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Industry Leader Implementing On-Demand Visibility To Improve Outcomes and finished goods went out the other. Around that time, industry and regula- tors began to collaborate to change the pharma manufacturing paradigm from "testing quality out" to "building quality in." This resulted in approaches such as process analytical technology (PAT) and quality by design (QbD), which drove industry to gain a deeper understanding of product characteristics and manufac- turing processes to allow for tight con- trols over critical-to-quality parameters. Around the same time, life sciences companies began experimenting with outsourcing. Today, outsourcing is com- mon, but has an unintended conse- quence — many brand owners have lost the ability to collect and capitalize on critical-to-quality parameters stored at an external facility. This data is not only needed to improve productivity, qual- ity, and reliability, but also can have a significant effect on product safety and efficacy as well as innovation and regula- tory compliance. T 50 OUTSOURCING VISIBILITY Globalization and outsourcing are here to stay. However, increases in outsourc- ing and globalization do not translate to a loss of visibility or responsibility. A key challenge is that, today, visibility into the outsourced supply chain is pri- marily based on snapshots in time with little sharing of common practices and information. Our research shows that 77% of organizations rely on periodic audits as the primary method to gain visibility into suppliers. Yet surpris- The CMO Leadership Awards 2012 wo decades ago, most life sciences companies were vertically integrat- ed. Raw material came in one end of the operation, ingly, only 25% of organizations share common practices and information with suppliers, and only 3% have access to suppliers' data in real time. IMPROVING OUTCOMES WITH ON-DEMAND VISIBILITY To address these challenges, brand own- ers must implement strategies to pro- vide on-demand visibility across every stakeholder in their supply network. On-demand-visibility would ensure that organizations could actually get the information they need in order to support full genealogy and trace- ability across the supply chain. A key component to this is the willingness of partners to share information. In an age when outsourcers are outsourcing, the chain gets longer and even more diffi- cult to assess. As a result, brand owners need to treat outsourced organizations as an extension of their quality systems, so they maintain consistent standards across all sites. To achieve control out- side the corporate walls, brand owners should deploy processes and systems that enable them to connect the dots and bridge the gaps, regardless of who made a component or ingredient, or where it was made. A key business practice is for brand owners to require suppliers and part- ners to provide a complete batch-his- tory record for the raw materials/com- ponents being delivered, instead of a certificate representing a snapshot in time. Batch records provide visibility into critical-to-quality parameters, facili- tating the ability to adjust downstream processes. To support this level of transpar- ency, brand owners and their supply networks should collaborate to inte- grate rigid command and control sys- tems (e.g. ERP [enterprise resource Daniel Matlis Daniel Matlis is president of Axendia, a life sciences and healthcare analyst and strategic advisory firm. Matlis has more than 22 years of industry experience, having previously held positions with J&J;'s Ethicon division and Stelex. planning], QMS [quality management system]) with Web portals and cloud- based supply chain intelligence infra- structures. This approach would allow life sciences stakeholders to be able to take full advantage of tools such as scorecards, dashboards, and event man- agement approaches to support global supply chain optimization, transpar- ency, and control. On-demand visibility strategies pro- vide the ability to obtain relevant infor- mation about the life sciences prod- uct at the appropriate time to enable decisions with a high degree of con- fidence based on the analysis of con- temporary data. This approach would provide brand owners the opportu- nity to improve quality and manage costs by enabling process optimization and adjustment of critical-to-quality in-pro- cess parameters within a design space. Maintaining on-demand visibility of upstream processes (whether internal or outsourced, local or global) allows down- stream control strategies to take into account the actual characteristics of raw materials, ingredients, and components. This approach would support improved productivity, quality, and reliability, as well as foster innovation and facilitate regulatory compliance. INDUSTRY LEADER