Healthcare Manufacturing ERP
Specialized ERP for pharmaceutical manufacturers, medical device companies, and healthcare product manufacturers with full regulatory compliance.
100%
Audit Ready
60%
Faster Batch Release
Zero
Data Integrity Issues
FlowSense Healthcare ERP addresses the stringent requirements of healthcare product manufacturing. From API production to finished dosage forms, manage your entire manufacturing lifecycle with regulatory compliance built-in.
Complete batch record management, environmental monitoring, stability testing, and validation protocols ensure your products meet the highest quality standards. Integrated LIMS and electronic batch records eliminate paper-based processes.
Built for FDA, WHO-GMP, and EU-GMP compliance with 21 CFR Part 11 electronic signatures, audit trails, and data integrity controls.
Everything you need for seamless operations
Electronic batch records with 21 CFR Part 11 compliance
ICH stability study management with automatic scheduling
IQ/OQ/PQ protocols with deviation and CAPA tracking
Clean room monitoring with alert management
Track & trace serialization for regulatory compliance
Adverse event reporting and safety data management
Connect with the tools and systems your team already uses
FDA CDER
WHO Prequalification
HL7 FHIR
LIMS
Environmental Monitoring
Serialization Systems
SAP
Oracle
Built for regulatory-ready operations
21 CFR Part 11 compliance, electronic batch records, and zero data integrity issues from day one.
Go live in 8-12 weeks with pre-configured industry templates
Machine learning models trained on your industry data for predictive insights
24/7 support with a dedicated Customer Success Manager for your account
Built-in compliance workflows keep you prepared for any regulatory audit
Everything you need to know about FlowSense Healthcare ERP
Complete EBR with master batch record templates, real-time data capture, electronic signatures per 21 CFR Part 11, and automatic deviation flagging.
Yes, FlowSense Healthcare ERP comes with IQ/OQ/PQ validation documentation, CSV compliance, and a validated infrastructure that meets FDA and WHO-GMP requirements.
ICH-compliant stability study management with automatic scheduling, condition monitoring, trend analysis, and shelf-life prediction for all registered products.
Full serialization from unit to pallet level with DSCSA, EU-FMD, and India DAVA compliance including aggregation, commissioning, and exception handling.
Real-time monitoring of clean rooms with temperature, humidity, and particle count sensors. Automatic alerts for excursions with CAPA workflow initiation.
Schedule a personalized demo and see how FlowSense Healthcare ERP can transform your operations. Our team will walk you through features specific to your industry.