With regulatory compliance timelines looming in every corner of the world, pharmaceutical organizations must objectively assess their compliance readiness now. While time is of the essence, your organization needs to quickly and carefully evaluate the systems, partners and technologies that will help you achieve compliance – faster, easier and done correctly. This webinar’s panel of pharma serialization subject matter experts cover:
You’ll learn why it’s important to understand the content of the data that will be exchanged with trading partners (e.g., tracking-event data, type of identifiers, required master data), as well as the mechanisms that will be used to transmit or receive data. We’ll review what the basic four dimensions for critical data tracking events are; how connections are made between trading partners; and why standard messaging formats, specifically GS1’s EPCIS 1.2, are critical for faster, easier data exchange. Finally – and perhaps most importantly – we’ll give you tips to tell whether a serialization vendor really has the necessary universal connectivity for seamless, painless partner integrations.
Validation is an important step that includes installation, testing, protocol execution, and documentation approvals. When done well, validation can help the implementation process to go smoothly. Conversely, it can cause major disruptions to your business if your solution provider’s process is flawed. We’ll share key questions to ask your serialization vendors, like what is the re-verification process if there are software updates?
A key element to the success of your serialization project is having the right support team in place. You should not only consider whether a vendor’s solution meets all of your data and technical requirements, but also whether the vendor itself is a good business fit. Does the vendor have the capacity to support your company adequately? What project management experience does the vendor have supporting serialization for companies comparable in size, geography and type of business? What will be the total cost of ownership for the serialization solution – is ongoing support a hidden cost? Finally, if you feel you’ve selected the wrong vendor and need to switch to a different vendor, is that possible and what will the process be for transferring data and cutting over operations?
Wherever you are in your DSCSA or FMD preparedness, this webinar provides practical tips not only for quick, pain-free implementation as you’re assessing your compliance readiness today, but will also help you lay a solid foundation for your serialized workflow that will provide benefits for many years to come.