Success StoryHow Systech and Spherity successfully collaborate to support US Trading Partners with DSCSA compliance

Systech integrated the credentialing solution CARO in their UniTrace®, DSCSA compliance package DSCSA compliance package for Authorized Trading Partners (ATPs).

Learn more about our successful partnership in our interview with Joe Lipari, Director, Product Management, Systech.

1. Why was Systech interested in credentialing of DSCSA Authorized Trading Partners (ATP)?

In the pharmaceutical supply chain, data travels with a product. Given the complexity of supply chains involving many actors, your products might end up with a trading partner who is not necessarily your direct business partner. So, the chain of ownership is getting blurry. Systech’s purpose is to be a reliable partner to our pharmaceutical customers on their compliance journey.

Having ATP credentials in messages streamlines the product verification process, ensuring clarity about who you’re sharing information with while maintaining data privacy and security.

Plus, in the Verification Router Service (VRS), everything happens within seconds! Thus, ATP credentialing provides an efficient route to best practice compliance for our customers.

2. What challenges will your customers face if they do not use verifiable credentials?

By law, our customers have a 24-hour period to respond to a verification request. Once the request is made, the clock starts. Whether through emails or data portals, there are different ways to authenticate the requester. Some verification requests can also result in investigations and tracing activities between multiple parties, including the FDA. For that purpose, the steps taken to identify ATPs must be auditable and documented.

Additionally, internal compliance audits of our customers revealed that the GLNs do not meet DSCSA requirements to authenticate authorized trading partners.

Having a verifiable credential in the system is an efficient way to comply with the ATP requirements without adding additional manual processes and relying on publicly available GLNs. The verifiable credential is automatically part of every product verification message. It’s secure and reliably tells you who the other side is.

3. How can your customers get ATP credentials?

From our perspective, VRS and ATP Credentialing go hand in hand in achieving compliance and interoperability. It makes sense that everyone using the VRS also uses credentialing. With the tight integration of Systech and Spherity solutions, our customers can activate the Credentialing feature in their VRS - no additional commercial agreements required. All is set to go!

Based on our simple process, 60% of our VRS customers already have credentials and we aim to have 100% in the upcoming months.

4. What advice do you have for the industry during the one-year stabilization period?

In general, our motto for this year is “all gas, no brakes”. There's no reason to deviate from any plans: test, test, test. The essence of the stabilization period is to stabilize electronic systems used by the industry to comply with DSCSA requirements.