The Deadline Has Passed: 6 Benchmarks for Grading Your DSCSA Performance
Back in May, we shared six milestones to help pharma companies evaluate their progress while working towards the November DSCSA serialization deadline. Now that November is behind us, many pharma companies are live and in production, sharing the required serialization data with their trade partners. But others are still in the early stages of implementing their serialization solution, or they are experiencing costly delays and “scope creep.”
Compare your progress against six key benchmarks to understand exactly where your company stands as you head into 2018.
You are shipping serialized product.
Serialization is your license to sell. If you are shipping product that is not serialized—and is not exempt based on grandfathering guidance—then you are out of compliance. And remember, regardless of the FDA’s enforcement discretion, the law is still in effect.
T3 documentation is digitized.
Are you providing transaction information, transaction history, and transaction statement (T3) electronically, and in the formats preferred by your partners? That was another stipulation of the 2017 requirements.
Your CMOs are onboarded—and you’re exchanging data with them.
If not, how much longer is it going to take you to get there?
If you’re still using a solution built on single-tenant architecture, you’re looking at 45 days or longer to integrate with every single CMO—often at a cost of more than $65,000 per integration—before you can ship serialized product.
Your solution is validated.
To meet a “high degree of assurance” that you are operating in a validated state as defined by the FDA, your serialization solution must be validated. Have you successfully completed the IQ, OQ, and PQ? And as regulatory and business changes demand updates and further validation, will you be able to validate again without sapping staff and budgetary resources?
Your system integrations are far behind you.
Your new line equipment deployments should have happened long ago. Are endless customizations and a lack of out-of-the-box functionality slowing you down?
You have laid a foundation to serialize in all your trade markets.
If you sell product in any country outside the U.S. that has emerging or existing regulations, your serialization platform should be capable of meeting all your global requirements. For many companies, EU FMD is up next. Is your solution provider a certified OBP connection partner with a proven track record of uploading data to the EU hub?
Is it time to get on track with a proven serialization-ready partner?
From a readiness standpoint, serialization solution providers need to adhere to standards as well. TraceLink helped more serialization customers to be ready at the November 27 serialization deadline than any other solution provider. Contact us to learn more at firstname.lastname@example.org.