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  • Warehousing: Handles materials in the raw materials warehouse to finished goods warehouse. It provides for material issues with FIFO & FEFO rules.

  • Weighing & Dispensing: This ensures consistent weighing of all material types, based on recipe specification, as well as the accurate data collection required for batch tracking and documentation.

  • Master Recipe and Batch Record Management: It enables paperless manufacturing and process optimization by containing all relevant data: the master recipe, valid SOPs, detailed work instructions, workflows, and process data.

  • Electronic Master and Control Batch Record: SMART MES provides comprehensive electronic Master Batch Record (MBR) and Production Batch Record (PBR) documents, which contain all of the critical batch information from the product recipe (compiled in the MBR) and each product batch (compiled in the PBR).

    Formulation Manufacturing: Creates master record for manufacturing, capturing all the necessary details & approvals and also captures all details generated during execution.

  • Packaging: SMART MES eBR enables operators and managers to view the status of the packaging process and control the consumption, use of packaging and manufactured materials throughout the packaging process.

  • Non-conformance Management: Unexpected events impact the manufacturing process and the quality of final product. SMART MES tracks all manufacturing nonconformances caused by such things as batch material quantity changes, item substitutions, resource substitutions, as well as any ad-hoc operator observations, such as a power interruption. Notifications of nonconformances are automatically routed electronically to those who need to review and approve, including electronic signature information.

  • Batch Release & Approval: The highly reliable Batch Release & Approval module enables efficient batch release through review by exception.

    Quality Control: This application primarily deals with evaluation of quality throughout the process, right from testing raw materials, API, packaging components etc. on site before use, to testing the Drug Product at every stage of manufacturing.

    Plant Maintenance: Provides the view of operations at plant, block, line and the work centre levels. Provides for the scheduling, calibration and maintenance of various equipment.

    Process-Driven Operator Workbench: The work orders or batch records are detailed, step-by-step guides, which lead production operators through the process of making a product. The process may vary from approvals, signatures, sequential processing of steps, and specific data entry for material, resources and Quality. SMART MES provides all of the information that production operators, supervisors and schedulers need at their fingertips.

  • Production Execution and Electronic Batch Records (eBR): SMART MES makes production execution and documentation of batches simple, fast, and secure – from order management to delivery of finished drugs. In the event of a deviation, an immediately displayed alert enables timely corrective action. All process steps are documented, thus ensuring compliance with international regulations and making paperless manufacturing a reality.

  • Audit Trail & Genealogy: SMART MES records all operations for product and regulatory review purposes. It provides 21CFR Part 11 compliance, providing access control, e-signatures, audit trail, forward and backward genealogy, data security, and electronic records.

  • Manufacturing Intelligence: With its manufacturing intelligence capabilities, SMART MES has the capability to translate valuable data collected into usable information. Management can instantly view dashboards, scorecards, multi-site KPIs, and analytics to help them make appropriate decisions on a plant or corporate level.

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