“Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate”
I have been discussing this with a colleague and we interpret it differently. I am of the opinion that the SOP will indicate operational system checks and this will be configured in the software.
So, pre-defined messages can be configured to prompt an operator, supervisor, manager or QP to enter data. The SOP will instruct on this and the software will only allow a certain order to the steps.
The QP would not be able to sign off a batch electronically unless all previous steps from operators, supervisors and managers were completed (if this is how it was configured).
Operator to add X to container Y - prompted on screen to add, has to complete box with weight and sign
Supervisor prompted to check, enters yes and signs to confirm review
Manager prompted to authorise, enters comments and signs
QP to prompted to approve and the batch and it will not be marked as acceptable until this final signature is entered.
My colleague interprets operational system checks from a purely software perspective in that the actual software design includes system checks internally.
Any comments are much appreciated.