Record containing all quality-relevant planned and actual data on the production of a batch.

Batch records are stored in an optical archive where they cannot be forged and are approved using one or more digital signatures. They comply with international standards for processing records defined in the guidelines on Good Manufacturing Practices (GMP) for the pharmaceutical industry.

A batch record consists of a currently valid version and possibly a history. The history documents older versions that have become invalid when data was added to the batch record after it has been approved. All versions and their statuses are managed in the header record of the batch record.

At most, the batch record version can contain all of the following:

• One document for the table of contents and the version data of the batch record respectively

• One document in which the deviations that occurred during batch processing are listed
• Documents for the following R/3 objects:

• In the process order while maintaining the header data (Goods receipt tab page) or the material list (detail data on the co-product)
• At the time of the goods receipt for the process order
• While creating an inspection lot for the order
• During results recording for an inspection point or a partial lot of the order

• One document for user-defined data in which you can combine further R/3 data according to your company's requirements
• One attachment with archive files from external systems, raw data from the process control system, or labels
• The comments entered for the version
• The signatures executed during approval

Under certain circumstances, the following parts of the batch record can be left out:

• The documents for the table of contents, version data, deviation list, R/3 objects, and user-defined data

• Attachments