Electronic Batch Record Systems


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SOURCE: http://www.its-ltd.co.uk/services/electronic-batch-record-systems-64.aspx

ITS offers 21 CFR part 11 compliant Electronic Batch Record Systems, designed to replace manual data capture processes in processing, food and beverage, and pharmaceutical production plants.

Paper-based systems are often used in regulated industries to manually record all the actions performed by operators and support staff during the creation of products batches and each record is signed accordingly. These paper-based systems are difficult to administer/enforce and extremely time consuming to verify during batch approval and release processes.

Manufacturers are recognising the importance of Electronic Batch Record Systems in increasing productivity, reducing time to market and improving FDA regulatory compliance. ITS specialises in designing and implementing web-based EBRS systems, developed using standard Microsoft products, and hosted on web servers. Access is provided through Internet browsers on standard Windows’ workstations, and wireless hand-held data capture devices with integral barcode scanners are used to record the data. The systems are fully compliant with 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
  • Production interventions
  • Production output
  • Product quality sampling to ISO2859 requirements
  • End of batch checks
  • Return to stock
  • Waste calculations
  • Product handover and packing

The main business drivers for EBRS automated systems are:

  • Ease of record creation by the client
  • The systems enforce process control
  • 21 CFR Part 11 compliance

The automated capture of component movement and consumption throughout the manufacturing process, is consolidated into the batch record, listing all inputs into the manufacturing process, all movements of material through the workflow and all products generated, accounting for any waste/losses and items returned to stock. This provides the client with comprehensive mass balance reconciliation.

The batch report also lists all corrections entered during the product batch. Together these enable the customer to perform the batch approval and release process in a fraction of the time required by the original manual verification and checking of all manual entries. This provides a huge reduction in the elapsed time between the creation of product and its approved release, which provides significant savings in the cost of work in progress with a corresponding reduction in the time from order placement to the product being available for delivery to the customer.

Access to ITS’ Electronic Batch Record Systems is restricted to authorised users and enforced through a combination of username, password, group membership and permission-based access controls.

All data entry is tagged with the user’s identity and time stamped accordingly. The facility to correct user entries is provided for the relevant data items, but this requires the user to enter a change reason which is stored in a time-stamped record with the new and previous data values, and the user’s identity as per the requirements of 21 CFR Part 11.

Similarly, any direct changes to the underlying database are recorded automatically by a secure third party package to provide a full audit trail of what was changed, when and by whom.



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