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

    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

    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. Molecular Devices only certifies operational qualification on instruments when performed by a Molecular Devices certified engineer

GxP regulated industry assessments of microplate readers

GxP regulated industry assessments of microplate readers

Features

  • Installation Qualification (IQ)

    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)

    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)

    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
GxP compliance solutions for GMP-GLP labs

 

Latest Resources

14

Resources of IQ/OQ/PM Services

Presentations
Videos & Webinars
Maintaining data integrity compliance in a regulated GxP environment

Maintaining data integrity compliance in a regulated GxP environment

GxP compliance solutions for GMP/GLP labs

GxP compliance solutions for GMP/GLP labs