QA-T273

History Records

OBJECTIVE
Verify the validity of the following URS's:
  • 25 - Material history records must include exception approval log.
  • 54 - Record confirmation of process step completion in history record.
  • 76 - Ability for apps to display relevant process and production data in either graphical format. Ie. pareto, bar graphs, pie graph
  • 77 - Ability for apps to display relevant process and production data as a metric. Ie. number, gauge, indicator etc.
  • 83 - Ability to use app to complete a process step with signature
  • 245 - All tracked information must be available for analysis
  • 246 - All tracked information must be available for reporting
  • 247 - All tracked information must be available for visualization
  • 248 - Ability to define and maintain batch record documentation for regulatory compliance (electronic batch record)
  • 259 - Ability to scan and read auto-id codes generated or used by other other systems and capture their data into the material history record.
  • 267 - All process execution activities have to be recorded in history log and include the ID of user that is performing the activity and date-time stamp
  • 292 - Ability for Apps to record completion of a process step with all related information
  • 298 - Require e-signature for exception of specific configured risk categories. Ie for high severity or high risk exception require the capture of an e-signature in the history record
  • 300 - Provide a managed and authorized way to capture (log) and document any comments or exceptions during process execution.
  • 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.
  • 347 - Ability to track all WIP materials at all material hierarchy levels including batches, lots, and materials. Ie. material tracking history will include all activities performed on materials including issue, consumption, processing, mixing, assembly, movement, transfer, etc.
  • 348 - All material tracking history will include context of the operator performing the activities
  • 350 - All material tracking history will include context of material hierarchy levels
  • 351 - All material tracking history will include date and time stamps
  • 352 - All tracking history information must be retained for historical review and analysis for a configurable retention period
  • 356 - All tracked information and logs will be available as part of material and process history records.
  • 358 - Provide configurable way to review and confirm exceptions
  • 464 - Ability to perform analysis on batch/lot and material history records. Ie query history records based on any attribute of the material
  • 831 - Ability to manage an authorized change of Digital History Record with full audit trail
PRECONDITION
The app "History Records" has been created.

The user has access to a barcode scanner.

The table "xx_demo_DigtalLogBook_Equipment" should have a record that has an ID of "log_demo" and Last Log ID of any number (preferably one not in "xx_demo_log book_latest entries").

The table "history record exceptions table" has some records filled in. Data isn't relevant.

The table "material inventory" should have an entry for "bolts" and several extra records that have references to other IDs in "Material 1" and "Material 2".

Covers

urs