Achieving IT Compliance While Controlling Costs Shouldn’t Be a Juggling Act, Says Life Science Insights

FRAMINGHAM, MA – January 25, 2005 – CIOs at pharmaceutical and biotechnology organizations are experiencing a dramatic increase in both the volume and complexity of compliance requirements. While these regulations mandate good clinical, laboratory and manufacturing practices (GxP) and privacy and fiscal rules, they greatly implicate IT systems, both transactional and informational, as well as IT work practices for the system life cycles. According to Life Science Insights (LSI), CIOs in the industry are scrambling to meet these requirements without draining resources.

"CIOs are becoming increasingly frustrated with the burden of IT compliance," said Senior Research Analyst, Judy Hanover. "Growing concerns include competing compliance initiatives, audit fatigue, low staff morale, competition for resources, and the challenges for effective and efficient IT compliance systems in fragmented, global environments."

To gain a better understanding of compliance demands, CIOs must avoid focusing narrowly on single requirements when broader issues may exist that can be addressed more efficiently at the global and enterprise level. According to LSI, many life science organizations are driving compliance activities without any apparent collaboration or sharing of processes and institutional learning. This fragmented approach often results in overlapping compliance regulations and confusion.

In its study, Worldwide Regulatory Compliance Issues in Life Science (LSI # 32690), LSI provides a working taxonomy of regulations that affect life science organizations and extracts the salient points at an executive level of detail. The document also offers direction on areas where CIOs of pharma and biotech organizations should focus their attention: governance, work practices, and technology.

This working taxonomy functions to help CIOs strategically plan for addressing compliance initiatives, including prioritization based on the current status quo and highest risk areas. LSI further discusses key issues CIOs should consider in regards to their compliance strategy, methodologies and associated costs in a recent telebriefing, "The Compliance Challenge in Life Science."

In the telebriefing, LSI highlights that conclusive benchmarking is necessary for companies to evaluate their compliance strategy, make necessary changes and control costs while mitigating risk. By taking a best practice approach to compliance, LSI believes life science organizations can meet objectives while maintaining the ability to respond flexibly to changing compliance requirements, regardless of the source of the regulations.

For more information on the "The Compliance Challenge in Life Science," telebriefing, to listen to a Real Audio replay or receive a copy of the presentation, please contact Tammy Gilson-Hodge at 508-988-6746.

For additional details on the Worldwide Regulatory Compliance Issues in Life Science (LSI # 32690) report and other Life Science Insights' information services for business executives, please contact Paul Hands at 508-988-6751.

About Life Science Insights, An IDC Company

Life Science Insights, an IDC Company, provides market research, analysis and consulting services to decision makers in life science markets. Clients include pharmaceutical and biotechnology companies, contract research organizations (CROs), government research organizations and technology vendors. Life Science Insights' team of specialist analysts and consultants provide intelligence and advice on technology trends, key market drivers, and end-user intentions. Founded in January 2004, Life Science Insights is headquartered in Framingham, MA.

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