ERP for Pharmaceutical Industry
Pharma-specific ERP covering batch manufacturing, quality control, regulatory compliance, and distribution management.
What ERP does T & H Software offer for pharmaceutical manufacturers?
T & H Software provides pharma-specific ERP covering digital batch manufacturing records, quality control and QA workflows, CDSCO and Schedule M compliance documentation, FEFO inventory management, and pharma distribution management including distributor secondary sales tracking.
Pharmaceutical manufacturing is one of the most heavily regulated industries in India, with strict requirements from the CDSCO, WHO-GMP standards, and increasingly, FDA or EU GMP requirements for export-oriented units. T & H Software's pharma ERP is built around these compliance requirements, ensuring that manufacturing, quality control, and distribution processes are not just efficient but audit-ready.
Pharma ERP Capabilities
- Batch manufacturing records (BMR): Digital batch manufacturing records with step-by-step process documentation, in-process checks, and electronic sign-offs, replacing paper BMRs while maintaining regulatory acceptability.
- Quality control and QA: Specification management, COA generation, deviation management, OOS investigation workflows, and stability study tracking.
- Regulatory compliance: Schedule M compliance documentation, CDSCO-ready reports, and audit trail management.
- Inventory and expiry management: FEFO (First Expiry, First Out) stock management, quarantine handling for failed batches, and automatic expiry alerts.
- Distribution and secondary sales: Stockist and distributor management, secondary sales tracking, and distribution compliance documentation (Form 19, Form 20).
- GST and e-way bill: Pharma-specific GST rate handling and automated e-way bill generation for inter-state movement.
Frequently Asked Questions
T & H Software's pharma ERP supports electronic records and electronic signatures with audit trails consistent with 21 CFR Part 11 requirements. We recommend a formal validation exercise for FDA-regulated units, which we can support.
Yes. The BMR module generates digital batch records with complete manufacturing documentation, in-process test results, and electronic approvals, replacing paper-based BMRs while maintaining Schedule M and WHO-GMP compliance.
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