Creation

  • Values from sensors have metadata (range, units, tag, calibration, etc.) applied
  • Values communicated from other systems have metadata applied
  • Values captured from operator (with metadata stored to audit trail)

Processing

  • Calculated values
  • Comparison of actual and desired values to produce alarms and events
  • Temporary local storage to UHH files on recording device

Storage

  • UHH files can be stored within the recording device
  • UHH files can also be transferred to a storage location

Review, reporting and use

  • Recorder screens show current values, current alarms, trended values, historical alarms
  • Historical data values and alarms can be used for review (Data Reviewer software) or reporting (Dream Report software) and GxP activities

Retention and retrieval

  • UHH files enable retrieval of electronic batch data for investigation

Destruction

  • Removal from archive location and destruction of data at end of required retention period

To discuss your data integrity needs: