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Pharmaceutical Solution — GMP/GDP/GSP standards · ERP · CX · Data · IoT · Robot

Pharmaceutical Solution · GMP/GDP/GSP

Pharmaceuticals — GMP-compliant, safe & fully traceable.

Platforms ERP + CX + Data for pharmaceutical businesses: manufacturing, testing, distribution, and compliance 100% GMP/GDP/GSP with FDA 21 CFR Part 11.

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🧪 GMP/GDP compliance🏷️ Batch number/expiry traceability❄️ Monitored cold chain
Industry challenges

Tough challenges in the pharma industry

Strict compliance, complete traceability, and the cold chain — DBIZ resolves each bottleneck.

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Strict GMP/GDP compliance

Ensure standards-compliant pharmaceutical manufacturing, storage, and distribution.

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Control drug quality & safety

Track testing, trace materials, and ensure drug safety.

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Manage batch numbers & expiry dates

Lot numbers, expiry dates, product recalls, and supply chain control.

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Cold chain & storage

Maintain 2–8°C, monitor continuously, prevent spoilage.

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Records & audit trail

BMR, CoA, e-signatures — compliant with FDA 21 CFR Part 11.

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Distribution & recall

Tenders, hospitals/pharmacies, fast batch recalls when needed.

Comprehensive solution

Five technology layers that resolve every bottleneck

From manufacturing, sales, and data to devices & robots — on one platform.

🛡️ AI ERP

Comprehensive GMP-compliant operations

From R&D, production (BMR), and QC/QA to GSP warehousing & distribution.

✓ R&D: drug formulations, clinical trials, registration dossiers (eCTD)
✓ Electronic Batch Manufacturing Record (BMR) per SOP; MES (OEE, ±0.01g weighing, serialization label printing)
✓ QC/QA: Batch Release & CoA, stability study, deviation/OOS/CAPA
✓ GSP warehouse: batch/registration number/expiry (FEFO), 24/7 monitored cold storage
✓ Distribution & cold chain: GPS refrigerated trucks, e-POD, temperature excursion alerts
✓ Pharma finance: batch costing, health insurance, drug-price reporting (TT04)
Comprehensive GMP-compliant operations
👥 AI CRM / CX

Serving hospitals, pharmacies & doctors

Partnering with healthcare providers, fully compliant.

✓ B2B CRM for hospitals/pharmacies/distributors, supply contracts, tendering
✓ 24/7 drug-information support, ADR (side effect) & complaint management
✓ Healthcare-partner loyalty, training & professional seminars
✓ Marketing compliant with drug advertising regulations, segmentation by specialty
✓ After-sales & Pharmacovigilance: ADR reporting, product recall, post-marketing surveillance
Serving hospitals, pharmacies & doctors
📊 Data + AI

Smart analytics & forecasting

Make decisions based on production, quality & pharma-market data.

✓ Real-time BI for production/sales, compliance dashboard (GMP/GDP/GSP)
✓ Drug demand forecasting (AI/ML) by season/epidemic, expiry planning
✓ Market analysis (ATC code, physician prescribing), public/private/OTC segmentation
✓ Optimize pricing by channel (health insurance/OTC), simulate drug-pricing scenarios
✓ Data warehouse unifying MES/LIMS/ERP, integrated with social insurance/tenders
Smart analytics & forecasting
📡 IoT devices

Monitoring equipment, environment & cold chain

DBIZ integration & operations GMP-grade IoT devices 24/7.

✓ Equipment monitoring (tablet press, mixer, coater) — OEE, vibration/temperature/pressure
✓ Monitor 2–8°C cold-storage temperature/humidity, threshold alerts, GSP/GDP reporting
✓ Cleanroom monitoring: particle count, pressure differential, GMP Grade A/B/C/D
✓ Predictive maintenance & automatic calibration for devices
Devices integrated into ERP/MES/SCADA — data stored by batch, GMP-compliant.
Monitoring equipment, environment & cold chain
🤖 Robotics & automation

Automated packing – sorting – inspection

DBIZ consulting & integration cleanroom-grade robots.

✓ Robots for blister/carton packaging and palletizing, vision packaging inspection, 70% less labor
✓ Robots sort by batch/expiry (FEFO), up to 3,000 boxes/hour
✓ Cleanroom-grade AGVs transport materials, cutting internal costs 60%
✓ Vision AI inspects packaging/labels (expiry, batch) — 600 products/min, 99.5% accuracy
Robots synced with WMS/MES; FDA & GMP compliant on quality control.
Automated packing – sorting – inspection
Benefits & ROI

Results for pharmaceutical enterprises

Typical figures when deploying DBIZ solutions (varying by each business’s current state).

100%
GMP/GDP/GSP complianceFull audit trail per FDA 21 CFR Part 11.
99.5%
AI inspection accuracyVision AI detects packaging/label defects.
−70%
Packaging laborRobot blister/carton/palletizing.
−60%
Internal transport costsCleanroom-grade autonomous AGVs.
3.000boxes/h
Sorting speedBy batch & expiry (FEFO).
2–8°C
24/7 monitored cold chainInstant alerts when thresholds are exceeded.
Pharmaceutical Solution · DBIZ

Digitalize the GMP-compliant pharmaceutical industry with DBIZ.

DBIZ experts provide free consultation and design the solution that best fits your business.

Free 30-day Trial Contact for consultation →
Free assessment · phased implementation · support after go-live.