Poll: 3 of 5 Companies Will Have a Level 3 This Year

Even with the volume of standardization work happening in the industry right now—in particular, OPEN-SCS—if you have a multi-line system and you’re using a line vendor’s Level 3 (L3) site server, you can be locked in by delivery schedules, procurement, and even vendor failure. What was once a simple “store and forward” functionality, the new L3 approach adds management capabilities for purchase orders, master data, serial numbers, logistics, overall equipment effectiveness, and more.

Last week over 70 webinar attendees, representing 56 life sciences supply chain companies, gathered to understand how an independent Level 3 site server standardizes global manufacturing and logistics functionality—enabling multiple line systems to “talk” to one another within a company’s serialization architecture. As part of the Level 3 Serialization Strategies session featuring Advanco, OCS, Patheon, and TraceLink, we asked attendees how their site server, IT, and infrastructure plans are evolving as the industry approaches critical DSCSA and EU FMD deadlines.

Here are the top poll findings:

1.  Three of five companies will have a Level 3 this year.

In the global marketplace, the more Level 2 (L2) line/equipment vendors an organization's architecture has, the more difficult it becomes for packaging lines to “talk” to these multiple vendors and to route requests for serialized information—one key reason many pharma companies are deploying a “vendor-agnostic” L3 solution that independently supports all line vendors.

2.  Two of three name IT integrations and negotiations with CMOs as their biggest serialization challenges.

Most serialization integrations are unique and complex, requiring a well-executed strategy for data exchange and line upgrades. L2 vendors do not have the knowledge or experience to support these complex integrations. And the risk of being locked in to a line vendor’s L3 site server adds complexity to the IT integration, artwork coordination, and pricing negotiations.

38% of respondents say managing IT integrations with their CMOs is their number one challenge right now. “Every project has its own particularities,” says Chris Howell, Global Serialization Lead for Patheon. “We preach standardization because it’s in the best interest of the industry to make things as simple as possible to get everybody onboarded.”

Negotiating who pays for line upgrades is another pain point for brands and CMOs: 28% name financial negotiations as their biggest serialization challenge. Deploying an independent L3 gives you a stronger position in the market by delivering greater availability, line negotiation power, geographic support, and insulation from vendor failure.

3.  Two of three want their serialization line hardware to be fully automated.

The preferred serialization hardware approach favors plug-and-play L2 line equipment, according to attendees: 35% prefer a fast-track solution to automate and standardize production within six weeks. Another 27% want automation that can get them ready within six months. And the rest plan to integrate with their existing third-party systems. Not surprisingly, nobody wants a manual solution for printing serialized labels.

A line vendor’s expertise focuses on the machines and line equipment that support all this automation and integration work, but their L3 solution has significant disadvantages—after all, line vendors are not experts in technology that’s needed to interface with a serialization repository and the higher-level software systems that work requires. Lack of IT experience can result in a line vendor’s site server going down, grinding your production to a halt.