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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.
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
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