Original Data: entry of process values into BatchLine
As above for Data Integrity there is a requirement that the Original Data is ensured. In EBR, data can be entered manually such as for equipment set up where machine parameters can be entered and BatchLine checks the entries against the specified pre-set values. The following examples highlight where manually entered data collected in EBR are an improvement over typical paper batch record controls:
Case studies show that standalone EBR typically reduces the overall number of manual data entries in a batch record by 50%.
It is also possible to integrate data directly from equipment to the EBR, this adds a level of complexity and cost for the technical interfacing, however can further reduce the need to transcribe data into an EBR, especially those values that are classed as a Critical Process Parameter may be considered.
When starting an EBR deployment we recommend that you perform and document a risk assessment of the data flow to justify the way the data is collected. The assessment should also consider the alarm, summary records, and audit trails. Critical alarms and any changes to critical settings have to be recorded. Simply put, EBR can manage these important data recording tasks without paper, and brings many ALCOA improvements simply by using its basic functionality.
Check out the next chapter
BatchLine Resources, GMP aspects of EBR, case study GBP