Pharmaceutical industries must ensure full traceability of records, including the reason for any change and/or deviation from standard processes (e.g., manual data entry).
The Life Sciences Weighing and Dispensing module provides users with the capability to configure a list of reason codes related to the dispensing processes and select the appropriate reason code when one of the following events occurs:
Manual data entry of sub-batch number
Manual data entry of tare and net weight
Cleaning operation execution
Instrument control closure
Use of an expired sub-batch
Reject the weighed quantity
Inventory adjustment posting
A second user can change the reason code selected by a dispensing operator during the execution of a task if the second person verification is enabled.
It is also possible to configure if the reason code, in case of any change or deviation, is:
Disabled – The reason code is never needed.
Optional – The reason code can be optionally specified by the user.
Mandatory” The reason code must always be specified by the user.
Mandatory when not compliant – The reason code is required only in the case of a non-compliant event (for example, instrument control failure).
The Reason code rule is configured in the Life Sciences Weighing and Dispensing Master under File > Configuration > Other options tab.
The list of reason codes available for dispensing processes is defined in the Dispensing reason codes form in Inventory management > Setup > Dispensing reason codes > Dispensing reason codes.
It is possible to assign the Type to each dispensing reason code to identify the process where the reason code can be selected. These are: Manual data entry, Instrument control, Cleaning, Rejection, Product, and Inventory). Only reason codes assigned to a process are displayed when a change or deviation from the process itself occurs.