Assure consistency and reliability with expert installation and validation services

 

Our software installation services verify and document that required components are installed to operational specifications. SoftMax Pro GxP Software can be installed on a single computer or on a multi-computer networked environment by our expert technical support or professional services team via remote access, respectively.

Our on-site SoftMax Pro GxP Software validation service supports FDA 21 CFR Part 11 and EudraLex Annex 11 guidelines, and is conducted by a certified professional. Each step in the process will be carefully planned and executed.

  • Leave setup to the experts

    Leave setup to the experts

    Trained representatives plan and scale your implementation according to your requirements

  • Leave validation to the experts

    Leave validation to the experts

    Pre-service consultation and comprehensive software validation testing are provided by our certified professionals

GxP regulated industry assessments of SoftMax Pro Software

GxP regulated industry assessments of SoftMax Pro Software

Features

  • Scalable installation

    Scalable installation

    • Installation scales from a single computer to an enterprise solution with multiple computers connected to a database hosted on a central server
    • Installation experts work directly with customer IT experts

  • Complete documentation

    Complete documentation

    After completion of all tests, the FSE provides a complete data package:

    • Completed & signed SoftMax Pro GxP validation document (hard & scanned copy)
    • Results cover page with electronic signature
    • Results template with screenshots of each step
    • IQ report for SoftMax Pro GxP Software
    • Copy of the FSE Training Certificate

  • Pre-service consultation

    Pre-service consultation

    Validation and installation experts provide a pre-service consultation

Assure data integrity and compliance with confidence

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 and EudraLex Annex 11 guidelines
  • Validation plates test the performance of your microplate reader using traceable materials for reliable results
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GxP solutions

 

Latest Resources

18
Millions in FDA Fines and Thousands of Warning Letters: How GxP Compliance Software Can Help Avoid Them

Publications

Millions in FDA Fines and Thousands of Warning Letters: How GxP Compliance Software Can Help Avoid Them

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…

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[Podcast] Challenges of traditional cell line development and emerging technologies to help regulate monoclonality

Blog

[Podcast] Challenges of traditional cell line development and emerging technologies to help regulate monoclonality

Advancements in genetic engineering and synthetic biology have allowed numerous breakthroughs in recent decades. The importance of cell line development needs an…

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Support Plans for SoftMax Pro GxP Software

Brochure

Support Plans for SoftMax Pro GxP Software

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-…

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Sharing data between users has never been more secure

Flyer

Sharing data between users has never been more secure

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…

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FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs

Blog

FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs

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…

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SoftMax Pro 7.1.2 GxP Software FDA guidance

Flyer

SoftMax Pro 7.1.2 GxP Software FDA guidance

SoftMax® Pro 7.1.2 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…

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GxP regulated industry assessments of SoftMax Pro Software

White Paper

GxP regulated industry assessments of SoftMax Pro Software

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…

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GxP regulated industry assessments of microplate readers

White Paper

GxP regulated industry assessments of microplate readers

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…

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Maintaining data integrity compliance in a regulated GxP environment

Videos & Webinars

Maintaining data integrity compliance in a regulated GxP environment

The Science Explorer interviews Timothy Bolus, Compliance Program Manager at Molecular Devices about the importance of regulatory compliance in the laboratory, and the…

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Resources of GxP Software Installation and Validation

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

Maintaining data integrity compliance in a regulated GxP environment

GxP compliance solutions for GMP/GLP labs

GxP compliance solutions for GMP/GLP labs

How can we help advance your next big discovery?

Our highly-qualified teams are on the frontlines with our customers, conducting remote or on-site product demonstrations, webinars, and more to help you solve your tough research challenges. How can we help you today?

I’d like to…

Request a demo

How can we help advance your next big discovery?

Our highly-qualified teams are on the frontlines with our customers, conducting remote or on-site product demonstrations, webinars, and more to help you solve your tough research challenges. How can we help you today?

I’d like to…

Request a demo
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