BUSINESS CASE ALK PREPARES FOR A RIM BUSINESS-FIRST APPROACH SYSTEM TO SUPPORT The Global Regulatory Affairs department at ALK provides the company with leadership and guidance on regulatory matters throughout the life cycle of a drug. They work closely...
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BUSINESS CASE ALK PREPARES FOR A RIM BUSINESS-FIRST APPROACH SYSTEM TO SUPPORT The Global Regulatory Affairs department at ALK provides the company with leadership and guidance on regulatory matters throughout the life cycle of a drug. They work closely with many stakeholders to influence governance and decision making. Over time, ALK found that their Regulatory system setup didn’t assist their efforts to achieve this mission. An EDMS system for proper management of submission documents was required, and even though their current RIMS (Regulatory Information Management System) for tracking was largely well-functioning, it was quite inflexible. “One of the main drivers for replacing the RIMS was the lack of flexible reporting functionality. We have a relatively complex product portfolio, and this downside was impacting us” explains Ida Bastian Brügger, Team Lead for Compliance and Operations in Global Regulatory Affairs at ALK. Necessity became the mother of invention and they came up w
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