The maintenance of materials status at point of use is critical for life science companies to ensure product quality pursuant to cGMP requirement outlined in 21 CFR 211.84 and 21 CFR 820.70 (h) and other guidance documents. Integration with SAP for material quality status checks during dispensing operations (or for that matter any material transaction) provides real-time quality checks at material point of use. However, what happens in the event communication between SAP and Syncade is interrupted?
The following flowchart provides the logic that we developed at a customer site for checking material status during dispensing operations and provides for the escalation to Supervisors and Quality Assurance in the event the interface and SAP itself is not available. The solution required the additional to two additional statuses to Syncade
1) SAP Status UNK – Materials would be automatically updated to SAP Status UNK if the SAP interface was down, and
2) SAP Status OK – Materials would be manually updated to SAP Status OK if the operator was able to confirm the material status manually.
This is just one of many ways that a third party application interface can be handled when it’s not available and hopefully provides some insights on how it’s been addressed in the past. A similar flowchart can be applied to any number of other material transactions such as material charges, materials used in cleaning operations, and material transfers or for equipment checks that are integrated with a CMMS system.
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