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 21 CFR Part 11 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 Agilent ICP Expert 21 CFR Part 11 software (Version 7.X and later) that couples ICP Expert software with Spectroscopy Configuration Manager (SCM) and the Spectroscopy Database Administrator (SDA). It is the responsibility of the

Join for free to read