Regulatory Compliance Program

Beckman Coulter can significantly reduce the time and effort it takes for you to complete an Operational Qualification Plan for your Beckman Coulter instrument systems.

Beckman Coulter has the combination of documentation and support services to simplify the task. Based on the understanding for our customers that compliance is an evolving and often complex process, our approach is to provide consultative support for your specific requirements and processes.

  • Operation Qualification (OQ2) For selected models only:
    A program that helps customers ensure on-going operation qualification of a system. Operation Qualification includes: Performance verification, preventive maintenance and service parts, software verification test and report if applicable, documentation such as Preventive Maintenance Checklist, OQ2 data sheet, service report and instrument decal. OQ2 can be purchased as a reimbursable service.
  • Instrument Certification (OQ3) Available with Total Plus and Support & Grow Agreements for selected models only:
    A convenient solution to meet the demands of regulatory compliance. Instrument Certification includes: Calibrated tools traceable to national standards, comprehensive documentation of calibration protocol, results and acceptance criteria, engineer's training and tools, re-certification after repair when necessary and flexible scheduling options. Available on selected models.