Module 12 2019

Example Industry Metrics

Quality

Completeness

Timeliness

% of artifacts that meet quality standards % of artifacts that have had queries or modifications

% of documents present that are expected at a given milestone or timepoint

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Time to set up TMF

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Time from finalisation to document uploaded into TMF Time from upload to QC completed

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% of documents without issues

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The Organisation for Professionals in Regulatory Affairs