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.
Simplify instrument documentation storage with a digital format
Digital laboratory records for instrument inspection, maintenance, testing, and calibration provide a convenient document storage method aligned with electronic recordkeeping
Satisfy multiple regulatory guidelines for instrument validation and maintenance
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
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.
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.
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
Resources of IQ/OQ/PM Services
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…
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.
Maintaining data integrity compliance in a regulated GxP environment
GxP compliance solutions for GMP/GLP labs