Built for Pharma Compliance
End-to-End Quality Management Platform
PharmaLIMS is CNWAYLab's LIMS platform purpose-built for the pharmaceutical industry, deeply compliant with FDA 21 CFR Part 11, EU GMP Annex 11, NMPA, ICH Q10 and other international regulations. Covering raw material testing, in-process control, stability studies, and batch release workflows — empowering pharma enterprises to achieve a closed-loop from data to decision.
GMP Compliance Core Capabilities
From APIs and formulations to vaccines and biologics — full-chain quality management with compliance built into every step.
GMP Full Workflow Compliance
Raw material testing, in-process control, finished product release, and stability studies — all modules certified. Electronic signatures + audit trails meet ALCOA+ data integrity. Built-in FDA/NMPA/EMA regulatory checklists reduce audit preparation time by 80%.
Stability Study Management
Multi-dimensional scheduling for accelerated / long-term / intermediate conditions, automatic pull alerts, trend prediction and shelf-life estimation. Supports all ICH Q1A-Q1E stability conditions with automatic sample pull planning and expiration reminders.
Batch Release (QP Release)
Automatic release checklist generation, qualified person electronic sign-off, fully traceable chain of custody. From test data to CoA auto-output, supporting configurable release rules for multiple product types and markets.
OOS / OOT Investigation
Automatic deviation triggering with built-in root cause analysis templates (5Why, Fishbone, FMEA) and CAPA closed-loop management. Visual investigation progress tracking, automatic locking of out-of-spec batches, investigation conclusions linked to change control and risk assessment.
Method Validation & Transfer
Full lifecycle management of analytical methods with automatic validation report generation (USP <1225> / ICH Q2(R2)). Supports method transfer, verification and ongoing performance monitoring with automatic statistical analysis of linearity, precision, accuracy, and more.
Environmental Monitoring & Equipment Management
Particle, colony, temperature, and humidity trend monitoring for clean areas. Real-time limit alerts linked to electronic release decisions. Automatic equipment calibration reminders, online metrology records, and environmental data directly linked to batch release decisions.
Pharma-Specific Functional Modules
Covering the full quality chain from raw materials to finished products. 16 modules deployable on-demand, flexibly adapting to pharmaceutical labs of all sizes.
Raw Material Management
Material records / supplier qualification / incoming inspection — compliant from receipt, quality assured from the source.
Stability Studies
Protocol design / multi-condition scheduling / trend analysis — automated sample pull planning and shelf-life estimation.
Finished Product Release (CoA)
Automated CoA generation / QP e-sign-off — multi-market, multi-template, multi-language output with one click.
Deviation & CAPA
OOS/OOT automatic triggering / root cause analysis templates / CAPA closed loop — never miss a single deviation.
Method Validation
USP/ICH templates / automatic validation report generation — full analytical method lifecycle management.
Environmental Monitoring
EM data capture / trend alerts / limit-exceedance linkage — integrated clean area environment and release decisions.
Audit Trail & Electronic Signatures
21 CFR 11 full-field auditing / two-factor authentication / biometrics optional — every action is non-repudiable.
Regulatory Compliance Reports
FDA/NMPA/EMA templates / annual quality review / change control — audit preparation shrinks from weeks to hours.
From Sample Receipt to QP Release
A five-stage compliance closed loop where every step meets GMP's rigorous requirements for data integrity and traceability.
Sample Registration & Receipt
QR code / RFID receipt, automatic unique sample ID generation, batch import and checklist comparison. Verified on receipt — supplier qualification, expiry date, and storage conditions are automatically validated.
Test Execution & Data Capture
SOP-guided data entry, 300+ instrument direct data acquisition, real-time electronic signature verification. Every data point carries a timestamp, operator ID, and audit trail entry.
Result Review & OOS Interception
Dual-review workflow, automatic OOS/OOT flagging, trend analysis and alerts. Out-of-spec batches are automatically locked to prevent mistaken release, with complete review trail recording.
CoA & Report Generation
Automatic CoA generation per customer/regulatory templates, supporting multi-language and electronic seals. Full batch traceability chain closed — from raw material to finished product data, one-click export.
QP Release & Full-Chain Traceability
Qualified Person e-sign-off, end-to-end audit trail, optional blockchain attestation. QMS-linked — release equals closure; batches with open deviations are automatically blocked.
Begin Your GMP-Compliant Digital Journey
Book a 30-minute online demo and receive a pharma-specific solution proposal with ROI assessment report.
420+ pharmaceutical enterprises have already chosen PharmaLIMS.