White Paper Overview US FDA Part 11 in Title 21 of the Code of Federal Regulations (CFR), and its EU analog, Eudralex Chapter 4, Annex 11, describe the requirements for electronic records and electronic signatures for regulated pharmaceutical organizations. Released in 1997, 21 CFR Part 11 has been enforced since 1999. The intent of these guidelines is to ensure that all appropriate electronic records are attributable, legible, contemporaneous, original, accurate, and maintained with integrity. This white paper is a resource for users of OpenLab ECM in organizations that must comply with these regulations. OpenLab ECM provides a central secured repository for data acquired and processed by Agilent’s data systems (e.g., OpenLab CDS) and non-Agilent’s data systems (e.g., Water’s Emp

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