Since the early 1990’s, many regulated companies across the globe have deployed document management technology. These systems have effectively been used to manage all types of documents from those mandated by regulations such as cGxP and ISO to those required for normal business operations. Since the early 2000’s, regulated companies are in the midst of what can only be characterized as a compliance “perfect storm” represented by the convergence of 3 energized forces: (1) security, (2) privacy, and (3) retention.
The industry spawned many niche vendors in the late 1990’s that delivered document management-based solutions to solve many regulatory challenges. We had regulatory submissions systems, SOP management systems, change control systems, and a myriad of complimentary technologies for publishing, imaging, document comparison and so on that promised efficiency, compliance, and quality control.
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