QA-T274

Process Modeling Management

OBJECTIVE
Verify the validity of the following URS's:
  • 93 - App has to provide navigation between process steps from external input. Ie. scanner, button, switch, I/O triggers, etc.
  • 118 - Ability to configure steps and states for work on orders, materials or equipment in a workflow
  • 119 - Ability to configure procedural elements for work on orders, materials or equipment in a workflow
  • 121 - Process and production model definitions shall include structures necessary for process execution, including procedural sequences with relevant process information that can guide an operator through task execution.
  • 123 - Ability to define process and material workflows structures that can be executed in sequence with one another
  • 125 - Ability to define conditions to route process between steps in the workflow. These conditions can be based on state change in other steps or time constraints, equipment status, critical alarms, completion of other steps or defined timers.
  • 127 - Disallow completion of work until all required processing steps have been performed. i.e. disallow batch close when there are incomplete processing steps.
  • 150 - Ability to define steps and procedural elements that are triggered by time-based events such as timers or date-time.
  • 151 - Ability to configure allowed overrides for steps and procedural elements. An override can be allowed for out of spec conditions and can require additional approval using e-signature
  • 190 - Ability to define a UoM and the conversion formulas and rules between UoMs
  • 253 - Disallow steps from completing until the correct material, material quantity, has been consumed or identified
  • 301 - Ability to re-execute process step respecting any constraints of the process step configuration in the process flow.
  • 302 - Ability to re-execute process step with override of constraints of the process step configuration in the Master Recipe or material workflow. In such a case an extra e-signature can be required.
  • 827 - Ability to capture data during App execution and identify the data with the version of the App that was used and its status in the workflow. ie. be able to identify if data was generated during App testing, review or approved states.
PRECONDITION
The app "Process Modeling Management" has been created.

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