"Anything we can do to protect the drug pack without changing the look of it is high on my priority list because additions and changes can require regulatory approval."

Caleb Connell, AD, Global Animal Health Technology Lifecycle Management

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Customer

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Challenge

Poised with significant business risks, Boehringer Ingelheim was faced with the dilemma of having to replace its incumbent serialization vendor at three of its newly acquired global manufacturing sites; one in Puerto Rico, and two in France. With a production-ready deadline of July 2019 for the change out, Boehringer Ingelheim reached out to Systech, who was already a strategic business partner for 10+ years with over 40 system installs across the Boehringer Ingelheim network, for direction on how to accomplish the objective. The drive for a fully functional solution deployed within six months was quite aggressive and forced Systech to leverage its relationships within the manufacturing site regions to be resourceful and agile in their solution strategy.

Additionally, a major obstacle for pharmaceutical serialization at these new target sites was reconciliation of batch lots. Because aggregation was completed at the end of the batch as opposed to real time, Boehringer Ingelheim had to deal with the inevitable issues around the inaccuracy of case management, such as not being able to guarantee that all products were in the correct cases.

“We are always mostly concerned with the support and ongoing oversight of the systems after a challenging deployment of any system occurs. Systech has demonstrated that they are committed to that support and to strengthening the partnership with Boehringer Ingelheim.”



Solution

Global Turnkey Solution

Because of the aggressive timeline and global nature of the deployments, Systech turned to its trusted partner network to help provide turnkey services and implementation. For the Barceloneta Puerto Rico site, Systech turned to Ultimate Solutions of Puerto Rico, and for the Toulouse and Lentilly France sites, they tapped Inno4Life of the Netherlands. Both partners provided “serialization ready” equipment with Systech’s software already installed and integrated. This eliminated the need for additional integration consultants and sped up the delivery and installations.

Reconciliation Issues Alleviated

As opposed to completing aggregation at the end of a batch as the previous vendor’s solution did, Systech’s serialization solution assigns carton numbers to the case serial number on the fly, eliminating the inevitable reconciliation issues that the three sites had been experiencing. Systech’s real-time aggregation also alleviated the serious processing and system delays experienced at the end of a batch.

An additional feature that was not a requirement but proved to be highly favorable with Boehringer Ingelheim was post-lot rework. Systech’s solution allows for real-time updates to the Level 3 aggregation structure, enabling changes to be made to existing case assignments as needed.

Standardized Deployments

Boehringer Ingelheim wanted to ensure that the three pharmaceutical manufacturing sites were as similar as possible with standardized processes and procedures. Because Systech took a centralized approach to driving the deployments with preferred partners, they were able to deliver a holistic solution across all three sites, despite deploying different equipment from the two partners. Unlike other offerings, the Systech solution is not customized. It’s a flexible platform that can be configured—NOT coded—to align with customer-specific needs.

Results

All three sites were fully validated and in full production within six months, meeting the July deadline on time. The Boehringer Ingelheim deployment team noted that Systech had ultimately met and exceeded all expectations for deployment at the three sites. 

Next Steps

Boehringer Ingelheim values Systech as its partner in traceability, supply chain security and brand protection. The company is now looking at Systech’s broader portfolio of solutions to help ensure that their products are authentic, safe and connected across the supply chain. After deploying Systech’s serialization solution, all three sites are ready for UniSecure®, Systech’s revolutionary authentication solution.

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