Gartner Research

40% of Your Pharmaceutical IT Budget Is Spent on Regulatory Compliance

Published: 01 March 2000

ID: G00191672

Analyst(s): Roddy Martin

Summary

Information Technology (IT) that supports manufacturing-sensitive operations must comply with Food and Drug Administration (FDA) requirements for Current Good Manufacturing Practice (cGMP). Building and maintaining compliant IT systems to support manufacturing requires a lifecycle approach to IT and alignment between IT, Quality Assurance (QA), business processes, manufacturing operations, and record management to reduce ownership costs and ensure compliance. While manufacturing operations units enforce IT compliance through validation, corporate IT services do not have a strategy to manage increasing compliance costs across the enterprise and are distant from detail manufacturing, research, and development operations.

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