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.
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.View microplate readers
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.
The SpectraTest® Validation Plates provide automated, comprehensive, and traceable validation of optical performance, plus automatic verification of our microplate readers.
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).
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.View validation plates
For a single computer setup or a network setup, user accounts, data, and the audit trail information are stored in a Microsoft SQL database.
Our technical support team will remotely walk you through the installation.
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.
Verifies and documents that all necessary components required for operation are received and properly installed in accordance with Molecular Devices operational specifications.
Tests the mechanical, electrical, and optical components of each instrument to verify proper operating functions in accordance with manufacturer specifications.
Ensures each instrument meets operational specifications through comprehensive, multipoint inspection. The instrument is calibrated, inspected, and lubricated. Potential issues are proactively addressed.
Each instrument’s functional level will evolve over its operational life cycle; we offer several levels of field and depot service plans designed to deliver paramount performance and productivity, with a predictable cost-of-ownership.
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.