This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
education, science & technology
training / biomedical / event / e-learning / conference / pharmaceutical / webinar / medical device / drug / medical devices / fda / clinical trial / compliance training / web seminar / compliance2go / excel spreadsheet / 21 cfr 11 / compliant environments / fda part 11 validation guidance. documentation
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