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Two Day Computer systems Validation (CSV) for Excel Spreadsheets Workshop (San Diego, CA, United States - December 14-15, 2017)DUBLIN, October 30, 2017 /PRNewswire/ -- The "2 Days Workshop: Computer systems Validation (CSV) for Excel Spreadsheets" conference has been added to Research and Markets' offering. Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment. GxP records generated by spreadsheet calculations are electronic records and should comply with FDA's 21 CFR Part 11 and the European Annex 11. For critical records Part 11 controls, such as data accuracy and data integrity, should be implemented. Currently thee are no specific industry FDA guidelines on using spreadsheets in regulated environments. However, the flexibility and power of the spreadsheet allows users to create tools that range from performing simple calculations to sophisticated analysis of a major clinical study, or laboratory or manufacturing data. This makes spreadsheets a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. Areas Covered Part 11 / Annex 11 Computer Systems Validation (CSV) is be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets. It will address the following topics: For more information about this conference visit https://www.researchandmarkets.com/research/hdtslk/2_days_workshop Media Contact: Research and Markets
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