establishing documented evidence of a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics
Center for Devices and Radiological Health (CDRH), General Principles of Software Validation; Final Guidance for Industry and FDA Staff, CBER CDRH/OC Doc. N. 938, January 11, 2002. Publicly available via http://www.fda.gov/RegulatoryInformation/Guidances/ucm085281.htm
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