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