SharePoint® Quality & Compliance Metrics Reporting

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SharePoint® Quality & Compliance Metrics Reporting

Client Business Situation

Pharmaceutical Quality MetricsClient 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.  Further, little meaningful analysis of the data aggregated was being performed, since all efforts were focused on the highly-inefficient data collection and aggregation process.

Client Business Pain

Substantial personnel resource time was being devoted to sending around massive spreadsheets, and trying to format and create derivative reports from the data.  Collected data was also being used for Management Review purposes, and Management Review preparation time averaged two months to gather and prepare information for the Management Review meeting.   Client Quality Management was having a difficult time determining what activities should be escalated for executive 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

Pharmaceutical Quality MetricsAs part of a larger, enterprise compliance remediation effort, Compliance Architects® conceptualized, developed and implemented an innovative, Microsoft SharePoint®-based quality and compliance metrics reporting model, to provide enterprise visibility across multiple sites, regulated product classes and quality subsystems.

Initial project activities focused on alignment of data definitions and sources across multiple regions, divisions and sites.   Significant work on alignment of definitions was necessary since many critical quality measures were not consistent from site to site, nor region to region.   Significant organizational resistance was experienced when changes to definitions were mandated to ensure cross-enterprise alignment.

By integrating information previously contained within the massive 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.   The solution delivery introduced the concept of “real-time” or “pushbutton” reporting where all data sets are updated, and customized, up-to-date reports are created, at the literal push of a button.

Benefits Realized

The Quality Operations Portal has become the “go-to” executive quality management destination for real-time quality and compliance metrics.  Regularly enhanced, the site permits quality metrics information to be immediately available to executive management, resulting in improved focus, reduced compliance risk and reduced business risk.  By leveraging the company’s enterprise installation of Microsoft SharePoint®, Compliance Architects® was able to save the company substantial amounts of money on IT infrastructure and license costs while ensuring consistency with internal IT/IS standards and establishing the long-term viability of the solution.

In addition, the critical Management Review process was greatly enhanced.   Preparation time for Management Review was reduced from over two months to less than one day due to the “pushbutton reporting” capability of the solution.   Although this resource reduction was welcomed, the biggest impact was the company’s ability to spend more time on analysis and assessment of acquired data — something that couldn’t be done with the previous activities.

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