Dr. Wayne Taylor - Taylor Enterprises, Inc.
for Engineers and Quality in the FDA Regulated Industries
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Six Sigma Validation Process
The 11-step validation process provides a step-by-step procedure for applying the Six Sigma tools to validating a pharmaceutical, medical device, or diagnostic device process per the FDA process validation guidelines. Dr. Taylor is author of part of the Process Validation Guidance (598 KB, pdf format) document recently released by the Global Harmonization Task Force (GHTF) Study Group #3. The validation process provides further details for accomplishing the fourth phase of the design process for manufacturing processes. This validation process follows the IQ-OP-PQ model laid out in this guidance document:
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Last modified: September 08, 2017