Image is the icon of SCW.AI's Digital Batch Record.

GMP Compliant Solution for Improving Corporate Compliance

Soon to be Released

Digital Batch Record is an emerging paperless manufacturing solution within the Digital Factory Platform, designed for the pharmaceutical, food and beverage, and cosmetics industries. It ensures compliance with cGMP regulations, enabling manufacturers to collect, monitor, and analyze data in line with FDA and EMA standards.

By design, Digital Batch Record adheres to ALCOA+ data integrity principles, offering features such as:

  • Verified user authentication
  • Built-in document management system
  • Defined approval workflows
  • Automatic calculations and conditional process flows
  • Real-time notifications for out-of-specification and out-of-trend events and many more.
Image shows the Digital Batch Record Module of Digital Factory Platform that designed for pharma manufacturers to improve compliance.
Image shows capabilities of Digital Batch Record.

Top Use Cases of Digital Batch Record

  • Reduced Risk of Receiving FDA Warning Letters: In 2023, the FDA issued 1,383 warning letters, 83 of which could have been addressed by Digital Batch Record since they were related to non-compliance with FDA 21 CFR Part 11 articles about batch recording.
  • Improved Production Excellence: Workflow checklists help operators follow SOPs, reducing quality losses and improving Overall Equipment Effectiveness (OEE).
  • Less Time on Non-Value-Added Tasks: Digitizing forms cuts data entry time by 50% to 85% compared to legacy paper-based systems.
  • Faster Cycle Time: Legacy batch record systems lack real-time notifications, causing delays in document approval that can halt production lines and complicate work order management.
  • Reduced Financial and Environmental Costs: Switching from paper to digital records lowers both financial and environmental expenses.

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Image shows the Digital Batch Record Module of Digital Factory Platform that designed for pharma manufacturers to improve compliance.

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