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21 CFR Part II

21 CFR Part 11

Title 21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic records and electronic signatures. It requires most companies that deal with the FDA, such as pharmaceutical companies and medical device manufacturers, to implement controls that ensure the integrity of their documents. Since most data analyzed in Statgraphics come from data sources external to the program, we recommend that users implement a file or source control system such as SmartShell from Velquest which provides a wrapper around all applications, including Excel, Word, and Statgraphics. It monitors all traffic on the computer and redirects documents to a secure location, where they cannot be overwritten. To modify a file (such as a Statgraphics StatFolio), users must enter their electronic signature and a reason for the modification. The control system maintains an audit trail for later review. Version 16 of Statgraphics Centurion added the ability to save the XML script associated with a StatFolio. It is recommended that these scripts be saved together with the StatFolio, since they show the data source(s), the procedures applied, and all options.


Title 21 CFR Part II


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