The Life Sciences industry is spending large amounts of money on research in pursuit of new cures for current and future diseases. There is also a substantial amount spend on quality and living up against the ever-changing regulations. Spending money wisely is thus key and is a common theme in this industry.
Reducing cost can come in many ways but the Life Sciences industry – represented by the Drug Information Association – realized that it can also come by joining forces on non-competitive business processes. One of these is how documentation is managed. After all, they – from 2-men start-ups to billion dollar enterprises – face the same rules and regulations when it comes to documenting research, trials, submissions etc. Back in 2009 the DIA agreed to develop a flexible, open, free and sustainable model for the industry, from the industry and by the industry. Today we can benefit from their EDM and eTMF Reference Models that have resulted from this initiative.
Back in 1990, a request from the FDA to manage New Drug Application documents has – together with requirements from Boeing – led to the birth of Documentum. Ever since, they have a leading footprint in the Life Sciences industry. Today their Life Sciences Industry Solution platform brings the best of document management based on the DIA reference models. A preconfigured solution that not only includes the model but also the approval processes and training features.
At Informed Consulting, we not only know this set of solutions inside-out. We have complemented it with the products that are marketed through Informed Products: SPA4LS and EQMS Light. SPA4LS is a SharePoint add-on to support e.g. Partner Exchange and eTMF content transfers. EQMS Light is a Quality Management Solution targeted at those organizations that do not need all bells and whistles from enterprise class alternatives.