New TraceLink India Compliance Module Expands Industry's Largest Family of Track and Trace Solutions
TraceLink Inc., the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, announced the general availability of its India Compliance module—new software that allows any pharmaceutical manufacturer to quickly meet a range of serialization, reporting and compliance requirements established by the India Directorate General of Foreign Trade (DGFT) in October 2015. TraceLink has also incorporated future workflow capabilities into the module in response to forthcoming Drug Authentication and Verification Application (DAVA) portal interfaces that are still under development, so when India makes the reporting formats available, TraceLink will configure the India Compliance module, instantly enabling all customers to generate the required outbound reports.
“One of the benefits of having the industry’s largest track and trace software development team is that we are continuously able to be first to market with the most comprehensive compliance applications—and our new India Compliance module is just the latest proof point of this industry leadership,” said Shabbir Dahod, president and CEO of TraceLink. “India is a great example of how our network-tenant platform offers customers a huge advantage. While the India regulations are well defined, DAVA officials are still working to develop some of the required interfaces. By working closely with DAVA to understand all the requirements, we’ve built future workflow capabilities on top of what customers need today. As soon as DAVA makes its new interfaces available, a single update on the Life Sciences Cloud will make the interfaces available to all of our customers instantly. Companies using other single-tenant or on premise systems will have to perform individual software updates for every business connection they have—and this introduces cost and time increases that TraceLink customers never have to experience."
India Compliance: A Complete Serialization and Compliance Solution
Purpose-built to help pharmaceutical manufacturers meet India compliance requirements for serialization and reporting that went into effect in October 2015, TraceLink’s India Compliance software leverages proven and commercially tested components of other TraceLink compliance applications for master data management, serialization workflow event triggers, and government report generation. Companies using the software will reduce the time, cost and risk associated with achieving compliance in India by taking advantage of the following capabilities:
- Defining serial number templates that utilize serialization hierarchies required by the India regulations—including the ability to create configurable templates for tertiary, secondary (including mon-carton) serial number generation;
- Generating compliant XML reports for product master data, batch pre-production, batch pre-production withdrawal, production for exempt products, and production for non-exempt products with hierarchy—for delivering XML files in the appropriate sequences and ensuring that files comply with all DAVA portal file restrictions;
- Configuring event triggers to define when XML files are generated and available for upload to the DAVA portal—including the ability to generate a bulk upload of pre-existing India product master data;
- Managing India reporting requirements from a single platform—by extending existing TraceLink reporting capabilities for other countries to accommodate India record-keeping and retrieval; and,
- Locating government reports with ease—with searches based on location, report type, product code, lot, transaction, serial number, and date range.