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...The traditional approach "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.
INTRODUCTION
The traditional method of working in silos is not helping pharmaceutical companies combat the steep increases in the costs of drug development and sales and marketing nor does it enhance the productivity of workhorse manufacturing. In fact, it is posing a threat to double-digit growth. Pharmaceutical organizations are, therefore, considering IT as a facilitator to create a global collaborative work environment and to rein in the rising costs of drug development.
As IT is infused into all operations across the pharma value chain, regulatory compliance needs in IT-related activities are becoming significant. The traditional industry approach of not imposing Good Manufacturing, Clinical, and Laboratory Practice (GXP) requirements in IT areas has changed significantly in recent years. IT divisions are playing a more notable role in improving business productivity and are becoming the core component of every business function under regulatory authority's scrutiny. Thus, computer systems come under the purview of regulatory authority to bring more focus to IT processes, Standard Operating Procedures (SOPs), Change Management, Risk Management, Corrective And Preventive Action (CAPA), and revalidation. Compliant IT processes now require considerably more rigor in documentation, review, and verification than previously accepted. This increases the overall cost of a project in comparison with traditional IT development project costs. The need for computer system validation further adds to costs.
Thus, on the one hand, the pharmaceutical industry is trying to leverage technology-driven productivity to drive down costs across the value chain, and on the other hand, it faces the inherent investment demands of IT projects. The magnitude of the challenge is compounded as pharma companies outsource IT services to drive down IT costs. To achieve an efficient balance between these...
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