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.
Our comprehensive suite of proven compliance solutions for GMP/GLP labs can advance your efforts to quickly and confidently establish a compliant laboratory.
Blog
Advancements in genetic engineering and synthetic biology have allowed numerous breakthroughs in recent decades. The importance of cell line development needs an honorable mention.…
Blog
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…
White Paper
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…
White Paper
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…
Flyer
Installation, operational qualification, preventive maintenance
Assure ongoing compliance of your Molecular Devices microplate readers and washers and be audit ready with compr…
Brochure
Molecular Devices is a leader in comprehensive compliance solutions with microplate detection systems and software. Combined with validation services and support, our solutions assur…
Infographic
Comprehensive OEM operational qualification and repair coverage for microplate readers and washers.
Flyer
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…
Publications
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;…
Brochure
Meet FDA guidelines in GMP/GLP labs with complete validation tools.
Brochure
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…
Data Sheet
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