Documentum is introducing ECM Solution for Life Sciences, designed to meet the specialized content management requirements of biotechnology, pharmaceutical and medical device companies; clinical research and contract manufacturing organizations (CRO/CMO); and governing bodies that regulate these industries.
Documentum's Life Sciences Solution is designed to help companies comply with complex, evolving regulatory policies, ensure that products are brought to market as q quickly as possible and that regulatory penalties, such as fines, manufacturing stoppages or product recalls are avoided.
Based on Documentum's core ECM technology, the solution enables lifecycle control of all documents, such as new drug applications (NDAs); auditing of content creation, revision and approvals to ensure regulatory compliance; sharing and reuse of
project-related content for team collaboration in product development and clinical trials.
The solution also supports cross-organizational collaboration, making it possible for companies to securely team with partners in joint research and development or clinical trials and interact with regulatory agencies for regulatory submissions.
"Life Sciences organizations are facing major challenges -- rising drug development costs, declining exclusivity periods, expiring patents, increased
regulatory requirements and stricter enforcement policies. As a result, they are scrutinizing every aspect of their operations for cost savings and productivity improvements," according to Kara Yokley, research manager, IDC.
"Being first to market is the single most valuable competitive advantage these
companies have. Because content management solutions can increase efficiencies
across the organization, in drug discoveries, clinical trials, submissions and regulatory approvals, while ensuring regulatory compliance, they should be an integral part of the IT strategy of all Life Sciences organizations."

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