Client Business Situation

Client was trying to manage a complex enterprise enforcement remediation activity without the benefit of useable information on quality systems' metrics or quality system effectiveness. Most site quality information was being collected on Microsoft Excel spreadsheets, with much difficulty, and being emailed to a central location for consolidation and subsequent publishing. The information was often weeks or up to a month old, and had little accuracy or consistency, since data standards had not been applied nor data aggregation rules defined.

Client Business Pain

Client executive management was having a difficult time determining what activities should be escalated for management focus, given the poor quality of the data and information and the dated and inconsistent nature. Without adequate information and real-time metrics for analysis and follow-up, remediation activities were proving difficult to complete, and executive focus was not resulting in sufficiently rapid change.

Solutions Provided / Services Delivered

As part of a larger, enterprise compliance remediation effort, Compliance Architects^® conceptualized, developed and implemented an innovative, Microsoft Sharepoint^®-based quality and compliance metrics reporting portal, to provide enterprise visibility across multiple sites, regulated product classes and quality subsystems. Integrating information previously contained within the disparate Microsoft Excel spreadsheets, and integrating real-time information from a specialized computer-based NC/CAPA system, the Quality Operations Portal has evolved to contain real-time data on NC, CAPA, recall, holds, supplier quality, external manufacturing, change control, training and other quality system reporting datasets.

Benefits Realized

The Quality Operations Portal has become the "go-to" executive quality management destination for real-time information on site and company quality and compliance performance. Continuously enhanced, the site permits information to be immediately available to executive management, resulting in improved focus, reduced compliance risk and reduced business risk. Further, by leveraging an already installed version of Microsoft Sharepoint^®, Compliance Architects^® was able to save substantial amounts of money on IT infrastructure and application costs and ensure consistency with internal IT / IS standards.