GxP Compliance and Validation Solution

GxP compliance validation tools and services ensure GMP/GLP labs meet FDA data integrity guidelines

Laboratories operating under GMP (good manufacturing practice) and GLP (good lab practice) regulations must follow FDA guidelines to protect data integrity or demonstrate quality assurance of manufactured products. To be GxP compliant, regulated labs using microplate readers in their workflows need to verify that they are functioning within manufacturing specifications and that the data acquisition and analysis software complies with regulations for electronic recordkeeping.

Molecular Devices offers a complete GxP compliance and validation solution for our microplate readers including validation software, tools and services to ensure you are always audit-ready.

Microplate readers for GMP/GLP regulated labs

SpectraMax Microplate Readers

Our SpectraMax microplate readers are the most cited and have advanced protein and cell biology research for over 30 years.

For GMP/GLP regulated labs, the systems come equipped with our industry-leading compliance software, SoftMax® Pro GxP Software—making us your partner in compliance.

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GxP compliance software and validation package for FDA 21 CFR Part 11 compliant work

SoftMax® Pro GxP Software contains everything that is required to set up your plate reader software for FDA 21 CFR Part 11 compliant work. The software stores documents, user accounts, and audit trail information in a Microsoft SQL database.

SoftMax Pro 7.1 GxP—Regular SoftMax Pro application where username and password are required to log in.

SoftMax Pro Validation Package—Provides comprehensive documentation and tools to validate SoftMax Pro Software and GxP Admin features.

GxP Admin Software—Used to create projects, assign teams, administer user accounts, and connect them to the Windows Active Directory system.

Certificate of Licenses—Contains a User License Code that permits you to add as many users in GxP admin as you have ordered. The product key on this sheet allows you to install and activate SoftMax Pro GxP on up to 3 computers for every user (e.g. laptop, office PC).

Certificate of Compliance—Certifies that SoftMax Pro, SoftMax Pro GxP and GxP Admin were tested and verified to be in compliance with all of our internal, applicable manufacturing and quality requirements.

Validation plates for microplate reader help ensure FDA compliance in GMP/GLP labs

The SpectraTest® Validation Plates provide automated, comprehensive, and traceable validation of optical performance, plus automatic verification of our microplate readers.

SpectraTest Validation Plates

Calibration of the plate’s filter standards is accomplished through the use of an instrument traceable to standards such as NIST (National Institute of Standards and Technology).

  • SpectraTest ABS1 Absorbance Validation Plate
  • SpectraTest FL1 Fluorescence Validation Plate
  • SpectraTest LM1 Luminescence Validation Plate
  • Multi-Mode Validation Plate
  • Cuvette Validation Set

Recertification Service

To maintain confidence in the standards, we recommend having validation plates recertified at one-year intervals. Validation plates sent to us are disassembled, cleaned, calibrated, recertified according to ISO 17025, and returned with a new certificate of calibration.

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Citations

Explore our highly cited – 12,300+ – SoftMax Pro, our microplate reader control and data analysis software

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GxP compliance software installation and service

For a single computer setup or a network setup, user accounts, data, and the audit trail information are stored in a Microsoft SQL database.

Stand-alone computer with or
without network access

Network-based enterprise
solution

Our technical support team will remotely walk you through the installation.

Installation Qualification, Operational Qualification, and Preventive Maintenance (IQ OQ PM) services

Compliance assurance digital IQ/OQ/PM services are a unique qualification solution that preserves the documentation of legacy services in a digital and compliant format. Ensure ongoing compliance for your Molecular Devices microplate readers and be audit ready with the up-to-date validation protocols.

IQ

INSTALLATION
QUALIFICATION (IQ)

Verifies and documents that all necessary components required for operation are received and properly installed in accordance with Molecular Devices operational specifications.

OQ

OPERATIONAL
QUALIFICATION (OQ)

Tests the mechanical, electrical, and optical components of each instrument to verify proper operating functions in accordance with manufacturer specifications.

PM

PREVENTIVE
MAINTENANCE (PM)

Ensures each instrument meets operational specifications through comprehensive, multipoint inspection. The instrument is calibrated, inspected, and lubricated. Potential issues are proactively addressed.

Contact our GxP Compliance Solutions Team

The pathway to compliance may seem a daunting task, but we’ve got you covered. From day-to-day performance verification tests to annual preventive maintenance we’ll help ensure continued performance of your reader and be your partner in compliance.