BlueSoftware: Advanced Labelling and Workflow Solutions for Pharma Industry

Stephen Kaufman, Chief Product Officer

When one opens the packaging of a pharma product, out comes a tiny piece of paper. However, not many people take notice of this little piece of paper wedged on the prescription medicine bottles. Medical practitioners, however, routinely do. They meticulously look into the drug labels for more information before prescribing them to their patients. The labels on the bottle and on the packaging box contain copious amounts of data which is crucial throughout the product lifecycle: from production to prescription and disposal. Any change in schedule should be captured in the labels and corrective actions must follow to ascertain the propriety. Evidently, evaluation of drug labels is a critical pass criterion in the pharma products before they hit the markets. Given the sheer complexity involved in the drug delivery process, drug labels play a major role, and information technology is used at every stage to guarantee an efficient workflow. Visualizing the necessity as well as an opportunity, Stephen Kauffman, an industry veteran incepted BlueSoftware with an objective to revolutionize the packaging and labelling processes involved in the Pharma industry. The company’s flagship platform, Blue which is a SaaS solution for graphics workflow management and optimization has enabled the company to carve a strong niche for itself in the market. The platform helps clients in marketing process management, packaging design process, online review management, digital asset management and product performance. Stephen Kaufman, Chief Product Officer of BlueSoftware, adds, “in addition to our flagship product, it is the speed and quality of our services which have been the top driving forces for our company’s success.”

Commencing with a sole pharmaceutical client, BlueSoftware over its 12 year long presence in the industry has had an enthralling journey serving nearly 100000 users, across 12000 brands and 5000 companies, spread across more than 150 countries with its single integrated delivery platform. In this process, the company has received countless testimonies from several clients including Merck pharmaceutical, Global Pharmaceutical Manufacturer, United States Gypsum, Shrine Blind, Elanco blind and many more. Head of Artwork & Technical Operations at Global Pharmaceutical Manufacturer, showers praises saying, “Keeping our Packaging BOM data up-to-date was critical to our business and we have been able to demonstrate the business value of using BLUE Connect to transfer data between BLUE and SAP.” Yet another testimony comes from Chris Miller, Business Systems Analyst, Shire, “After completing our BLUE integration with SAP, both the Artwork and Planning groups have much greater visibility into the product artwork lifecycle. Everyone at BLUE, particularly the Customization and Project Management teams, stepped up to ensure the project went live on time.” Such testimonies from some of the pharma industry bigwigs reflect the value proposition BLUE brings to the table and its commitment to its client success.

The Blue and BlueSoftware Flow

Since the late 1990s, several multinational companies forayed into the pharmaceutical and consumer products industry. Soon, they began facing challenges pertaining to managing their digital assets stored in the form of graphic art works. At that time, though computer hard drives and Compact Discs were able to store digital artworks, there was no way to correlate, search, or filter them. There were no means to distribute the information securely across the globe. This led, BlueSoftware to venture out out as a digital assets management company. It organization’s priority was to move digital artworks from specialized software suites to easily view able web browsers. Stephen recalls, “At that point we had two distinct offerings: An easily brows able digital assets library which could be accessed using a web browser, and a workflow solution, which could move graphics or information through organization’s internal processes and into-and-out of their supply chain.” It helped ad-agencies, and design and pre-media firms in their printing process, and consequently, helped BLUE become the most preferred means for the pharmaceutical companies to communicate internally and with their suppliers in a structured workflow.

During its initial years, BlueSoftware delivered only on-premise software, however, in early 2000’s, the software deployment dynamics took a sharp turn and non-pharma clients started demanding that their software be hosted on the cloud and scale depending on the business needs. By 2010 pharmaceutical companies took notice of the growth in the cloud based deployments and began to accept the idea that cloud deployments can be as safe and secure as their on-premise hosted applications. It was at that infliction point that BlueSoftware observed rapid movement of pharmaceutical clients into its SaaS hosted software, and today almost all its clients are on SaaS platform, leaving a handful few who are still on-premise and are in the transition.

Intelligent algorithms drive BLUE’s workflows automatically. For instance, SAP system initiates new processes without any manual intervention from marketing or execution teams. Similarly, an integrated ERP system from SAP and Oracle continuously monitors client’s financial and manufacturing perspective and generates real-time reports. “Beginning in 2010, self-initiated workflows in BLUE has been a major step in our evolution, and now more than half of our pharma clients initiate their BLUE processes from their ERP,” Stephen elucidates.

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.”