Published: 01 March 2000
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.
Included in Full Research