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Key words: SigmaPlot 5.0, SigmaPlot 5, SigmaPlot 5.0, Sigma Plot 5, Sigma Plot 5.0
SigmaPlot 9.0 (upgrade from 5.0)
21 CFR Part 11 Compliance
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
8.0 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.
As part of an incremental plan for implementing Part 11, SigmaPlot
8.0 has the capability of reading MS Access databases. This is the beginning of an interaction with database technology that will allow implementation of important security and audit trail requirements.
The remaining requirements will be added in subsequent SigmaPlot releases. We are working with our customers to design and implement these features so that their needs are satisfied.
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