In the S88 standard of the Instrument Society of America, process data documentation and evaluation is defined as the "control activity that is involved in collecting, storing, processing, and reporting production information". In a batch-manufacturing environment, the major functions of these activities include the creation and management of batch records. This comprises two sides of information management:
- Documentation or logging of process data, which especially in strongly regulated industries such as the pharmaceutical one, requires a form that excludes manipulation
- Statistical or evaluation functions to be used, for example, for purposes of process optimization
Within the R/3 PP-PI component, you will find these activities implemented in the following functions:
- Process data documentation that enables you to store process data in an optical archive (electronic batch record / EBR)
- Various evaluation options including the
- Shop floor information system
- Process message evaluation
- Possibility of accessing both planned and actual process data on the database for evaluations using external tools