IQ/OQ/PM Services
Installation qualification, operational qualification, preventive maintenance, and repair coverage for microplate readers and washers
Preserve instrument documentation in a digital and compliant format
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.
Features
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Installation Qualification (IQ)
Verifies and documents that all necessary components required for operation are received and properly installed in accordance with Molecular Devices installation protocols.
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Operational Qualification (OQ)
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.
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Preventive Maintenance (PM)
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.
Assure data integrity and compliance with confidence
Our comprehensive suite of proven compliance solutions for GMP/GLP labs can advance your efforts to quickly and confidently establish a compliant laboratory.
- Best-in-class microplate readers and washers support all your assay needs
- IQ/OQ/PM services preserve instrument documentation in a digital and compliant format
- Software installation services verify and document that required components are installed to operational specifications
- Software validation service supports FDA 21 CFR Part 11 and EudraLex Annex 11 guidelines
- Validation plates test the performance of your microplate reader using traceable materials for reliable results
Latest Resources
![[Podcast] Challenges of traditional cell line development and emerging technologies to help regulate monoclonality](/sites/default/files/2022-09/monoclonality-assurance-cell-line-development.jpg)
Resources of IQ/OQ/PM Services
Blog
[Podcast] Challenges of traditional cell line development and emerging technologies to help regulate monoclonality
[Podcast] Challenges of traditional cell line development and emerging technologies to help regulate monoclonality
Advancements in genetic engineering and synthetic biology have allowed numerous breakthroughs in recent decades. The importance of cell line development needs an honorable mention.…
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Blog
FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs
FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs
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
GxP regulated industry assessments of SoftMax Pro Software
GxP regulated industry assessments of SoftMax Pro Software
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…
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White Paper
GxP regulated industry assessments of microplate readers
GxP regulated industry assessments of microplate readers
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
Instrument validation services
Instrument validation services
Installation, operational qualification, preventive maintenance
Assure ongoing compliance of your Molecular Devices microplate readers and washers and be audit ready with compr…
Brochure
GxP compliance solutions for GMP/GLP labs
GxP compliance solutions for GMP/GLP labs
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
Streamline your compliance journey in GMP/GLP labs
Streamline your compliance journey in GMP/GLP labs
Comprehensive OEM operational qualification and repair coverage for microplate readers and washers.
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Flyer
Service plans to maximize your productivity
Service plans to maximize your productivity
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
Molecular Devices introduces enterprise-level SoftMax Pro 7.1 GxP Software
Molecular Devices introduces enterprise-level SoftMax Pro 7.1 GxP Software
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;…
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Brochure
SoftMax Pro 7.1.2 GxP Data Acquisition and Analysis Software
SoftMax Pro 7.1.2 GxP Data Acquisition and Analysis Software
Meet FDA guidelines in GMP/GLP labs with complete validation tools.
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Brochure
Software compliance for GMP/GLP labs
Software compliance for GMP/GLP labs
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
SpectraTest Validation Packages
SpectraTest Validation Packages
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
