January 26, 2016

Device History Record

 

Device History Records are authentic copies of a Device Master Record that are use to document the specific information for an individual batch.

InstantGMP™ generates Device History Records that keep track of:

  • When a product was produced
  • Unique Batch and Production numbers
  • The quantities of raw materials and ingredients that went into a batch
  • Which lots of raw components and ingredients were used in manufacturing
  • The actual manufacturing steps that were followed and the results obtained
  • Any deviations that were investigated and resolved
  • This record includes: cover page, materials, equipment used, in process testing, manufacturing instructions, and inventory
  • Manufacturing instructions allow for the entry of step results in real-time during manufacturing and recorded by operators
  • DHR Approvers can approve or reject a DHR
  • Once a product has been manufactured, it can be added to inventory
  • The system will assign a receipt number to any WIP or Finished Good material that is added to inventory
  • DHRs can be exported as PDFs