SCW mentioned in Gartner Hype Cycle
for Life Science Manufacturing,
Quality and Supply Chain 2022
Supply Chain Wizard LLC is pleased to announce it has been recognized as a Track & Trace representative vendor in the 2022 Gartner Hype Cycle for Life Science Manufacturing, Quality and Supply Chain.
Supply Chain Wizard LLC is a leading consulting firm in the Life Sciences Industry with Focus on Track & Trace, Digital Transformation and Robotic Process Automation (RPA).
In preparation for the last milestone of the US DSCSA traceability law with a due date of Nov 2023, Supply Chain Wizard is engaging with many Manufacturers and Wholesalers to ensure their full compliance.
Undeniably, there is anxiousness in the pharmaceutical industry. Manufacturers who have not yet upgraded all their line equipment from serialization to aggregation capabilities are facing investment needs in terms of additional equipment, implementation and validation efforts. This is in full focus on the line upgrades with the end goal of packaging product with respective aggregated data by the November 2023 deadline.
In parallel with the line upgrades and qualification, organizations are working on enabling data exchange with their downstream partners such as large distributors and specialty pharmacies.
You might recognize yourself in this situation and have similar concerns as those we have identified in the industry. So how can we get from today to full compliance within a few months? Lets look at some lessons learned from the Serialization compliance deadline efforts.
Time is the most impactful constraint. Since many manufacturers seek to purchase manual, semi-manual or automated aggregation equipment solutions, vendors are experiencing a surge in demand. This could lead to longer lead times and technical resource capacity, thereby creating pressure on your organization as this results in limited time for the implementation.
Engage with your supply planning team to discuss line downtime requirements to retrofit the line. Does this create a need for inventory build up? Do we need a third shift in preparation? Look for alternative ways to maintain production capacity such as working with contract manufacturers and packagers to serialize and aggregate batches that would normally be done on the line. Discuss the inventory depleting strategy of non-aggregated products as well.
Diligent Project Management
Engage stakeholders from all business streams to discuss implications that line downtime might have on the supply planning, the packaging engineering, the quality team, warehouse operations and others. Discuss the roles and responsibilities in an effort to promote stewardship, integrated understanding of the law and the plan to achieve compliance.
Data connectivity testing
Take the lessons learned from building the data exchange capabilities on boarding your industry partners and apply those to downstream connectivity as well. At first, transfer of data took many iterations over several weeks, and in some cases months, to achieve successful integration. Over time, as the issues were resolved and streamlined, connectivity normalized to a week or two. The same pattern is seen now with the downstream integration. Initial testing with downstream partners is taking longer than anticipated due to unforeseen obstacles. Add to the mix, the Verification Routing Services (VRS*) required to verify sellable returns, and the various companies’ Serialization teams are very busy!
For additional detail and help with your DSCSA Track and Trace compliance journey, reach out to
Mia Van Allen – email@example.com
Link to DSCSA Law and Policies: https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies
Link to VRS: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/wholesale-distributor-verification-requirement-saleable-returned-drug-product-and-dispenser