SigmaPlot Compliance with FDA Title 21 CFR Part 11

21 CFR Part 11 is the United States Food and Drug Administration's (FDA) requirement for electronic record keeping. These are the rules under which an electronic document can be considered equivalent to a paper document. In part, this includes software validation, password protection of data and macros, time-stamped audit trail capability, and various password and security measures.

SigmaPlot already satisfies the requirement for in-house validation using a test suite containing over 1400 scripts. Also the macro language provides the mechanism for repeatable "hands-off" analysis of instrumentation data.

SigmaPlot 9.0 and above has the capability of importing data and running SQL queries from various ODBC-compliant databases. The new version also offers the ability to password protect notebooks for submittal to the FDA or other Government agencies that require adherence to security guidelines.