Articles
Enterprise Resource Planning Systems
April 3, 2009
•Feature Article: Enterprise Resource Planning Systems
By Michael Webster
Few industries have as many regulatory agencies dictating how to process and control their products as the pharmaceutical industry does. Its compliance responsibilities have been growing in the past few years, extending beyond the realm of manufacturing and quality into financial and distribution systems. Sarbanes-Oxley (1) and drug pedigrees are foremost among recent regulations heaped onto the backs of pharmaceutical companies by state and federal agencies. Compliance with the new mandates can be costly and time-exhaustive, but penalties for noncompliance are often severe. Huge fines from the Securities and Exchange Commission and the Department of Justice—even imprisonment—are becoming more prevalent.
Reprinted with permission from BioProcess International 4(3) (March 2006)
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