IT compliance complexities worry CIOs

BANGALORE: CIOs from pharmaceutical and biotechnology organizations are experiencing a dramatic increase in both the volume and complexity of compliance requirements, according to a recently released IDC report.

While these regulations mandate good clinical, laboratory and manufacturing practices 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. 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," said Judy Hanover, senior research analyst.

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, observes the report.

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, LSI provides a working taxonomy of regulations that affect life science organizations and extracts the salient points at an executive level of detail. 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 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.