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 Agilent Cary UV Workstation with OpenLab software, including the Control Panel and Content Management applications. The Cary UV Workstation software provides instrument control and data analysis for the Cary 3500 UV-Vis spectrophotometers. It is the responsibility of the user and their organization to ensure that the functionalities provided by this software package are used appropriately to achieve compliant operation for laboratory data acquisition and processing. In addition to the technical controls provided by the software, the user organization must establish procedural controls–standard operating procedures (SOPs)–to address relevant nontechnical requirements. For example, controls such as internal audit programs must also be established to ensure that system operators follow the SOPs.
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