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A global generic pharmaceutical manufacturing company with products in therapeutic areas like Cardiology, HIV, Oncology, Gynaecology, Diabetes, Nephrology and Analgesics, selling their products in more than 70 countries, had embarked upon a digitization exercise for their manufacturing operation.

The existing operation was completely paper based, which led to challenges in management of MBRs, making usage decisions, synchronization of inventory with SAP, and creating regulatory compliance reports and audit trail.

The Solution

The customer selected Performix xMES solution for the complete digitization of their Batch Process Manufacturing. The solution consisted of components for digitizing their weigh and dispense procedures and production MBRs, and executing the procedures and MBRs on the shop floor using handheld devices

Key Features Deployed

Weigh & Dispense

  • Multiple Weigh Methods
  • Calibration Procedures
  • Potency Calculations
  • Integration with Scales
  • Integration with SAP S4/HANA
  • 21 CFR Part 11 Compliant
  • Standard Reports

Manufacturing Batch Record (MBR)

  • Operation and Phase templates to enforce standardization and re- usability
  • Work flow engine for approvals
  • Leveraged SAP Master Data

Manufacturing (EBR)

  • 21 CFR Part 11 Compliant with complete audit trail
  • Electronic work instructions using intuitive touch screen UI
  • Standardized Phase and Operation libraries
  • Generated EBR
  • Integration with PLC/SCADA, Document Management, CAPA
  • E-Logbooks
  • Enabled Batch review by exception
Value delivered
  • Compliant solution for complete Batch Process Manufacturing - Weigh & Dispense, Master Batch Record, Electronic Batch Records
  • Enabling paperless execution of all manufacturing processes
  • Enforces data integrity, and adheres to 21 CFR Part 11 compliant
  • Out of the box integration with SAP ECC and S/4HANA – unlocks additional value from SAP investment
  • Provided Rich visualization and intuitive user interface – Ease of operation for plant personnel
  • Small footprint and minimal configuration