IQ/OQ/PM services preserve instrument documentation in a digital and compliant format. Ensure ongoing compliance of your Molecular Devices instruments and be audit ready with comprehensive validation, maintenance, and repair documentation.
Digital laboratory records for instrument inspection, maintenance, testing, and calibration provide a convenient document storage method aligned with electronic recordkeeping
Standardized IQ/OQ/PM services performed by certified field service engineers satisfy FDA 21 CFR and EudraLex Volume 4 guidelines for instrument validation and maintenance. Molecular Devices only certifies operational qualification on instruments when performed by a Molecular Devices certified engineer
Verifies and documents that 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.
Our comprehensive suite of proven compliance solutions for GMP/GLP labs can advance your efforts to quickly and confidently establish a compliant laboratory.
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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…
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.
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…
Built on its current, industry-leading data acquisition and analysis software, SoftMax Pro 7.1 GxP Software expands its system audit trail functions to include date and time stamps;…
Meet FDA guidelines in GMP/GLP labs with complete validation tools.
SoftMax® Pro 7.1.2 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…
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…
Maintaining data integrity compliance in a regulated GxP environment
GxP compliance solutions for GMP/GLP labs