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