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