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Validation and Control of Excel Spreadsheets in Regulated Environments

Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for regulated environments. However, with a good knowledge of Excel capabilities combined with good procedures and practices on how to validate and use Excel requirements can be met. For example, the FDA is widely using Excel and complies with its own regulations. Hand-outs : For easy implementation, attendees will receive SOP: Validation of spreadsheet applications SOP: Development and use of spreadsheets in regulated environments Gap analysis/checklist for Macros and Spreadsheet applications

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