How Logilab SDMS helps Laboratories to enable 21 CFR Part 11 Compliance Part 1

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food & Drug Administration (FDA) regulations on electronic records & electronic signatures (ERES). Part 11 sets out how a company operating in the US can use electronic quality records & digital signatures in place of paper-based documentation & ‘wet signatures’ in such a way that complies with FDA regulations. [Read More]

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