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The ISPE Quality Metrics Pilot Program Wave 2 Report provides a further understanding of the relationships first reported in the ISPE Quality Metrics Pilot Wave 1 Report. In the Wave 2 pilot:
During the planning of the Wave 2 pilot, the USFDA issued its Request for Quality Metrics FRN and Draft Guidance. The Wave 2 pilot was adjusted to include:
The ISPE Quality Metrics Pilot Program Wave 2 Report provides an in-depth understanding of:
ISPE, in cooperation with McKinsey and Company and 21 participating companies, designed and undertook an extensive Pilot Program from 2014 to 2016 to test the feasibility of collecting and reporting a standardized set of quality metrics.
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