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In today’s competitive environment it is the objective of all life science manufacturing companies to minimize
the risks of compliance non-conformance and the significant associated post-event costs. These costs are seen
in human resource non-production time allocations, production delays or halts, and ultimately shut downs and
product recalls with potential fines or consent decrees. The ultimate costs will be seen in the potential impacts to
patients. These costs can mount into the hundreds of millions of dollars and, as such, should be at the forefront
of boardroom discussions.