BLUE Software
Managing Label Complexity and Demand for Agility for Pharmaceuticals

Evidence of globalization on the pharmaceutical landscape can be measured by the increasing complexity of R&D, innovation, and technology-related investments. Though labeling information is typically accurate, even infrequent and minor errors can cause launch delays, recalls and noncompliance “483” letters. To minimize these obstacles, pharmaceutical firms are adopting brand lifecycle management software to improve packaging accuracy and marketplace agility. “Today, while a pharmaceutical firm is designing a drug and pursuing regulatory approvals and drug patents, they are simultaneously creating packaging and graphics as the information about the product evolves, while also complying with the in-destination regulatory requirements. They rely onsecure, real-time sharing of critical product information,” remarks Stephen Kaufman, Chief Product Officer, BLUE Software.

The Chicago, IL, based BLUE has made its presence felt in the pharmaceutical market with its global brand lifecycle management software as a cloud-based offering. The broad range of services offered by BLUE revolves around labeling and artwork approvals management, compliance, and analytics-based reporting capabilities that cater to a variety of verticals including the pharmaceutical sector. With a blue-chip client base that manages tens of thousands of brands using its software, BLUE’s modules have been deployed across various geographies and are delivered as a stack application that gives its customers a single point system of record for the entire workflow.

BLUE’s ability to securely integrate the development, approval and distribution of graphics through cloud-based technology provides agility as pharmaceutical companies move into global markets execute more frequent mergers and acquisitions. More and more pharma companies are leveraging software solutions to help deliver the information shoppers want, whether that’s through SmartLabelsTM on an iPhone or rich media experiences in online shopping environments. “The package is the most complex communications vehicle, with an average of 30 unique data points for pharma products, yet the pace with which this information changes is ever-increasing,” says Kaufman. “This demands a high level of agility from product manufacturers.”

BLUE helps pharma companies gain confidence that their labeling information is 100 percent accurate every time.

The package is the most complex communications vehicle and managing its graphics and information demands a high level of agility from product manufacturers

“Many pharma companies accept unnecessary risk in the ‘messy middle’ between their Resource Planning software and Supply Chain software while they are creating and revising brand assets and labels,” explains Kaufman. BLUE has built their software around the vision of including graphics and labeling as part of the information continuum that includes the PLM and ERP systems. BLUE’s software has been validated at more than twelve large, global pharma companies.

“The Quality Control tools embedded in the Online Approval module allow a user to create a detailed overlay from one version to the other to highlight the differences,” states Kaufman. Pharmaceutical firms are keen on minimizing the costs associated with redesigning or re-routing the labeling process wherein the artwork gets rejected on grounds such as “out of place graphics” or lack of copyright compliance. The “Rejection Reasons Report” generated by the BLUE Business Intelligence module provides clients with metrics around a recurring issue, the rate of recurrence, and the exact percentage of their overall workflow impact. The integration with industry standard business intelligence tools allows end users to build custom reports without having to be data experts.

Over the years, BLUE has developed software that harmonizes global process with regional sensibilities, for instance, enabling companies to comply with US FDA Title 21 CFR Part 11 as well as EU Annex 1169. Having amassed the reputation of being a trusted advisor among its pharmaceutical, consumer goods, and retail clientele, BLUE has now set its sights on developing big data solutions that leverage the product data manufacturers already have. “The enterprise system of record provided by BLUE is the only solution in the pharmaceutical space that can be validated and includes highlights such as a single point of entry and virtually no scope for errors,” concludes Kaufman.