ABSTRACT
There are three types of operational checks: instructions to operators, system sequencing, and Part 11 operational checks.
INSTRUCTIONS TO OPERATORS
At the operator level, the purpose of operational checks is to guide the operator during specific actions. The intention is to prevent operators from operating the system and/or signing records outside of the preestablished order. The preestablished order is specified in the system requirements specification. Two examples of typical operator actions that require the enforcement of a sequenced approach include:
• Signing a batch record to show that the addition of an ingredient occurred before the ingredient was actually added
• Verification by a second person that an activity was performed as specified by the batch record.
