Process Data Documentation and Evaluation (PP-PI-PDO/PEV)
In the S88 standard of the Instrument Society of America, production information management 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 a batch history. This comprises two sides of information management:
Documentation or logging of production information, 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 component PP-PI, you will find these activities implemented in the following functions:
Process data documentation, which 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
