95 | Ability to view material information for a batch/lot in an App. Information includes all material as part of a material hierarchy, ie. cohort, plate, well, etc.) |
127 | Disallow completion of work until all required processing steps have been performed. i.e. disallow batch close when there are incomplete processing steps. |
197 | Ability to collaborate on definition of models including ability to simultaneously author/change model definition for equipment, material and production. |
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. |
289 | Ability to exclude a work order from the dispatch list. |
295 | Verify that all required data has been entered and collected as prescribed by the step on completion. Disallow to progress on execution path if verification fails |
326 | Ability to route and disposition materials based on sampling plans Eg. hold or future hold materials until sample testing results are available |
327 | Ability to route and disposition materials based on results of sample testing (off-line) and/or quality testing (in-line) Eg. hold, reject, scrap, or release materials based on sample result |
329 | Verify entered data is within configured limit and tolerances as configured in the Master Recipe or material workflow process step, and material model. Allow authorized override of this constraint based on configuration |
330 | Ability to automatically or manually log an exception when data is not within configured limits and tolerances. Disallow process completion until exceptions have been logged with configured e-signatures and any authorized overrides have been processed e.g. supervisor signature, scrap, etc. |
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. |
388 | Ability to track material inventory and its physical location. |
390 | Ability to track materials associations using the material tracking model. Ie. track physical material in tray location, trays in batches (Cohorts). |
392 | Ability to track materials handled in load-carriers. |
393 | Ability to track loading of material to a load-carrier and its location within the load carrier. Ie. material in a well, plate, flask, tank, tote, etc. |
394 | Ability to track unloading of material from a load-carrier |
406 | Ability to consume by pre-configured unit of measure (UoM) quantities such as weight, volume, etc. |
427 | Ability to track material attributes during production operations with associated capabilities to browse their history and their trending e.g. temperature, assays, etc. |
457 | Ability to define work order types to indicate special processing or release procedures. Ie normal, testing, prototype, validation, rush, etc. |
848 | The ability to discern invalid or altered records. Ability to annotate data is changed. For GMP or critical data changes annotation can be configured as required. |
900 | Equipment & cleaning log - The system must be able to create logs for registration of use, maintenance, calibration & cleaning of equipment and rooms. |