Pharma ERP · GMP Compliant · Schedule M · 21 CFR Part 11

India's most complete GMP-compliant ERP.

DeepScience Tech's Pharma ERP is built on Frappe/ERPNext with deep pharmaceutical industry extensions — covering GMP compliance, batch manufacturing, quality control, LIMS integration, Schedule M documentation, and regulatory submission support for API manufacturers, formulation plants, and pharma distributors.

Why Pharma Needs a Specialist ERP

Generic ERP fails pharma. Industry-specific ERP wins.

Pharmaceutical manufacturing is one of the most regulated industries in the world. Schedule M compliance, batch genealogy, stability studies, and CAPA management cannot be bolted onto a generic ERP as an afterthought. DeepScience Tech's Pharma ERP is built pharma-first.

GMP
Ready out-of-box
Schedule M
Fully supported
NABL/ISO
Audit-ready
21 CFR
Part 11 capable
Pharma ERP Modules

Every module a pharmaceutical company needs.

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Batch Manufacturing (BMR/BPR)

Electronic Batch Manufacturing Records, Batch Processing Records, in-process quality checks, batch yield calculation, line clearance, and batch genealogy from RM to FG.

Quality Management (QC/QA)

Sampling plans, COA generation, stability studies, out-of-specification (OOS) investigations, change control, CAPA, deviation management, and product recall management.

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LIMS Integration

Seamless integration with laboratory information management systems — test results auto-populate from lab instruments, reducing manual entry and transcription errors.

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Regulatory Documentation

Schedule M compliance documentation, MHRA, USFDA, and WHO-GMP ready electronic records. 21 CFR Part 11 compliant audit trails for all data changes.

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Inventory & Expiry Management

Lot-controlled inventory with expiry date tracking, FEFO (First Expiry First Out) picking, quarantine management, and auto-hold on expired or rejected lots.

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Production Planning (MRP)

Material requirements planning for API and formulation, campaign scheduling, capacity planning, and vendor-managed inventory for critical raw materials.

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Formulation Management

Master Formula Records, Bill of Materials for each SKU with active ingredient percentages, excipient ratios, packaging specifications, and artwork management.

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Regulatory Submissions

COPP (Certificate of Pharmaceutical Product), dossier management, product registration tracking, and market authorisation document version control.

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Cost Accounting

Batch-level cost tracking, yield variance analysis, activity-based costing for manufacturing overhead, and profitability by product/SKU/customer.

Compliance Coverage

Built for every regulatory framework.

Indian Regulatory

  • Schedule M (GMP) — documentation and SOPs
  • Drugs & Cosmetics Act compliance
  • CDSCO reporting requirements
  • Indian Pharmacopoeia (IP) standards
  • NABL laboratory accreditation support
  • Drug licence management and renewal tracking

International Regulatory

  • USFDA 21 CFR Part 11 — electronic records & signatures
  • WHO-GMP compliance documentation
  • EU GMP Annex 11 for computerised systems
  • MHRA (UK) compliance readiness
  • ICH Q10 pharmaceutical quality system
  • ISO 13485 for medical device integration
Who Uses Pharma ERP

Built for every segment of the pharma value chain.

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API Manufacturers

Batch manufacturing, yield tracking, quality control, regulatory documentation, and export compliance for active pharmaceutical ingredient manufacturers.

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Formulation Plants

Tablet, capsule, liquid, and injectable manufacturing with full batch record management, in-process QC, and finished product release workflow.

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Pharma Distributors

Secondary distribution, cold chain tracking, expiry management, Schedule H/H1 narcotic register, and GST-compliant billing for pharma wholesale distributors.

Other ERP Verticals

Need ERP for a different industry?

Pharma ERPHealthcare ERPHospital ERPEducation ERPManufacturing ERPMedia ERPRetail ERPNGO / Govt ERPERPNext ServicesFrappe Development
FAQ

Common questions

Is DeepScience Tech's Pharma ERP GMP compliant out-of-the-box?
Yes. The Pharma ERP includes Schedule M-aligned electronic BMR/BPR templates, audit trail for all data changes, electronic batch release workflow, and SOD (Segregation of Duties) controls required for GMP compliance. USFDA 21 CFR Part 11 electronic signature support is available as an add-on module.
Can it replace our existing LIMS?
The Pharma ERP includes a basic LIMS module for test request, result entry, COA generation, and OOS investigation management. For labs with advanced instrumentation integration requirements, we integrate with third-party LIMS systems (LabVantage, STARLIMS, LabWare) via API.
Does it handle Schedule H and H1 narcotic drug registers?
Yes. The Pharma Distribution edition includes Schedule H, H1, and narcotic drug registers with automatic stock movement recording, balance tracking, and regulatory report generation in the format required by state drug authorities.
How long does Pharma ERP implementation take?
A typical single-site formulation plant implementation takes 12–18 weeks. API manufacturers with complex batch routing may take 20–24 weeks. We use a phased approach — core financials and inventory first, then manufacturing and QC modules.
Is GST e-invoicing supported for pharma exports?
Yes. The ERP generates GST-compliant invoices with GSTN validation, e-invoice IRN generation for B2B supplies, and export documentation including ARE-1/ARE-3 forms, shipping bill details, and IGST refund claim data.

Ready to modernise your pharma operations?

Book a demo specific to your pharma segment — API, formulation, or distribution. Our pharma ERP consultants will map your compliance requirements in the first call.