Today, the company has developed vital links that connect BLUE with core IT systems sitting at the heart of any corporate data. Such integration allows BLUE to initiates processes and move graphic artworks throughout the organization. Also, BLUE can broadcast workflow status information to the other systems such as ERP and PLM and thereby keep the broader audience informed with real time status.

Owned by Schawk since its incorporation in 1997, BLUE has been spun off as an independent company recently. It is now wholly owned by Diversis. Products from few other acquisitions are now integrated into BLUE’s offerings. BLUE also acquired a company called Viki Solutions in Vancouver, which empowered it with an online art proofing software as well as its development team.

Revolutionizing the Labelling Industry

FDA dictates that drug labels used in the pharmaceutical and healthcare products be designed and applied in the way that they remain true in different environments through distribution, storage and use.Unwilling to take chance, pharma clients often pick older graphics and move them through the BLUE process to compare it with the original packaging and make sure labelling is absolutely identical except for the area where the information has changed. BlueSoftware’s process starts right from the time the labelling content is originally developed by the pharmaceutical company till it gets printed on the labels and distributed in the market. The process is supervised by internal graphics department or an external art agency, design firm or pre-media supplier for over a course of several weeks, and then changes are incorporated and routed for approvals. BLUE tracks this process at every stage, collects inputs, records changes and delivers real-time status updates of the process. Automated workflow takes care of the rejections and re-routings, increasing efficiency and lowering cost.

“BlueSoftware’s process starts right from the time the labelling content is originally developed by the pharmaceutical company till it gets printed on the labels and distributed in the market”

BLUE has four main components: First, the Digital Assets Library which stores tens of thousands of previously approved packaging graphics and pick them up when required. Second, the Workflow module which allows clients to build very specific and documented process with states mentioning to whom each graphic would be routed to, who has the right to reject or approve, what happens if it is rejected, how does it get looped back through and how eventually the final art work gets moved out onto the supply chain. The third module is the online approval module using which a client can pull out a very detailed high resolution presentation of the graphics and put annotations directly on it. The fourth module—Blue Reporting Module—tracks the reasons for rejections in a workflow and captures common errors like EPC code, in accurate ingredient statement or the drugs facts panel. The BLUE reporting allows not only to route the product information but also list according to the brand, product and region that is performing well with least number of approval cycles.

Stephen explains, “Workflow solutions delivered by BLUE allow clients to submit orders, which are in graphics format, online.” These orders are then picked up by the respective stakeholders for further processing. Users can digitally approve the art works and the workflow automatically moves the order to the next stakeholder with appropriate status updates and approval comments. Such automated workflow improves efficiency and minimizes the chances of manual errors to a great extent.

Apart from hosted SaaS platform, BlueSoftware also assists clients in adopting best pharmaceutical practices and help pass validation processes. There are 3 basic areas of validation that the company assists: Installation Qualification (IQ), Operation Qualification(OQ) and performance qualification (PQ). Stephen defines, “We understand a lot of the best practices in the pharma industry and help clients create and then validate a workflow that takes care of both regulatory and quality challenges.”

Unfolding the New Territories

In a highly regulated pharma industry where companies need to adhere to stringent quality and regulatory compliance norms, it becomes even more crucial that labels put on drug samples be accurate and has been approved by the local regulatory authorities and that this data stays true throughout the product lifetime. Unlike the over-the-counter (OTC) drugs, prescription drugs are patented with limited life-span. So, the duration for which the drug can be sold in the market depends on the patent conditions. Pharma is an evolving industry, and BlueSoftware understands well that staying abreast with the technology is the only way to stay in the game. The company complies with SAS 70, which is a basic hosting and security process. Clients often visit the site and perform audit on company’s security policies and practices. It also hires third party firms to try and attempt to steal information from a mock customer site hosted in the same way as a real customer site. These penetration companies probe weaknesses, looking for any security lapse that might be discovered during the process. “We take very proactive stance when it comes to data security. All of the data that goes in and out of Blue’s data center is encrypted with 128 bit data quality encryption key, and most importantly, it never sends the actual graphic outside the cloud,” confirms Stephen. The company abides by the international standards like cGMP, GAMP, and 21 CFR part 11 to help clients comply and sell their products. Further, it plans to educate clients on the nuances of regional markets. Stephen expounds, “We may do that from either a marketing perspective or a legal perspective. This brings the graphic to the expertise instead of bringing the expertise to the graphic.”

BlueSoftware’s annual revenue is over $565 Million. Stephen says, “Over the years, we’ve brought more expertise and tried to pick the best of each product group to offer flexibility.” Recently, it procured Kodak Designs to supply software to pharmaceutical companies such as Pfizer, ABDVIE and GlaxoSmithKline. The company is now integrating Kodak products into the BLUE platform to drive new levels of innovation. Moreover, it plans to integrate 3D objects, which allows artworks to be viewed from different angles. It is also working on Virtual Reality (VR) so that clients view the product in a VR environment prior to manufacturing to experience the product in different context. Stephen concludes on a futuristic note, “VR is going to rapidly expand in the areas of our software, and so we intend to be in the forefront of virtual reality application as it applies to graphic art management.”