Beating The Compliance Challenges- Perspectives for Pharma CIOs

Beating The Compliance Challenges- Perspectives for Pharma CIOs

With the business model straining to operate at scale, Life Sciences companies are entrusting CIOs with insurmountable responsibilities of doing three things simultaneously -

? Drastically improving the efficiency of IT
? Use IT to drive business innovation
? Ensure regulatory compliance in the entire life-cycle

The earlier and current decade has seen inorganic growth with mergers and acquisitions. The more companies work together, the more it becomes difficult to standardize and integrate the different business processes, initiate strategic drives and outcomes, the capital and operational budgeting and most importantly, smoothen the cultural sensitivities and professional environment. Never before CIOs had to face these challenges and also resolve them quickly.CIOs occupying the centre-stage face the triple challenges of improving IT efficiency, using IT for driving business innovation and managing the ever-changing regulatory focus and requirements. We propose a TCS compliance solution that works on a three-step approach. They are:

1. High-level consulting using the TCS proprietary TM Compliance Maturity Model (COMM) - TM
2. Implementation of Compliance Office Solution (COS)
3. Management of CAPA (Corrective and Preventive actions) and metrics evaluation to measure the predefined success rating and Return-On-Investment (ROI).

The TCS compliance solution helps the client establish a robust regulatory IT compliance system that ensures ‘audit readiness’ and ‘high degree of compliance’ to various regulations at a competitive cost.

Industry Challenges: Demanding Time for CIOs

The Life Sciences industry—buffeted by the possibility of increasing price controls, declining drug-development productivity (higher costs, fewer drugs), stricter regulatory scrutiny, and tighter competition from a growing number of me-too drugs—is in a state of turbulence. This instability is squeezing the bottom-line of the industry players, which is reflected in the decrease of their earnings by 25 percent since 2002. As a precursor, companies should think of transformation of core business processes with more adoption of IT (such as in drug development and commercialization), seek new ways to increase their yield and productivity, and at the same time be compliant to the dynamic and stringent regulatory clauses and guidelines.

With the business model straining to operate at that scale, Life Sciences companies are entrusting Chief Information Officers (CIOs) with insurmountable responsibilities of doing the following three things simultaneously:

o Drastically improving the efficiency of IT
o Using IT to drive business innovation
o Ensuring regulatory compliance in the entire life cycle

The earlier and the current decade have seen inorganic growth with mergers and acquisitions. The more companies work together, the more difficult it becomes in terms of the following:

o Smoothening the cultural sensitivities and professional environment.
o Standardizing and integrating the different business processes
o Initiating strategic drives and outcomes
o Budgeting capital and operations

The CIOs have never had to face such challenges before and resolve them quickly. They can take this as an opportunity to become the true pioneers of leadership by example. A way to address these challenges by CIOs will be to tackle IT efficiency, focus on IT-driven business innovation, and establish a robust regulatory IT compliance system. For the scope of this white paper we will limit our discussion to the challenges faced by the entire Life Sciences industry in establishing a robust regulatory IT compliance system.

Download

Download full seminar papers At
http://www.enjineer.com/forum