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FDAnews Drug Daily Bulletin

PART 11 COMPLIANCE FUELS REGULATORY IT SPENDING, SAYS SURVEY

Jan. 16, 2006

Life sciences industry spending on IT is rising rapidly and poised to accelerate more than 15 percent each year through 2011, in part due to Part 11 compliance and legacy system remediation projects, says a survey from Frost & Sullivan.

"The life sciences industry is now in a period of transition, as it seeks to use IT in resolving the process inefficiencies that cause a lot of dollars to be wasted across the spectrum, from R&D to post-marketing," said Raghavendra Chitta, an industry analyst with Frost & Sullivan. "These companies are now witnessing a sharp uptake of IT tools, which is not limited to the drug discovery process in the life sciences industry."

Regulatory requirements are now one of the main drivers of IT spending in the life sciences industry, the survey said. The recent drug withdrawals have brought about an increased focus on pharmacovigilance and related regulatory compliance. There have also been huge investments to achieve Part 11 and other related compliance.

While big pharma companies hold potential for IT vendors because of their more mature, predictable and large IT budgets, they are also more complex customers, the survey says. The recent drug recalls and pricing pressures have triggered rationalization of operational costs. The larger pharmaceutical companies have already replaced legacy systems or are replacing them, thus leaving little chance for increased IT spending.