New
Pharmaceutical Manufacturing ERP
FlowSense Pharma ERP
End-to-end ERP for pharmaceutical manufacturers, API producers, and biotech companies with FDA 21 CFR Part 11 compliance, batch genealogy, and serialization built in.
100%
Audit Ready
45%
Faster Batch Release
Zero
Data Integrity Gaps
Overview
FlowSense Pharma ERP is a purpose-built enterprise resource planning system for the pharmaceutical and life sciences industry. From raw material qualification through manufacturing, packaging, and distribution, every step is tracked with complete regulatory compliance.
The platform delivers electronic batch records with 21 CFR Part 11 compliant electronic signatures, full batch genealogy with forward and backward traceability, and integrated stability testing management per ICH guidelines. Real-time environmental monitoring, controlled substance tracking, and LIMS integration ensure your manufacturing operations meet the most stringent global regulatory requirements.
With built-in serialization for DSCSA, EU FMD, and India DAVA compliance, FlowSense Pharma ERP provides track-and-trace capability from unit to pallet level. The AI-powered yield optimization engine analyzes historical batch data to recommend optimal process parameters, reducing variability and improving first-pass quality rates across all product lines.
Designed for multi-site pharmaceutical operations, the platform supports centralized master data management, site-level production execution, and consolidated regulatory reporting. Whether you manufacture tablets, injectables, APIs, or biological products, FlowSense Pharma ERP adapts to your specific manufacturing processes while maintaining a unified compliance framework.
Key Features
Everything you need for seamless operations
Batch Genealogy
Complete forward and backward traceability from raw materials through finished goods with full audit trail
Stability Tracking
ICH-compliant stability study management with automatic scheduling, condition monitoring, and shelf-life prediction
Electronic Batch Records
Paperless batch manufacturing with 21 CFR Part 11 electronic signatures and real-time deviation capture
LIMS Integration
Integrated laboratory information management for in-process, release, and stability testing workflows
Controlled Substances
DEA and NDPS-compliant tracking of Schedule II-V substances with vault inventory and destruction logs
Serialization & Track-Trace
Unit-to-pallet serialization for DSCSA, EU FMD, and India DAVA with aggregation and exception handling
How It Works
A streamlined process from start to finish
01
Material Qualification
Raw material receipt, sampling, testing, and approved/rejected disposition with vendor qualification tracking
02
Batch Manufacturing
Electronic batch record execution with in-process checks, environmental monitoring, and real-time deviation capture
03
Quality Release
Comprehensive QC testing, stability enrollment, CoA generation, and QA review with electronic approval
04
Serialization & Dispatch
Unit-level serialization, aggregation, and verified dispatch with full track-and-trace documentation
Trusted by 80+ Pharma Companies
Compliance-First Pharma Manufacturing
From API synthesis to finished dosage dispatch — pharmaceutical manufacturers trust FlowSense for FDA-ready batch records and zero data integrity gaps.
Real-World Use Cases
See how businesses leverage FlowSense Pharma ERP
Tablet & Capsule Manufacturing
End-to-end batch management from granulation through compression, coating, and packaging with in-process quality checks at every stage and automatic yield reconciliation.
Highlights
- FDA 21 CFR Part 11 compliant
- WHO-GMP and CDSCO ready
- MHRA and EU FMD serialization
- DSCSA track-and-trace built in
- AI-powered yield optimization
- Multi-site regulatory consolidation
Pharma-Grade Precision
Engineered for GMP-compliant manufacturing
Industries Served
PharmaceuticalsAPI ManufacturingBiotechNutraceuticalsMedical Devices
Compliance & Certifications
FDA 21 CFR Part 11
WHO-GMP
CDSCO
MHRA
EU FMD
DSCSA
Implementation Timeline
Typical go-live in 14-18 weeks with our proven implementation methodology, pre-configured industry templates, and dedicated project team.
“
“FlowSense Pharma ERP eliminated our paper batch records completely. FDA audit prep that used to take 3 weeks now takes 4 days. Batch release time dropped by 50%.”
Dr. Meera Kapoor
VP Quality Assurance, Aurobindo Pharma
Frequently Asked Questions
Everything you need to know about FlowSense Pharma ERP
Fully compliant with electronic signatures, complete audit trails, user authentication, data integrity controls, and system validation documentation. The platform has been successfully inspected by FDA, WHO, and MHRA auditors.
Every batch is traced from raw material receipt through each manufacturing step to finished goods. Forward traceability shows which finished products contain a specific raw material lot, while backward traceability identifies all inputs for any given batch.
Yes, full DEA and NDPS compliance with vault-level inventory tracking, two-person verification for dispensing, destruction logs, and automated regulatory reporting for Schedule II-V substances.
Built-in support for DSCSA (US), EU FMD, India DAVA, and other regional serialization mandates with unit-to-pallet aggregation, exception handling, and verification portal for trading partners.
ICH-compliant stability study management with automatic pull scheduling, condition monitoring (temperature, humidity, light), trend analysis, shelf-life prediction, and automated deviation alerts for out-of-specification results.
Related Manufacturing Products
Ready to Get Started with FlowSense Pharma ERP?
Schedule a personalized demo and see how FlowSense Pharma ERP can transform your operations. Our team will walk you through features specific to your industry.