Some common question we hear from potential and new clients:

Don't wait till it is too late to have a full understanding of your DSCSA coverage and risk discovering you missed the things that a state or federal inspector will check first. Rather than rushing to install a solution, as with any system implementation, you should make sure you understand what your specific scenario requires. There are many surprises and areas for confusion in DSCSA implementation.

As some examples, here are a few common gaps we have come across as we help our clients get a more complete picture of DSCSA readiness:

• Procedures do not sufficiently document DSCSA requirements coverage
• Employee training records for DSCSA related procedures are not up to date
• Your organization needs to cover requirements for multiple DSCSA roles based (manufacturer, repackager, distributor, dispenser, 3PL)
• Combination drug/device products may require UDI and/or DSCSA labeling
• Not ready to receive product electronic verification requests  (as some dispensers have indicated they are planning in receipt)
• Have not planned for increased emails and phone calls to support likely early volume of exceptions
• No clear process for receiving and responding to product tracing requests when required
• Trading partners (direct/indirect) are not checked for valid license and/or registration
• Unclear source of truth and ownership on storage of related data

We have seen DSCSA stakeholders complete large DSCSA projects, only to discover that they missed major components and need to start a new project. A full assessment of DSCSA requires understanding the law, FDA guidances, industry standards and knowing when your trading partners are expecting you to support them.

We offer a free consultation session and are proud to say that our assessments have been audited by a large outside firm and not only passed but helped them improve their own assessments.

The results of our DSCSA assessments, can be used to inform your leadership, make sure you are ready for regulatory requirements, and more accurately plan your budgets.

Contact us to discuss more at info@tencountconsulting.com

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