 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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