Creating a new GIC A3P eCompliance
The evolution of technologies and modes of "delivery" computing (Cloud, mobile computing ..), the context of merger / acquisition of pharmaceutical companies, the changing global landscape of information processing, the multiplication of stakeholders in the IT sector (industry), the increasing maturity of the users are all factors that challenge the organization and the processes associated with computer systems or automation in the pharmaceutical industry and biotechnology.
Regulatory constraints remain broadly unchanging and inspection reports show increased sensitivity to the problems of "data integrity".
Current approaches to validation remain focused on systems and not on the data / records that are supposed to produce and maintain; control systems and associated risk tends to move from software testing to more general checks of risk control points.
Vis-a-vis all these parameters, how to best adapt existing methodologies to keep flexibility and adapted to control risks? Such are the general issues that the ICG eCompliance seek to provide concrete answers and accomplished.