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SigmaPlot Compliance with FDA Title 21 CFR Part 11

Software Validation

Systat Software Inc. is committed to developing state-of-the-art software that enhances and improves the quality of scientific research. Systat Software Inc. is the only scientific software company that offers a full range of scientific and engineering tools designed to meet the special needs of research scientists and engineers. Below is a summary of the procedures used by Systat Software Inc. for developing and assuring high quality software for SigmaPlot and related products.

SigmaPlot Software Validation Document (PDF)

Password protection of data and macros:

To ensure security of notebook contents, you can lock notebooks using a password. This is particularly useful if two or more users are using the same version of SigmaPlot. You can also use a password to send confidential data to other SigmaPlot users.

Displaying Password Protected Data

You can save your graphs in high resolution and then later publish them on the Internet using the SigmaPlot WebViewer.

Saving your graphs as a web page creates HTML code that you can later import into any HTML editor.

You can secure your data for a graph you export to an HTML file by setting a password for viewers to enter when viewing this graph on the Internet. Setting a password also prevents the opening and downloading of this file.

When you export a graph to the Web, SigmaPlot automatically creates three files:

  • A notebook .JNB file which contains the SigmaPlot graph and data worksheet.
  • A JPEG of the graph, viewable by those who do not have the SigmaPlot WebViewer.
  • An HTML file which references a .JPG of the graph and the .JNB file.

You can export an entire graph page or other pasted objects.

Time-stamped Audit Trail Capability

Use SigmaPlot Auditing to create a record showing who has modified and saved a Notebook file and what operations he or she has performed during a given period of time.

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 manual testing. Also the macro language provides the mechanism for repeatable "hands-off" analysis of instrumentation data.

SigmaPlot from version 9.0 and above have 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.

 



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