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Spreadsheet Design, Verification and Validation, Use and ...
DFS/ORA laboratory Information Bulletin No. 4349 Software Verification Page 1 of 25 Spreadsheet design , Verification and validation , Use and Storage of Single-User Workbook Files in the US FDA Laboratories Part II by Dennis Cantellops, San Juan District Introduction Two laboratory Information Bulletins (LIBs)* covering the design , testing, Verification and validation of spreadsheets have been prepared. Part I covers the general principles of Spreadsheet application to be employed by several users (multi-users). This document (Part II) covers the spreadsheets to be used by single-users. It includes the use and storage of single-user Spreadsheet files, the design aspects of spreadsheets and the Verification and validation documentation for reporting in a regulatory environment. The discussion pertains to applications of the Microsoft Excel Spreadsheet program.
DFS/ORA Laboratory Information Bulletin No. 4349 Software Verification Page 4 of 25 Analytical Spreadsheets and Hand-Written Worksheets; a Comparison When only hand-written paper worksheets (e.g. FDA forms 431, 431a and calculation of results
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