By Kamal Biswas

ABSTRACT
Soaring drug development costs, patent expiration, and reduction in the number of blockbuster drugs are driving pharma companies to look seriously at Information Technology (IT) enabled productivity. The pharma IT strategy must be strengthened to better support business needs. The traditional approach of “working for business” is evolving into a “working with business” model. Pharma IT processes must support this transformation and also manage mandatory regulatory requirements including the Food and Drug Administration’s (FDA) Code of Federal Regulations (CFR) 21 Part 11 and the Computer System Validation (CSV) providing a high degree of assurance of a system’s consistent performance. And IT process transformation must be able to deliver the right products, meeting all internal and external stakeholder needs including regulatory requirements.