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Maintaining data integrity compliance in a regulated GxP environment

Become compliant with FDA part 11 software validation

SoftMax® Pro 7.1.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.

Our expert team will partner with you to set up single- or enterprise-level software, and provide IQ OQ services using our validation package to establish full compliance on your microplate readers. Major data privacy and security improvements support the latest GDPR regulations.

See how SoftMax Pro GxP Compliance Software meets 21 CFR Part 11 and EU GMP Annex /11 requirements.

  • Track and record all changes

    Track and record all changes

    The system audit trail tracks all changes including date and time stamps, username, user ID, section statements, signature information and read results.

  • Maintain data integrity

    Maintain data integrity

    The paperless, document status system maintains data integrity with control over eSignatures and document workflows. Project teams can track documents while they are moving through development, review, release, and usage in a controlled environment.

SoftMax Pro 7.1 GxP Software

GxP compliance software features

  • Protocol Icon

    Windows Active Directory

    User administration in a Windows Active Directory or via the GxP Admin software simplifies defining password criteria, reset and change periods, and reduces the amount of IT support.

  • Improved Functionality Icon

    Improved auto-save functionality

    New documents must be saved before they can be modified and documents are automatically saved before and after a read to prevent the loss of data.

  • Improved Signing Icon

    Improved signing process

    Users can only sign a single pre- and post-release statement per document contributing to data integrity.

  • Projects Icon

    Projects feature

    Project teams can be created where users can be assigned to different projects with different roles but can't have different roles in the same project.

  • Roles and Permissions Icon

    Roles and permissions

    Permissions are defined on a per role basis and assigned accordingly to users within projects to maintain a structured system. Three predefined roles—Scientist, Lab Manager, Lab Technician—accommodate the document release workflow, allowing first-time users to get started quickly.

  • Validation Icon

    Auto-export function

    Data can be exported to a location outside the database and various file formats are available to support the import into other applications such as LIMS (Laboratory Information Management System) or SDMS (Scientific Data Management System). XML is supported for data export and auto export.

Proven GxP solutions to assure data integrity and compliance

Our comprehensive suite of proven compliance solutions for GMP/GLP labs can advance your efforts to quickly and confidently establish a compliant laboratory.

  • Best-in-class microplate readers and washers support all your assay needs
  • IQ/OQ/PM services preserve instrument documentation in a digital and compliant format
  • Software installation services verify and document that required components are installed to operational specifications
  • Software validation service supports FDA 21 CFR Part 11 guidelines
  • Validation plates test the performance of your microplate reader using traceable materials for reliable results
GxP compliance solutions for GMP-GLP labs

 

Applications of SoftMax Pro GxP Software

Specifications & Options of SoftMax Pro GxP Software

 

Helpful Tips:

  • To prevent data loss, turn off all sleep and hibernation settings for the hard disk, the CPU, and the USB ports
  • Disable automatic Windows Updates
  • Update Windows manually when the instrument isn't being used by the software; these options can be enabled in Windows Control Panel

Note: Installing and using the SoftMax Pro Software on the Windows XP operating system is no longer supported. The software is neither tested nor validated on Windows XP.

Resources of SoftMax Pro GxP Software

Presentations
Videos & Webinars
Maintaining data integrity compliance in a regulated GxP environment

Maintaining data integrity compliance in a regulated GxP environment

Week 5 Video Thumbnail

Urban myths of microplate readers: Read-Copy-Paste-Analyze. Repeat... Sound familiar?

Week 4 Video Thumbnail

Urban myths of microplate readers: Beyond the basics - real time, resolving time and transferring energy

Week 3 Video Thumbnail

Urban myths of microplate readers: “Optimization? But the manual says I need to be excited at 490nm!"

 Week 1 Video Thumbnail

Urban myths of microplate readers: OD, RFU or RLU - What exactly are they and why bigger is not always better!

Week 2 Video thumbnail

Urban myths of microplate readers: Which microplate reader? Decisions, decisions and how to be less confused!

GxP compliance solutions for GMP-GLP labs

GxP compliance solutions for GMP/GLP labs

How a complete set of software and validation tools

How a complete set of software and validation tools for microplate readers can help GMP/GLP labs meet FDA data integrity guidelines

SoftMax Pro 7.1 GxP Software

SoftMax Pro GxP Software compliance for microplate readers

  • Citation
    Dated: Apr 23, 2021
    Publication Name: Nature Protocols

    Quantification of SARS-CoV-2 neutralizing antibody by wild-type plaque reduction neutralization, microneutralization and pseudotyped virus neutralization assays

    Virus neutralization assays measure neutralizing antibodies in serum and plasma, and the plaque reduction neutralization test (PRNT) is considered the gold standard for measuring levels of these antibodies for many viral diseases. We have developed procedures for the standard PRNT, microneutralization assay (MNA) and pseudotyped virus… View more

    Virus neutralization assays measure neutralizing antibodies in serum and plasma, and the plaque reduction neutralization test (PRNT) is considered the gold standard for measuring levels of these antibodies for many viral diseases. We have developed procedures for the standard PRNT, microneutralization assay (MNA) and pseudotyped virus neutralization assay (PNA) for severe acute respiratory syndrome coronavirus 2. The MNA offers advantages over the PRNT by reducing assay time, allowing increased throughput and reducing operator workload while remaining dependent upon the use of wild-type virus. This ensures that all severe acute respiratory syndrome coronavirus 2 antigens are present, but Biosafety Level 3 facilities are required. In addition to the advantages of MNA, PNA can be performed with lower biocontainment (Biosafety Level 2 facilities) and allows for further increases in throughput. For each new vaccine, it is critical to ensure good correlation of the neutralizing activity measured using PNA against the PRNT or MNA. These assays have been used in the development and licensure of the ChAdOx1 nCoV-19 (AstraZeneca; Oxford University) and Ad26.COV2.S (Janssen) coronavirus disease 2019 vaccines and are critical for demonstrating bioequivalence of future vaccines.

    Contributors: Kevin R. Bewley, Naomi S. Coombes, Luc Gagnon, Lorna McInroy, Natalie Baker, Imam Shaik, Julien R. St-Jean, Natalie St-Amant, Karen R. Buttigieg, Holly E. Humphries, Kerry J. Godwin, Emily Brunt, Lauren Allen, Stephanie Leung, Phillip J. Brown, Elizabeth J. Penn, Kelly Thomas, Greg Kulnis, Bassam Hallis, Miles Carroll, Simon Funnell & Sue Charlton  
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  • Citation
    Dated: Dec 15, 2020
    Publication Name: Vaccine

    Development and characterization of a standardized ELISA including a reference serum on each plate to detect antibodies induced by experimental malaria vaccines

    Enzyme linked immunosorbent assay (ELISA) has been widely used to measure antibody titers for evaluating the immunogenicity of a vaccine. However, there is as yet no generally accepted way of expressing the ELISA results in the case of experimental vaccines, since there is usually no uniform standard. Both end point and single dilution methods… View more

    Enzyme linked immunosorbent assay (ELISA) has been widely used to measure antibody titers for evaluating the immunogenicity of a vaccine. However, there is as yet no generally accepted way of expressing the ELISA results in the case of experimental vaccines, since there is usually no uniform standard. Both end point and single dilution methods have significant disadvantages. In this paper, we obtained reproducible data with fewer dilutions of samples by addition of serially diluted standard serum to each ELISA plate. Since this ELISA method gives reliable antibody titer with less labor than other methods, it can strongly support vaccine development.

    Contributors: Kazutoyo Miura, Andrew C. Orcutt, Olga V.Muratova, Louis H.Miller Allan, Saul, Carole A. Long  
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  • Citation
    Dated: Aug 19, 2020
    Publication Name: bioRxiv

    NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways 3 against SARS-CoV-2 challenge

    There is an urgent need for a safe and protective vaccine to control the global spread of SARS-CoV-2 and prevent COVID-19. Here, we report the immunogenicity and protective efficacy of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length SARS-CoV-2 spike (S) glycoprotein stabilized in the prefusion conformation. View more

    There is an urgent need for a safe and protective vaccine to control the global spread of SARS-CoV-2 and prevent COVID-19. Here, we report the immunogenicity and protective efficacy of a SARS-CoV-2 subunit vaccine (NVX-CoV2373) produced from the full-length SARS-CoV-2 spike (S) glycoprotein stabilized in the prefusion conformation.

    Contributors: Mimi Guebre-Xabier, Nita Patel, Jing-Hui Tian, Bin Zhou, Sonia Maciejewski, Kristal Lam, Alyse D. Portnoff, Michael J. Massare, Matthew B. Frieman, Pedro A. Piedra, Larry Ellingsworth, Gregory Glenn, Gale Smith  
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  • Citation
    Dated: Nov 28, 2019
    Publication Name: Springer

    Meeting technical challenges for protein characterization and surrogate equivalence studies that resulted from insecticidal protein co-expression in maize event MZIR098

    Safety assessment of genetically modified plants includes protein characterization to confirm the intended trait protein expression. In addition, to conduct safety tests, the large amount of purified protein needed is usually met through the use of a surrogate, microbially produced protein source. View more

    Safety assessment of genetically modified plants includes protein characterization to confirm the intended trait protein expression. In addition, to conduct safety tests, the large amount of purified protein needed is usually met through the use of a surrogate, microbially produced protein source.

    Contributors: Frederick S. Walters, Scott Young & Gerson Graser
     
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  • Citation
    Dated: Jul 12, 2019
    Publication Name: Nature

    Inside out: optimization of lipid nanoparticle formulations for exterior complexation and in vivo delivery of saRNA

    Self-amplifying RNA (saRNA) is a promising biotherapeutic tool that has been used as a vaccine against both infectious diseases and cancer. saRNA has been shown to induce protein expression for up to 60 days and elicit immune responses with lower dosing than messenger RNA (mRNA). Because saRNA is a large (~9500 nt), negatively charged molecule, it… View more

    Self-amplifying RNA (saRNA) is a promising biotherapeutic tool that has been used as a vaccine against both infectious diseases and cancer. saRNA has been shown to induce protein expression for up to 60 days and elicit immune responses with lower dosing than messenger RNA (mRNA). Because saRNA is a large (~9500 nt), negatively charged molecule, it requires a delivery vehicle for efficient cellular uptake and degradation protection.

    Contributors: Anna K. Blakney, Paul F. McKay, Bárbara Ibarzo Yus, Yoann Aldon & Robin J. Shattock
     
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  • Citation
    Dated: Oct 01, 2018
    Publication Name: Crop Protection

    Identification and characterization of abamectin resistance in Tetranychus urticae Koch populations from greenhouses in Turkey

    The two-spotted spider mite, Tetranychus urticae Koch is one of the most serious pests in greenhouses and has developed high resistance to many classes of acaricides rapidly. Three T. urticae populations were collected from vegetable greenhouses in Antalya and Muğla, Turkey. These populations showed high resistance levels to abamectin ranging… View more

    The two-spotted spider mite, Tetranychus urticae Koch is one of the most serious pests in greenhouses and has developed high resistance to many classes of acaricides rapidly. Three T. urticae populations were collected from vegetable greenhouses in Antalya and Muğla, Turkey. These populations showed high resistance levels to abamectin ranging between 223 and 404 fold compared to a susceptible population. The interaction of some synergists (piperonyl butoxide; PBO, diethyl maleate; DEM and S-benzyl O,O-diisopropyl phosphorothioate; IBP) with abamectin was analyzed showing possible implication of esterases in resistances in the three populations studied. The activities of esterase, glutathione S-transferase (GST) and cytochrome P450 (p450) was determined using α-naphthyl acetate, 1-chloro-2,4 dinitrobenzene (CDNB) and 7-ethoxycoumarin (7-EC) as substrates, respectively. In all field populations, esterase, glutathione S-transferase and P450 activities were higher, when compared to the susceptible population (GSS). The presence of known abamectin resistance target site mutations (G314D and G326E) on the glutamate gated chloride channels was also examined. However, no target site–resistance mutation was detected in all three populations. According to our results, detoxification enzymes, but no target site intensivity seem to play role in abamectin resistance in field T. urticae populations from Turkey.

    Contributors: Naciye Sena Çağatay, Pauline Menault, Maria Riga, John Vontas, Recep Ay  
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  • Citation
    Dated: Apr 04, 2001
    Publication Name: Journal of Investigative Dermatology

    An Alternative Approach to Depigmentation by Soybean Extracts via Inhibition of the PAR-2 Pathway

    The protease-activated receptor 2, expressed on keratinocytes but not on melanocytes, has been ascribed functional importance in the regulation of pigmentation by phagocytosis of melanosomes. Inhibition of protease-activated receptor 2 activation by synthetic serine protease inhibitors requires keratinocyte-melanocyte contact and results in… View more

    The protease-activated receptor 2, expressed on keratinocytes but not on melanocytes, has been ascribed functional importance in the regulation of pigmentation by phagocytosis of melanosomes. Inhibition of protease-activated receptor 2 activation by synthetic serine protease inhibitors requires keratinocyte-melanocyte contact and results in depigmentation of the dark skinned Yucatan swine, suggesting a new class of depigmenting mechanism and agents. We therefore examined natural agents that could exert their effect via the protease-activated receptor 2 pathway. Here we show that soymilk and the soybean-derived serine protease inhibitors soybean trypsin inhibitor and Bowman-Birk inhibitor inhibit protease-activated receptor 2 cleavage, affect cytoskeletal and cell surface organization, and reduce keratinocyte phagocytosis. The depigmenting activity of these agents and their capability to prevent ultraviolet-induced pigmentation are demonstrated both in vitro and in vivo. These results imply that inhibition of the protease-activated receptor 2 pathway by soymilk may be used as a natural alternative to skin lightening.

    Contributors: Christine Paine, Elizabeth Sharlow, Frank Liebel, Magdalena Eisinger, StanleyShapiro, MiriSeiberg  
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Software and installation service

SoftMax® Pro GxP Software: Windows 10 compatible

Latest version of SoftMax Pro 7 GxP Software Suite includes: 3 software installations for each user license, GxP Admin Software, software IO/OQ validation package DVD, user license certificate, compliance certificate

Single computer setup Multi computer setup
Part number: SMP7X GXP SINGLE COMP * Part number: SMP7X GXP SERVER *
Installation service
Part number: SMPGXP-INSTALL1COMP-OS ** Part number: SMPGXP-INSTALLSVR-OS **
Part number: SMPGXP-INSTALLADVSVR-OS (for custom server installation)
Additional user license purchases
Part number: SMP GXP ADD Part number: SMP GXP SVR ADD
*Requires purchase of a minimum of 3 licenses
**Applies to initial purchase only

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