QA-T380
Equipment Tracking
OBJECTIVE
Verify the following URS's:
- 168 - Ability to provide an equipment inventory list by use. Ie. material batch/lot (Cohort), Master Recipe, material workflow, equipment model, etc.
- 169 - Provide a managed way to configure and maintain a state model for an equipment, equipment group or equipment class with allowed transitions (eg. "running" and "not running" - running state; "clean", "in use", "not clean" - cleaning state)
- 185 - Ability to define quantity and capacity constraints for equipment
- 201 - Ability to define specialized equipment parameters and configuration for a process step based on assigned equipment or equipment class. Ie liquid handling and hitpick parameters or setup configuration
- 230 - Ability to define specialized equipment parameters and configuration for a process step based on assigned equipment or equipment class.
- 238 - Ability to add equipment context to historize time series data
- 242 - Ability to retrieve all historized information for a specific equipment with date-time filters
- 252 - Verify equipment is in an appropriate state to begin processing. Eg. clean, calibrated, not already in use, etc.
- 255 - Ability to verify that equipment (room, suite, area, etc.) meets routine cleaning requirements and prevent process start if cleaning status requirement is not met prior to start of processing.
- 260 - Ability to track equipment use in production execution by material unit and work order.
- 344 - Ability to track all equipment status and movement if relevant. Ie. equipment tracking history or equipment logs will contain complete history of activities performed by or on an equipment
- 345 - Track current equipment current status and state transitions. State transitions including status before and after transition will be included in the equipment history logs.
- 385 - Ability to track equipment location for mobile equipment. The equipment log will include the equipment's location history or path.
- 386 - All maintenance activities on equipment will be tracked and maintained as part of the equipment logs. i.e. calibration, PMs, repairs, etc.
- 900 - Equipment & cleaning log: The system must be able to create logs for registration of use, maintenance, calibration & cleaning of equipment and rooms.
PRECONDITION
Covers