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WELCOME...
EduQuest, Inc.
is a leading provider of regulatory consulting, auditing, and training services
to the global pharmaceutical, biologics, and medical device industries.
EduQuest
also provides training to regulatory agency personnel, and was hired by the U.S.
Food and Drug Administration (FDA) to train its field investigators, analysts,
and headquarters compliance staff on 21 CFR Part 11 and the inspection of
computerized systems. Our team of consultants includes former senior FDA
officials and industry experts in quality, compliance, manufacturing, clinical
research, validation, and software development.
EduQuest's
areas of expertise include the validation of regulated computer systems,
requirements for electronic records and electronic signatures, process control
and validation, quality systems, internal auditing, regulatory compliance and
enforcement, and the full range of “GxP” (i.e., good manufacturing, good
laboratory, and good clinical practice) requirements.
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