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For pharmaceutical companies, the process of introducing new medicines involves several internal departments working with external stakeholders in a highly regulated environment. Lead development produces volumes of scientific research that will produce only a handful of compelling new innovations for potential development. Once scientific and business evaluations are completed, these innovations will advance through regulatory processes such as the IND, dose ranging studies, human clinical trials, and the eCTD, going on to be manufactured in facilities using processes that meet FDA guidelines and standards. Early document management vigilance can improve workflow, maintain project timelines, and provide greater collaboration throughout the various phases of development and commercialization that support corporate strategic lifecycle and market decisions.
MasterControl automated process management and document management systems provide access of information to cross-functional teams. The system provides instant email messaging, revision draft vaults, and encrypted password protection. Tem members, managers, and senior managers can access important product documents in real-time and work accurately, efficiently and collaboratively to support company speed-to-market milestones.
MasterControl automates pharmaceutical GxP processes to improve efficiency and speed time to market. Processes include: