Next DSCSA 2023 Observation- The resource crunch is officially on.
A clear impact this is having on ongoing connectivity efforts- availability and support for testing
- Vendors/partners foregoing testing all together and focus instead on monitoring initial data exchanges in production
- Resource availability across all parties (manufacturers, vendors, CMOs, 3PLs) is extremely limited or non-existent. This is especially apparent within the 3PL segment which is critical for most manufacturers to perform DSCSA T2 data exchange with customers
- I understand the intention of foregoing testing- typically in scenarios where the sending and receiving vendor systems have already connected previously. This *should* be acceptable from a technical point of view- but what gets missed completely is the range of functional testing that is needed- especially that which focuses on the exception scenarios which will be the greatest cause of supply chain distribution post November. Manufacturers, wholesalers, dispensers are creating their own problems if they accept to forego testing.
- We recently saw how much of a disaster master data is. Now we are looking at the full scope of data included in these exchanges- master data, transactional data and serialization data. The latter of which is exponentially more complex than master data- I, for one, have no belief this is all going to magically ‘work’ without testing.
What to do:
- Common theme- don’t rely solely on your vendor saying everything with partner connectivity is good because a single test was run that shows a technical exchange was completed. This nonsense that you can ‘flip a switch’ on connectivity simply doesn’t exist. Moreover, “my vendor told me so” isn’t going to hold up when you’re explaining to your CXO why a shipment is stopped or when an auditor asks you to demonstrate ‘control’ of your GxP serialization system.
- Test- Currently there are too many barriers for companies to execute efficient testing because too many companies have put themselves in a position where they are wholly reliant on their partners/vendors. For example, some 3PLs are now quoting anywhere from 2 to 10 weeks for testing support and charging thousands of dollars per test. That simply isn’t sustainable for now until November. You have to be able to perform testing yourself- even without support from partners.
- The Jennason Serialization Test Tool (https://jennason.com/solutions) is the only solution in the industry that allows you to simulate the interactions of your partners and allows you to perform testing without reliance on vendors or partners. For example, you can simulate outbound shipment messages from your 3PL which in turn triggers the serialized T2 to customers. All EPCIS varieties used by the major 3PLs (Eversana, ICS, McKesson 3PL/rXCrossroads, Cardinal 3PL, etc.) are supported in the tool.
Of all the implementation phases, testing is NOT the one to try hitting the ‘easy button’. When you don’t test, you have no excuses when issues start to occur. Put yourself in a position to be able to do SOMETHING which is always better than doing NOTHING.