Tech Talk: A Q&A with Oracle's Arvindh Balakrishnan

Regulations such as 21 CFR Part 11 have been well understood (and implemented) by the industry for several years. However, for the first time, the life sciences industry is feeling the need to manage regulatory compliance across regulations on a risk-based approach. Often, there is one officer in the company who is charged with regulatory compliance, and this officer is keenly interested in mitigating risk proactively in a unified governance framework for the company.

The cost of noncompliance has become almost unfathomable in the pharmaceutical industry. Companies that are affected by noncompliance (be it a SOX [Sarbanes-Oxley] associated restatement or an FDA consent decree) suffer far beyond the superficial commercial aspects. Corporate culture, leadership, confidence in management, and even the capability to recruit and maintain talent are severely challenged. As a result, chief regulatory officers in the life sciences industry are at a very strategic helm, and their direct relevance to business continuity and growth is becoming well understood by boards of directors and investors.

View Full Article