SYSTEMATIX Product Data Tracking


Without point of use information at the unit level, product holds and recalls can be a nightmare to reconcile and put quarantine efforts in place. The conventional method is to review and translate batch record information with batch quality data.  The key requirements include:

  • Solution integrated in manufacturing operation
  • Data must be readable and retrievable
  • In line product test data must be collected and stored
  • Validated and compliant to all standards including 21 CFR Part 11

Solution Delivered

Product Data Tracking

  • Validated data software to archive product specific information
  • Unique identifier written to 2D code and applied to product
  • Various analytical and digital gauges and instruments providing quality test data

Technologies Used

  • SPMX Data Matrix software package
  • Signature Analysis tools including pressure decay
  • MAVIX vision inspection of all critical quality parameters

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