Every Pill
Data-Trustworthy
CNWAYLab PharmaLIMS covers the full lifecycle across R&D, QC, stability, batch release, and retained sample management, serving 60+ leading pharma companies including Hengrui Medicine, Fosun Pharma, CSPC, and Yangtze River Pharma.
Pharmaceutical & Biotech Lab
Digital Solutions
From R&D and QC to pilot production and batch release, CNWAYLab PharmaLIMS provides an end-to-end compliant digital platform for pharmaceutical companies, serving 60+ leading enterprises.
Four Pain Points in Pharma Labs
Escalating Compliance Pressure
Multiple regulatory bodies (FDA, NMPA, EMA) — paper records and offline Excel cannot meet ALCOA+ data integrity requirements, frequently failing unannounced inspections.
Instrument Data Silos
High-value instrument data from HPLC, GC, Mass Spec scattered across different workstations, unable to flow back to business systems in real time — duplicate entry and transcription error rate as high as 8%.
R&D to Production Disconnect
R&D ELN and QC LIMS data cannot be connected end-to-end. Repeated reconciliation during Tech Transfer (TT) phase severely delays new product launch cycles.
Lengthy Report Release Cycle
Multiple concurrent SOP versions and multi-level review/signature chains — average batch release takes 5-7 business days per batch.
How CNWAYLab Transforms Pharma Labs
Unified R&D and QC Data Foundation
R&D ELN, QC LIMS, QMS, Stability Management (SMS) share a single source of truth for sample/product/process master data — full traceability from R&D to production.
Automated Instrument Data Aggregation
SDMS module enables bidirectional integration with Empower, Chromeleon, MassHunter and other chromatography/mass spectrometry platforms — raw data attached to batch records with zero manual transcription.
Electronic Batch Records (EBR)
Structured EBR + automated process verification + closed-loop OOS exception handling — batch release compressed from 7 days to within 24 hours.
Compliance & Audit-Ready
Pre-configured compliance templates for FDA 21 CFR Part 11, EU GMP Annex 11, and NMPA Data Integrity — CSV validation documentation ships with the system.
Real Data from Three Leading Pharma Companies
Hengrui Medicine
Full upgrade of R&D ELN + LIMS
R&D data reuse +210%, cross-project compound screening time reduced by 55%.
Fosun Pharma
Unified LIMS deployment across 14 subsidiaries
IT O&M cost -62%, enterprise data dashboard provides real-time cross-subsidiary benchmarking.
Yangtze River Pharma
Electronic Batch Records for sterile manufacturing workshop
Batch release from 7 days → 18 hours, zero data integrity observations.