Software giant Microsoft Corp., Redmond, Wash., has unveiled its Digital Pharma initiative, which encompasses a solutions framework for pharmaceutical and life sciences companes that must meet various Food and Drug Administration regulations for digital signatures and process validation. The initiative, announced on March 15, is supported by 18 additional vendors, Microsoft said. The initiative addresses two industry imperatives—speed-to-insight and value-for-cost.
Speed-to-insight defines the ability to connect disparate resources and data, so that quicker and more useful insights can be achieved across the value chain, from drug development and data collection to business intelligence and marketing effectiveness, thereby enabling effective and timely critical decision-making.
Value-for-cost recognizes the imperative for pharmaceutical companies to realize a disproportionately greater return on new and existing investments in a demanding marketplace. By developing systems to get the most out of proven technology and extending existing information technology (IT) investments, Microsoft and its partners aim to help companies create business efficiencies that can increase return on investment while speeding innovation.
OSIsoft, a San Leandro, Calif., software supplier, concurrently announced its support for the Microsoft initiative. The company’s Real-time Performance Management (RtPM) software platform with its Pi historian system offers real-time actionable performance metrics for pharmaceutical and biotechnology organizations. The platform provides the full audit trail required by regulators and can be applied atop many existing systems.
Marc Gallant, Pharmaceutical Industry manager for OSIsoft, says the Initiative is about the use of Microsoft technologies such as the .Net platform to reduce manufacturers’ cost of ownership and bring together disparate legacy systems that are otherwise hard to integrate. “We offer operations visibility across the business and plant floor by recording and reporting information. The application originally was focused on quality of documentation. Now it is providing a true process understanding with understanding of key materials and ability to provide some supply chain feed-forward control,” states Gallant.