From formulation labs to surgical device production lines, from nutraceutical bottling plants to diagnostic kit assembly units - businesses in the pharmaceuticals and medical technology industry operate in highly controlled environments with zero margin for error.

This industry demands not only precision but also constant adherence to regional and international regulations. You need real-time traceability, strict version control, consistent quality management, and the ability to track each product — tablet, syringe, reagent, or wearable sensor — across its full lifecycle.

At Emipro, we specialize in ERP implementations tailored to pharmaceutical manufacturers, medical device producers, diagnostics firms, and health-tech solution providers — bringing transparency, compliance, and speed to your regulated operations.

• Batch-Level Manufacturing and Quality Control
  Whether it’s a drug formulation or a device assembly, you must manage inputs, yield, test parameters, and traceability for every production batch.
  
  
• Multiple Product Categories With Different Controls
  Pharmaceuticals, medical devices, consumables, or biotech reagents each follows distinct workflows to meet predefined standards.
  
  
• Inefficient Traceability & Recall Mechanisms
  In the event of a quality concern, most companies lack the ability to isolate impacted lots, parts, or batches quickly and confidently.
  
  
• High Volume of Change Requests
  Frequent engineering changes, labeling updates, or material substitutions across SKUs require versioning and controlled cross-functional updates.

• Tool, Machine & Asset Downtime
  Production relies heavily on equipment like autoclaves, capsule fillers, CNC systems, and sterilization tunnels - whose unplanned downtime affects compliance and output.

• Validated Batch Manufacturing with Controlled Routing
  Execute batch-wise manufacturing with pre-approved BoMs, yield expectations, critical control parameters, and step-by-step routing.

• Engineering Change & Version Control
  Manage Engineering Change Orders (ECOs) for formulations, device specs, labeling, or documentation. Track all revisions with audit logs.
  
  
• Electronic Batch Records (EBR)
  Eliminate paper trails. Capture process logs, QC results, operator validations, and digital signatures.
  
  
• Integrated Quality Control & Equipment Logs
  Define inspection protocols for raw materials, WIP, final products, and equipment calibration. Record test values and automate alerts.
  
  
• Lot & Serial Number Traceability
  Assign serial numbers to devices and lot numbers to drug batches. Enable forward and backward traceability for full audit readiness and recall precision.
  
  
• Regulatory Document Management
  Manage MSDS, COA, DoC (Declaration of Conformity), product dossiers, calibration logs, and lab testing reports — all linked to inventory or production.
  
  
• Maintenance & Calibration Management
  Schedule preventive maintenance and tool validation — especially critical for equipment like tablet presses, sterilizers, or surgical mold lines.

• Allergen, Composition, and Label Control
  Configure labeling formats, define allergen ingredients, and automate multi-language packaging content.

ERP is not just about digitization — it enables safe, efficient, and compliant operations across pharmaceuticals, biotechnology, medical devices, diagnostics, and healthcare product distribution.

• Accelerated R&D to Market
  Coordinate product innovation, prototype testing, and regulatory clearance in a unified workflow that reduces time-to-market.

• Assured Quality & Standard
  Automated validations and audit-ready documentation ensure strict adherence to healthcare device standards and industry norms.
  
  
• Global Market Expansion
  Standardized labeling, export documentation, and packaging compliance make international market entry faster and more reliable.
  
  
• End-to-End Device Lifecycle Control
  Track every device through its lifecycle — from manufacturing and warranty to service, replacement, and field support.
  
  
• Protected Intellectual Property
  Restrict access to design files, blueprints, and device specifications with layered permissions and detailed audit trails.

• Scalable, Transparent Growth
  Expand into new facilities and markets while retaining real-time visibility across quality and operational efficiency.
  

  
  

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Customer Success Stories