SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 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.
The system audit trail tracks all changes including date and time stamps, username, user ID, section statements, signature information and read results.
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.
Maintaining data integrity compliance in a regulated GxP environment
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.
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.
Users can only sign a single pre- and post-release statement per document contributing to data integrity.
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.
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.
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.
Our comprehensive suite of proven compliance solutions for GMP/GLP labs can advance your efforts to quickly and confidently establish a compliant laboratory.
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.
This Market Requirements Assessment document is designed from supplier audit questionnaires to address SoftMax® Pro Data Acquisition and Analysis – GxP Edition Software as suitable c…
The pharmaceutical world is a highly regulated environment. And for good reason. As a potential drug moves through the development process – from the in vitro discovery phase, to pre…
SoftMax Pro GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity.…
Our Customer Support team is the initial point of contact for general questions about our software and reporting of any incidents.
Support is delivered by a multi-region team…
Our SoftMax® Pro GxP Software Suite can scale up from a single computer to a global networked environment. Our Professional Services team will partner with your IT team to plan and i…
Evaluating microplate readers doesn’t have to be overwhelming. First, consider your application needs. If your budget is modest, a single-mode reader dedicated to your main applicati…
The regulations for food and drug in the United States, described in the Title 21 of the Code of Federal Regulations, and the EudraLex Annex 11 in EU, are critical in ensuring safe…
SoftMax® Pro GxP Software is the latest, most secure software to help you achieve full FDA 21 CFR Part 11 compliance with streamlined workflows to ensure data integrity. Every step i…
Get remote PhD level technical support from the experts that know our microplate readers and SoftMax® Pro GxP Software best. Only Molecular Devices SMPCare provides one-stop support…
This document outlines references to 21 CFR Part 11 and EudraLex Annex 11 and how they apply to the implementation of SoftMax® Pro GxP Data Acquisition and Analysis Software in regul…
This document outlines references to 21 CFR Parts 58, 211 and 820 and EudraLex Annex 15 to assess the implementation of Molecular Devices microplate readers in regulated environments…
Installation, operational qualification, preventive maintenance
Assure ongoing compliance of your Molecular Devices microplate readers and washers and be audit ready with compr…
Molecular Devices is a leader in comprehensive compliance solutions with microplate detection systems and software. Combined with validation services and support, our solutions assur…
Comprehensive OEM operational qualification and repair coverage for microplate readers and washers.
Our on-site SoftMax® Pro GxP Software validation service supports FDA 21 CFR Part 11 guidelines and is conducted by our certified Field Service Engineer (FSE). Each step in the proce…
Each instrument’s functional level will evolve over its operational life cycle—changing with the laboratory environment, assay conditions, usage, role in experimental workflow, compl…
The SoftMax® Pro GxP Software Suite can scale from a single computer to a networked environment of multiple computers. Consult with your Molecular Devices representative and your networ…
For researchers working in GLP or GMP laboratories, the SoftMax® Pro Software Validation Package provides the most comprehensive documentation and tools available to validate GxP pro…
Microplate readers from Molecular Devices are designed to provide consistent performance for many years. In keeping with best practices, reader performance should still be validated…
Biological assays are frequently analyzed with the help of parallel line analysis (PLA). PLA is commonly used to compare dose-response curves where there is no direct measurement of a…
SoftMax® Pro GxP Software is our latest generation software that supports 21 CFR Part 11 and Annex 11 compliance for GMP/GLP regulated labs
Maintaining data integrity compliance in a regulated GxP environment
GxP compliance solutions for GMP/GLP labs
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
Latest Citations: For a complete list, please click here .
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.
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.
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.
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.
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.
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.
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.
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 *|
|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