21 CFR 11 Compliance for the FDA

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Jay Arthur
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KnowWare International, Inc.
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1. Be Validated
2. Be Secure from unauthorized changes
3. Have an audit trail of changes

Validation: The QI Macros and templates are tested against a wide variety of texts and other SPC software. For further information about our software validation process see http://www.qimacros.com/validation.html

Security and Audit Trail: The QI Macros are written to run in native Excel, so they do not supply any of these features other than what Excel supplies.

We recommend that you purchase a separate package to manage these key aspects of compliance for Excel. Consider: Data Compliance System (DaCS) from Wimmer Systems and ABB: http://www.spreadsheetvalidation.com.

Once you have this Excel add-in installed, you can:

1. Run the QI Macros charts on your data or
2. Open and update the QI Macros templates or
3. Run the Anova analysis tools on your data
4. and then save it as an Excel workbook under DaCS control.

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