Unlike generic ERPs, our solution includes pharmaceutical-specific features like electronic batch records, stability study management, regulatory reporting templates, and built-in GMP workflows that standard ERPs don't provide.
End-to-End Pharmaceutical ERP Solution
Our comprehensive ERP system is specifically designed for pharmaceutical manufacturers, combining GMP production with quality management and business operations in a single validated platform.
- Regulatory-Ready: Built-in compliance with FDA 21 CFR Part 11, EU GMP, WHO, and other global standards
- Complete Traceability: Full batch genealogy from raw materials to finished products
- Integrated Quality: QMS with deviations, CAPA, change control, and audit management
- Business Process Automation: Unified finance, inventory, and supply chain operations
- Real-time Visibility: Dashboards for production, quality metrics, and business performance
Comprehensive Pharma ERP Modules
A fully integrated solution covering all aspects of pharmaceutical manufacturing and distribution
GMP Manufacturing
Electronic batch records- Master formula control
- Equipment and facility management
- Cleaning validation
- Production scheduling
Quality Management
- Document control (SOPs, specs)
- Deviation and investigation
- CAPA management
- Stability studies
- Audit management
Business Operations
- Material requirements planning
- Vendor qualification
- Serialization & traceability
- Regulatory reporting
- Financial integration
Transform Your Pharmaceutical Operations
How our ERP solution delivers measurable results across your organization
Assured Compliance
Maintain inspection readiness with built-in GMP controls, audit trails, and electronic signatures meeting global regulatory requirements.
Reduced Compliance Costs
Cut validation costs by 40% and reduce quality documentation effort by 60% with integrated electronic systems.
Improved Efficiency
Increase manufacturing throughput by 25% with streamlined electronic batch records and paperless workflows.
Built for Pharmaceutical Regulations
Our ERP system incorporates requirements from all major regulatory bodies:
- FDA 21 CFR Part 11 (Electronic Records/Signatures)
- EU GMP Annex 11 (Computerized Systems)
- WHO GMP requirements
- PIC/S GMP guidelines
- Country-specific regulations (India GMP, TGA, etc.)
Industry-Specific Capabilities
Specialized features designed for pharmaceutical manufacturing:
- Process validation support (IQ/OQ/PQ)
- Stability study management with ICH conditions
- Cleanroom monitoring integration
- Serialization for track-and-trace compliance
- Environmental monitoring data capture
Frequently Asked Questions
Can the system handle both API and formulation manufacturing?
Yes, the ERP supports all pharmaceutical manufacturing types including API production, oral solid dosage forms, liquids, sterile products, and biologics with appropriate workflows for each.
What validation support do you provide?
We deliver a complete validation package including Validation Master Plan, User Requirements, IQ/OQ protocols, and ongoing validation support to maintain compliance throughout the system lifecycle.
How does the system support regulatory inspections?
The ERP includes inspection-ready features like instant document retrieval, configurable audit trails, electronic signature verification, and built-in reporting for common regulatory submissions.