Spreadsheet Design and Validation for Regulatory ...

DFS/ORA Laboratory Information Bulletin No. 4317 Software Validation Page 1 of 40 Spreadsheet Design and Validation for the Multi-User Application for the Chemistry Laboratory Part I by Dennis Cantellops, Evelyn Bonnin and Anne Reid Southeastern Regional Laboratory Introduction Two LIB s covering Design and Validation of analytical spreadsheets have been prepared. This document covers the general principles of Spreadsheet application to be employed by several users (multi-users), Part I. Another document to be submitted, Part II concentrates on spreadsheets to be used by only one user (single-user). The Design aspects of spreadsheets and the verification and Validation documentation for reporting in a Regulatory environment are discussed.

These analytical spreadsheet mistakes can be eliminated if the analyst (developer) ensures that each element in the spreadsheet application is uniquely and unambiguously defined. As a minimum, a simple spreadsheet validation documentation should include the following items (3): • A description of what the program does and proper instructions.

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  Design, Validation, Spreadsheets, Spreadsheet design and validation for, Validation spreadsheet

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