Embracing Change in Regulatory Information Management (RIM): Technology Can Help to Make Compliance Transparent and Boost Organizational Efficiency and Effectiveness

By Dr. Alan S. Louie – September 17, 2014
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The persistence of elegantly crafted and refined paper templates and Excel spreadsheets to manage regulated documents and processes in the life sciences can in large part be attributed to a strong resistance to change, the lack of time, money, and a measurable ROI needed to assess and validate new solution approaches. At the same time, the increasing use of external partners is further complicating document and process management for regulatory and IT staff, with many key project and process managers increasingly residing outside of the organization and often thousands of miles away geographically. While it may have been possible in the past to walk across the hall in the past to collect a signature or determine the status of a submission, today's efforts routinely rely on less personal phone or email to track project status and hear about issues that may arise. As an additional concern, documents supporting regulatory compliance often reside across multiple systems, including email, separate document repositories, individual laptop/desktops, and manual filing systems. Beyond conversion to electronic versions of their historically paper documents and processes, electronic content management systems (CMS) are designed to capture supporting metadata that can add significant immediate value to regulated documents and processes.


About the author

Dr. Alan S. Louie

Research DirectorIDC Health Insights

Dr. Alan Louie is Research Director at IDC Health Insights. In this role, he is spearheading the company’s research covering innovation and best practices in pharmaceutical R&D and personalized…


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