QMS Implementations Lack Visibility in Global and Outsourced Environments

By Daniel R. Matlis

The lack of visibility most Quality Management System (QMS) implementations provide in Global and Outsourced environments is one of the key findings from Axendia’s “Quality Management System trends in Life Sciences” research study. 

The study gathered input from over 125 companies, covering small, mid-size, and Fortune 100 Life-Science organizations representing the full spectrum of medical device, pharmaceutical, biotech and diagnostic organizations.

According to our analysis, most QMS implementations in Life-Science companies are fragmented and lack real-time visibility outside the organization’s 4-walls. While typical QMS implementations provide a reasonable view at the local or site level, they fall short on delivering visibility across the enterprise. This is especially significant, given that 75% of respondents belong to multi-site organizations. For those companies that have multiple sites the survey shows that:

  • 34% can roll up QMS data from multiple locations in real time
  • 37% need to aggregate the data from multiple locations
  • 29% say it is not possible to rollup data from multiple locations.

This lack of real-time visibility can be a barrier to in-depth root analysis. This may be a key factor in promoting corrective, rather than preventive approaches to managing non-conformances. In today’s increasingly Global and Outsourced Life-Science value chains, real-time visibility across organizational boundaries, as well as supplier and external partner networks, are no longer a nicety but a competitive necessity.

To learn more, join me in a webinar sponsored by Camstar on May 5th, 2009 at 1:00 PM EDT. In this webinar, we will be sharing in-depth analysis and recommendations on the need to shift from a fragmented approach to QMS implementations in light of our industry’s increasingly Global and Outsourced Environments.

To register for this webinar visit: http://www.camstar.info/041409_axendia_webinar_series/

For additional information on the “Quality Management System Trends in Life Sciences” research visit: http://lsp.axendia.com/qms-trends/

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