Laboratories operating under GMP (good manufacturing practice) and GLP (good lab practice) regulations must follow FDA or regional regulatory 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 operational specifications and that the data acquisition and analysis software complies with regulations for electronic recordkeeping.
Molecular Devices is a leader in comprehensive compliance solutions with microplate detection systems and software. Combined with validation services and support, our solutions assure data integrity.
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 readers come equipped with our industry-leading SoftMax® Pro GxP Software—making us your partner in compliance.View products
IQ/OQ services and PM/OQ service plans preserve instrument documentation in a digital and compliant format. Ensure ongoing compliance of your Molecular Devices microplate readers and be audit ready with comprehensive validation, maintenance, and repair documentation
Verifies and documents all necessary components required for operation are received and properly installed in accordance with Molecular Devices installation protocols.
Tests every subsystem of the reader or washer including mechanical, electrical, and optical components to verify operating functions are in accordance to the Molecular Devices product operational specifications
Each plate reader or washer is calibrated, inspected, and lubricated—any potential issues are proactively addressed. Our comprehensive multipoint inspection and testing ensures each microplate reader or washer meets our product operational specifications.
To maintain confidence in the standards, we recommend having validation plates recertified at one-year intervals.
All test measurements and calculations are handled automatically by the SoftMax Pro GxP Software protocols. Should any of the measurement parameters fall outside defined limits, a test failure is reported with the suspect parameters identified.
Our validation plates are traceable to National Institute of Standards and Technology (NIST) and National Metrology Institutes (NMIs).
Validation plates sent to us are cleaned, calibrated, and recertified according to ISO 17025 (ABS1, FL1, and LM1 plates), and returned with a new certificate of calibration
SoftMax Pro 7.1.1 GxP Software is our most secure software to help you 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 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 guidelines and is conducted by our certified Field Service Engineer (FSE). Each step in the process will be carefully planned and executed.
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.