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Electronic Batch Record Systems


Industrial Technology Systems (ITS) offers 21 CFR part 11 compliant Electronic Batch Record Systems, designed to replace manual data capture processes in pharmaceutical production facilities.

Paper-based systems are often used in the pharmaceutical sector to manually record operator actions. These systems are difficult to administer and enforce and time consuming to verify during batch approval and release processes.

Pharmaceutical manufacturers are recognising the benefits that Electronic Batch Record Systems can deliver including increases in productivity, reductions in time to market and improvements in FDA/MHRA regulatory compliance.

ITS specialises in the design and implementation of EBRS systems, developed using standard off-the-shelf products. Secure access is provided through browsers and data capture devices are used to record the data, efficiently. The systems are fully compliant with data integrity requirements and 21 CFR Part 11, the FDA’s rule for electronic records and signatures.

ITS’ Electronic Batch Record Systems automatically create/control electronic forms to record any of the following activities.

  • Work order creation
  • Component dispensing
  • Line clearance
  • Component collection
  • Production interventions
  • Production output
  • Product quality sampling
  • End of batch checks
  • Return to stock
  • Waste calculations
  • Product handover and packing

The batch reports enable the pharmaceutical sector to perform batch approval and release in a fraction of the time of original manual processes. This provides a huge reduction in the elapsed time between the creation of product and product approved release, and significant savings in the cost of work in progress. Using an Electronic Batch Record System, pharmaceutical manufacturers can significantly reduce each product’s time to market.