FWS 6i, específicamente diseñada para las industrias farmacéutica y de cosmética, permite a los investigadores de Pfizer trabajar con los diferentes escenarios de costes y regulatorios para de esta manera optimizar las fórmulas de posibles nuevos medicamentos antes incluso de que éstas lleguen a los laboratorios.
Con FW6i los científicos que trabajan en cualquiera de los centros de investigación de la empresa farmacéutica pueden, además de crear y editar sus nuevas fórmulas, realizar búsquedas de otros ingredientes, realizar cálculos automáticos, ver otras fórmulas experimentales y crear documentos siempre dentro de los requerimientos legales de la FDA (Federal Drugs Agency) respecto a las firmas y el archivo digital. Documentum, por su parte, provee de un repositorio seguro con control sobre las versiones, workflow automatizado y rutinas de revisión y aprobación electrónica.
Para terminar, un ejemplo: elaborar 15 diferentes fórmulas con sus respectivas documentaciones en el proceso del desarrollo de un producto podía llevar antes dos días enteros. Ahora, con el nuevo sistema, lleva 20 minutos.
Para más información leer la siguiente nota de prensa en inglés.
Pfizer Discloses Its «Best Kept Secret» at Momentum 2003; FWS 6i and Documentum Speed Time-to-Market and Reduce Product Cost
NEW ORLEANS Dec. 8, 2003 Pfizer Inc., the world’s leading research-based pharmaceutical company, recently presented what they termed their «Best Kept Secret» — the integration of IMS FWS 6i with Documentum’s enterprise content management platform. IMS Inc., a leader in enterprise formulation software, provides the collaborative product design component of Product Lifecycle Management (PLM) for Global 2000 companies in the Pharmaceutical, OTC Drug, CPG and Cosmetic industries.
Speaking at Documentum’s Momentum 2003 conference in New Orleans Nov. 9 – 12, Rose-Emily Calo, Associate Director of Document Management Services for Pfizer Consumer Healthcare, explained how FWS 6i combined with Documentum synchronized Pfizer’s innovation, scientists, formulations and processes. Calo detailed the impact this system has had on global development, citing as an example a Pfizer product development scientist who found she could create 15 variations of a formula along with required reports and paperwork in 20 minutes. On the old system it would have taken her two full days.
Pfizer Consumer Healthcare, which develops and manufactures many of the world’s best-known consumer brands, uses FWS 6i and Documentum to bring structure to the formula development process, without constraining the creativity of their innovators. According to Calo, these advanced, highly integrated tools empower scientists to share knowledge and create more breakthroughs via use of a global electronic repository of all marketed and experimental formulas.
«We’re gratified to see how FWS 6i’s global collaborative framework empowers innovation and shortens time-to-market for companies like Pfizer,» said Dr. John Sottery, founder and CEO of IMS Inc. «Our software allows scientists to quickly run multiple cost and regulatory scenarios — to optimize formulas before they are ever made in the lab. It also provides enhanced accuracy for regulatory approval, minimizing costly project delays.»
Calo explained that Pfizer previously had highly innovative scientists creating breakthrough formulations on floppy disks, and most of their product development documentation resided on paper. This fragmented their knowledge base at the local and global research levels and made the access, review and approval processes problematic. In 2002 Pfizer integrated FWS 6i with Documentum as part of their TechDocs 2.0 project. Hundreds of scientists globally use that system to access thousands of shared formulations.
With FWS 6i, users at Pfizer can create and edit formulas, search for formulas and ingredients, view others experimental formulas, perform automatic calculations, and create documents, all while complying with the FDA’s regulatory requirements for electronic records and signatures (21 CFR Part 11). Documentum provides a secure global repository with version control, automated workflow, and electronic routing for review and approval.
About IMS
IMS Inc. drives the success of Global 2000 companies in the Pharmaceutical, OTC Drug, CPG and Cosmetic industries around the world by empowering their product development organizations to bring superior formulations to market, more rapidly and at lower cost. Over the last ten years, IMS has worked closely with both IT and Product Development groups at leading global CPG and Pharmaceutical companies to develop FWS 6i — a world-class, best-practices approach to collaborative formulation design and Product Lifecycle Management. For more information about IMS visit www.ims-usa.com or call (203) 874-2655.