Validation and GxP Compliance for Microplate Readers
Molecular Devices provides many optional tools, in addition to our bench top microplate readers with cuvette port,
for you to have a fully compliant GLP/GMP and FDA 21 CFR Part 11 solution. The tools below will enable you to
significantly shorten your validation time and resources.
Hardware Validation Tools
SpectraTest Absorbance Instrument Validation Package
The SpectraTest™ Absorbance Validation Package is a
complete instrument validation package for SpectraMax®
and VersaMax microplate spectrophotometers, Gemini fluorometers and SpectraMax multimode readers, and is the industry standard for validating optical performance. The SpectraTest Validation Package provides a complete NIST-traceable solution for validating optical performance of Molecular Devices' microplate readers and does it automatically. All test measurements and calculation are handled by
SoftMax® Pro software and summarized in one report. A NIST-traceable
cuvette set is also available to validate the cuvette port. SpectraTest makes it easy for you to be GLP/GM-compliant.
For more details, please see the SpectraTest page.
IQ/OQ/PQ Guidelines
Molecular Devices provides IQ/OQ/PQ guidelines for its spectrophotometers and Liquid handlers. These tools can be used
in a GLP/GMP process when instruments are in stand-alone mode or in automation mode. For more information, please
contact your local sales representative or send an email to support@moldev.com.
Performance Certification
Our on-site field Engineers can certify your spectrophotometer and recalibrate the instrument to factory specs on-site,
reducing down time of your instruments. Please contact your local technical sales person or send an email to
support@moldev.com.
Software Validation Tools
SoftMax Pro Enterprise for Windows or Mac OS*
SoftMax Pro, the industry-leading microplate reader software for MDC
microplate reader systems allows you to completely customize your data collection and analysis. Choose endpoint,
kinetic, or spectral scans; view kinetic and spectral runs in real time; and collect and store data from multiple
plates, cuvettes, graphs, analysis tables, and notes sections in the same data file. You can automate lab processes
with SoftMax Pro software's interprocess messaging features, and export and import data and template information to
and from your LIMS system. SoftMax Pro Enterprise has all features for full FDA 21 CFR Part 11 compliance. In addition,
a complete software validation package is available for SoftMax Pro.
*For version compatibility information for using Mac OS with SoftMax Pro, please see the
SoftMax Pro requirements page. [PDF]
SoftMax Pro Software Validation Package
The SoftMax Pro Validation Package provides comprehensive documentation
and extensive data sets in CD-ROM format to enable you to validate SoftMax Pro software. The SoftMax Pro validation
package is designed to help you achieve GLP and GMP and FDA 21 CFR Part 11 compliance by allowing you to validate
the built-in calculations in SoftMax Pro software's menus and Group table column formulas, as well as your own
custom formulas. For more details, please see the SoftMax Pro Software
Validation Package page.
SoftMax Pro Software Training
Our software team is in the process of standardizing our software training program to qualify your analyst,
technicians and data analysis users to meet your training needs. For information on any of these tools please
talk to your local technical sales representative or send an email to info@moldev.com.
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