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Based on the increased use of computer systems in the pharmaceutical industry,the United States Food and Drug Administration (US FDA) issued the 21 CFR Part 11regulations in March of 1997. This regulation provides the criteria for acceptance bythe FDA, under certain circumstances, of electronic records, electronic signatures,and handwritten signatures executed to electronic records as equivalent […]
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Donna Griffith
Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.
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