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Labeling and Packaging Process Improvement Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2022)
Medical Device Companies must ensure that each unit of product has unique identification and that it is labeled correctly. Labeling requirements include having the appropriate data on the label, not ...
Quality Improvement Process for Software Controls in Regulated Industry using Six Sigma Methodology
(Polytechnic University of Puerto Rico, 2013)
A regulated industry at medical
devices company, Software Control practices on
Automated Processes are weak and not
systematized. Several findings were found in past
internal audits related to software revision
changes. ...