Pharma compliance – Manufacturing Compliance Console


Customer Requirements

  • Record all interventions
  • Establish allowable interventions during validation
  • Account number of interventions
  • Track deviations if number exceeded maxima
  • Guide operator on SOP through audio/video media

The Solution

  • Record interventions through a touch screen
  • Interventions linked to door open/close and machine start / stop events
  • Interventions classified into convenient groups
    * Infeed, filling, outfeed, sealing….
  • Online/ Offline printing of events
  • Offline analysis using trend charts, graphs

Current practice:

  • Operators find it difficult to record interventions
    * Cumbersome
    * Require paraphernalia – special stationary
    * Require scanning, transcription etc to preserve as record
  • Changes of not recording higher as a result

Benefits:

  • Record events with time stamp
  • Store batch wise reports
  • Establish legitimacy of machine stop/start
  • 21 CFR Part 11 compatible
  • Log printout can be attached to BMR
  • Use the collected data to train and counsel operators
  • Generate trend reports

Completed in December 2014