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. Due to the variability and complexity of sample analyses in FDA laboratories, analytical Spreadsheet applications are often modified or created in actual time, as an analyst performs the analytical procedure.

DFS/ORA Laboratory Information Bulletin No. 4349 Software Verification Page 2 of 25 personal use. The individual analyst can perform data entries and modifications to handle raw and secondary data.

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  Design, Verification, Laboratory, Validation, Spreadsheets, Spreadsheet design, Verification and validation

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