instruments, giving you a single source of truth for QC data.
What Makes Catalyst LIMS Different
Purpose-built for regulated pharma QC labs — configurable workflows, instrument connectivity and inspection-ready data integrity out of the box.
Key Features
- • Complete Sample Lifecycle Management - From sample login and barcoding to storage, retention and disposal — track every sample, aliquot and sub-sample with full chain-of-custody and status visibility.
- • Electronic Worksheets & Test Execution - Replace paper worksheets with guided electronic test execution — methods, specifications, calculations and acceptance criteria enforced at the point of entry.
- • Direct Instrument Data Capture - Acquire results directly from HPLC, GC, UV, FTIR, dissolution apparatus, balances and other lab instruments — eliminating manual transcription errors.
- • FDA 21 CFR Part 11 Compliant by Design - Role-based access, electronic signatures, secure time-stamped audit trails and ALCOA+ aligned data integrity controls built into every workflow.
- • OOS / OOT & Deviation Workflows - Automatic out-of-specification and out-of-trend detection with configurable Phase I and Phase II investigation routing, CAPA linkage and full traceability to batch.
- • Stability Study Management - Schedule and execute long-term, accelerated and intermediate stability protocols with automatic pull-point generation, trend charts and regulatory-ready reports.
- • Reagents, Standards & Columns Tracking - Track receipt, qualification, usage, expiry and traceability of reagents, reference standards, working standards, columns and consumables.
- • Automated CoA Generation - Generate regulatory-ready Certificates of Analysis automatically once testing is complete and reviewed — electronically signed, version-controlled and ready to ship.
Catalyst LIMS enables QC laboratories to move from disconnected paper worksheets and spreadsheets to a fully digital, secure and compliant laboratory informatics platform. Its configurable design and instruments integration reduces implementation time and training effort, so labs go live faster — while consistently meeting global expectations including FDA 21 CFR Part 11, EU GMP Annex 11, GLP and ALCOA+ data integrity.
Barcode-driven sample login and tracking.
Automatic test allocation and workload balancing
Specification-based auto pass / fail evaluation
Trending, SPC and statistical reporting
Multi-site, multi-lab and multi-role support
ERP, QMS, eBMR and ELN integration
Frequently Asked Questions (FAQ's)
What is a Laboratory Information Management System (LIMS)?
A Laboratory Information Management System is a software that manages the flow of samples and associated data through a laboratory. It handles sample login, test allocation, method execution, result capture, specification evaluation, review, approval and reporting — replacing paper worksheets, spreadsheets and standalone logbooks with a single validated digital platform.
Is Catalyst LIMS compliant with FDA 21 CFR Part 11?
Yes. Catalyst LIMS is designed for FDA 21 CFR Part 11 and EU GMP Annex 11 compliance, with role-based access control, electronic signatures, secure time-stamped audit trails and ALCOA+ aligned data integrity controls.
Can Catalyst LIMS capture data directly from analytical instruments?
Yes. Catalyst LIMS integrates directly with HPLC, GC, UV-Visible, FTIR, dissolution apparatus, balances and other laboratory instruments, capturing results electronically and eliminating manual transcription errors.
Does Catalyst LIMS handle stability studies and OOS investigations?
Yes. The system supports long-term, accelerated and intermediate stability protocols with automatic pull-point scheduling, trend charts and regulatory-ready reports. It also automates OOS and OOT detection with configurable Phase I / Phase II investigation workflows and CAPA linkage.
Does Catalyst LIMS integrate with ERP and other quality systems?
Yes. Catalyst LIMS integrates with ERP systems for master and batch data, and connects natively with the rest of the Catalyst platform — QMS, eBMR, eLogBook, Calibration & Maintenance and APQR — giving you a single source of truth for quality and manufacturing data.
How does Catalyst LIMS improve data integrity in the lab?
Every entry is validated in real time against predefined methods, specifications and calculations. Out-of-range values trigger alerts, all changes are captured in an immutable audit trail, and results are e-signed — eliminating transcription errors, illegible entries and missing signatures.
Ready to Modernise Your QC Laboratory?
See how Catalyst LIMS digitises your sample workflow, captures instrument data automatically and delivers inspection-ready records — end to end.
Schedule a Free Demo