Master Class

Essential Reporting Knowledge

Electronic Batch Record

Summary

The ‘Electronic Batch Record’ report can be used to generate a report compliant with ’21 CFR Part 11′ regulations for electronic documentation and electronic signatures for batch/product creation.

Report Setup

This report can be found under the ‘Lists’ header in the Jasper Reports suite, and if we select it we will see the following options for running it.

 

Here we can filter batches by a specific formula, and/or select our desired batch from the searchable ‘Batch Number’ drop-down menu.

After this we have various options on what electronic records to display in the report. We can choose to show or hide:

  • Electronic signatures from any supervisor signoff events.
  • Submix composition(s).
  • Any Q&A events & responses.
  • Commodity, overhead & labor costs.
  • Any images linked to commodity suppliers and/or supplier lots from the receiving process.
  • Charts showing the breakdown of ingredients.
  • Supplier lot details (supplier name & lot number(s))

We can also choose whether to display event (batching/production) order by ‘Date & Time’ or the ‘Formula Step Sequence’ set in Control Center.

Sample Report

This report can feature different pages (or not) depending on the filter settings set when it is run. If we run the report as we have set it up in the image above, we will generate one that looks like this. Note that this can potentially be spread over several pages depending on the filter options selected above.

 

Links To

Several different reports can be accessed through this report:

  • Clicking the formula code in the top left of the report will open a ‘Formula List‘ report.
  • Clicking the batch number in the top left of the report will open a ‘Forward Traceability’ report for that batch.
  • Clicking the job number in the top left will open a ‘Job Batches’ report for that job.
  • Clicking the lot# or supplier lot# in the formula step area will open a ‘Forward Traceability’ report for that lot.
Was this page helpful?
YesNo