Roger E Gould

Many Life Science organizations consist of multiple business units, and while they are generally supported consistently by quality governance, they most often find themselves faced with difficulty integrating IT quality workflows, data, and systems across business units in an efficient way which provides them the necessary business decision support and quality management. developing an IT Quality and Regulatory (Q&R) strategy that supports and is supported by business strategy is critical for generating business value and maintaining compliance. This will be accomplished by taking a hierarchical approach to strategy definition. Breaking the effort into strategic imperatives will allow senior leadership to identify and align key stakeholders with the effort. Next, IT Initiatives in support of each Imperative shall be defined. The current IT inventory, existing in-flight projects, and future solutions will all be taken into consideration. The resulting road map will allow the organization to align, people, policies, procedures, and governance to a unified IT Q&R strategy for accomplishing these goals.