Aggregation machine

Kindly provided by guidance or templates or the correct way to make the aggregation machine qualified note that I don’t have any related documentation for the machine.

  1. you have to Qualify the equipment’s DQ,IQ,OQ, and PQ received for Aggregation.
  2. Parallelly you have to validate the software.
  3. Select the Product as per Box dimensions.
    4.reffer the GS1 guidelines for GTIN numbers for sterilization and aggregation.
  4. Please make sure that you are following the SSCC codes or Serial numbers for pallet level aggregation.
    6.Software should comply with 21CFR part11.
  5. make sure the posting of data to server, either by Tracelink or software provider.
  6. Confirm that your data is posting to local regulatory body.
  7. Revise the operating procedure and Batch records accordingly