PHARMACEUTICAL MANUFACTURING COMPANY SOFTWARE
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Why Choose Our Pharmaceutical Manufacturing Software?
Ensure regulatory compliance, streamline production, and maintain end-to-end quality with our advanced pharma manufacturing software built for global standards.
Regulatory Compliance
Built-in support for FDA 21 CFR Part 11, GMP, and GAMP 5 to meet strict global standards.
Quality & Traceability
End-to-end batch monitoring, electronic records, and complete audit trails for accuracy.
Efficiency & Cost Control
Optimize resources, reduce waste, and cut production costs with real-time insights.
Core Features
Our comprehensive pharmaceutical manufacturing software provides all the tools you need to streamline operations, ensure compliance, and maintain quality.
Batch Production Management
- Batch scheduling & planning
- Recipe/Formula management
- Multi-stage production workflows
- Real-time batch status tracking
Quality Control (QC) & Quality Assurance (QA)
- In-process & final product testing
- Stability testing management
- Non-conformance (NC) handling
- Documented SOP compliance
Regulatory Compliance Management
- FDA 21 CFR Part 11 compliance
- GMP (Good Manufacturing Practices)
- GAMP 5 standards
- Validation & audit trails
Inventory & Material Management
- Raw material & finished goods tracking
- Barcode/RFID integration
- Lot & expiry date tracking
- Quarantine & approval workflows
Manufacturing Execution System (MES)
- Work order management
- Equipment utilization tracking
- Real-time production monitoring
- Resource allocation
Electronic Batch Records (EBR)
- Digital batch documentation
- Automated data capture from equipment
- Electronic signatures for approvals
- Audit-ready reports
Formulation & Recipe Management
- Standardized formulas for medicines
- Revision control & version history
- Scaling for different batch sizes
- Cost calculation per formulation
Supply Chain Management (SCM)
- Vendor & supplier management
- Purchase planning
- Demand forecasting
- Cold chain tracking (temperature-sensitive drugs)
Laboratory Information Management System (LIMS) Integration
- Sample testing management
- Analytical instrument integration
- Results storage & traceability
Document Management System (DMS)
- Centralized SOP & policy documents
- Controlled access & versioning
- Regulatory submission-ready docs
Equipment & Maintenance Management
- Preventive maintenance scheduling
- Calibration tracking
- Equipment validation records
Pharmacovigilance & Traceability
- Serialization & track-and-trace
- Adverse event reporting
- Recall management
Finance & Costing
- Cost per batch/medicine
- Integrated accounting
- GST/VAT compliance
Analytics & Reporting
- Production efficiency dashboards
- Yield variance analysis
- Compliance reports
- Custom BI (Business Intelligence)
Multi-Currency & Multi-Language Support
- For global pharma companies
Mobile & Cloud Access
- Remote monitoring of production
- Cloud-based document storage
Security & Audit Control
- Role-based access control (RBAC)
- Data encryption
- Digital audit trails
Training & Support
- Role-based training modules
- 24/7 technical support
- Regular software updates
- User community & knowledge base