In its two April sessions, TraceLink’s China Special Interest Group (SIG) revealed TraceLink’s new Community web pages and continued its discussions around top challenges, recall choreographies, and whether or not temperature data needs to be provided to China’s National Medical Products Administration (NMPA) Collaborative Service Platform. The April 6 session provided a step-by-step overview of TraceLink’s implementation roadmap for China compliance customers, while the April 20 session offered new insights into TraceLink’s Opus Digital Network Platform and how it will accelerate the development of TraceLink’s track and trace solutions.
The Customer Community Information Section on TraceLink.com
With the launch of the redesigned TraceLink website, community members now have a dedicated section where they can explore groups, request membership, and see the calendar of upcoming sessions. The section features salient topics from the current Special Interest Groups and Innovation Forums as well as information on existing and upcoming User Groups and Expert Forums. Explore the new online community pages.
Poll results: Top China challenges
Regular polling is a key component in shaping the discussion topics and agendas for TraceLink’s Special Interest Groups and Product Innovation Forums, as well as providing valuable insights for the TraceLink product development team. The community poll of “hot topics” taken March 23 revealed customer concerns on both the compliance and business sides of their operations, including:
- Meeting downstream data exchange requirements
- Aligning plans among global operations, affiliates, and partners
- Determining a China product coding approach
- Managing intermediate deadlines
- Transitioning between legacy and current reports
- Mapping product importation flows
Mapping the path to China compliance
The April 6 SIG was joined by TraceLink’s April Fitzgerald, Director of Client Partnership for Supply Chain Distribution and Manufacturing, who provided an update of where customers should be at this point in their China compliance planning. As we approach the design phase of the compliance journey, group discussions are focused on defining and prioritizing use cases in advance of the solution development stage:
- Stage 1. Mandate Awareness
- Stage 2. Proactive Monitoring of Regulations and Guidelines
- Stage 3. Compliance Solution Design
- Stage 4. Compliance Solution Development and Testing
- Stage 5. Compliance Solution Deployment and Acceptance
- Stage 6. Compliance Solution Maturity
Two use cases that continue to generate group discussions are recall reporting and providing temperature data to the NMPA’s Collaborative Services Platform. The group analyzed several possible—and yet to be confirmed—recall sequences: the business process, the TraceLink event it triggers, the reportable step, and the appropriate reporting entity. The group also examined the possibility that temperature information for cold chains may need to be accounted for in reporting, although it is not currently identified as a data set that must be provided to the NMPA.
TraceLink’s Opus platform and product roadmap webinar
On April 20, TraceLink introduced Opus: a digital supply network creation platform that provides a low-code environment for developing multienterprise applications. For TraceLink customers, Opus promises to drastically reduce the software development lifecycle and help them quickly meet new and evolving compliance mandates and deliver products to global markets faster. SIG attendees received exclusive access to an invitation-only webinar that provided a comprehensive overview of Opus and TraceLink’s 2021 product roadmap.
Stay informed with TraceLink’s China Special Interest Group
As 2021 unfolds, TraceLink's China Special Interest Group will continue to be the dedicated space for TraceLink customers to share interpretations of regulatory requirements; discuss the business challenges they create and how fellow members are meeting them; and get updates on TraceLink’s track and trace solutions. Join the TraceLink Community.