Biomarker Testing Service Quality Assurance

R&D Systems Quality Assurance Department provides project oversight for all Biomarker Testing Service studies. All contracts and laboratory standard operating procedures (SOPs) are reviewed and approved by Quality Assurance.

  • For each study, an audit of the data and related documentation is performed to assure data integrity and compliance with protocols, SOPs, and contract requirements.
  • The laboratory is audited annually to assure that personnel training, equipment, and laboratory operations are compliant with established SOPs.
  • In depth study-specific audits are available on request to satisfy applicable regulatory requirements.

All Biomarker Testing Service personnel training is reviewed and documented annually:

  • Quality manual review
  • Safety training
  • Assay training
  • SOP training

Additional training is conducted as required:

  • ISO9001, ISO13485, and Quality Systems Regulations (QSR) training
  • Application of Good Laboratory Practices (GLPs) in a Good Clinical Practices (GCP) Bioanalytical Environment

Equipment & Facilities

R&D Systems Biomarker Testing Service equipment is maintained and calibrated following predetermined schedules.

  • Molecular Devices SPECTRAmax® 190 absorbance plate reader
  • Molecular Devices SOFTmax® Pro software
  • Molecular Devices Lmax Luminometer
  • Automated plate washers
  • < 60 °C freezer with extensive sample storage capability*
  • Additional on-site storage at < -20 °C and < -60 °C can be obtained as required*
  • Equipped with facility-wide back-up power generators for emergency outages

*To ensure temperature stability, all Biomarker Testing Service refrigerators and freezers are equipped with automated temperature monitoring and 24 hour security systems which alert R&D Systems personnel of any significant temperature fluctuation. Back-up generators and freezers are in place.

Biomarker Testing Service

Biomarker Testing Service
Sample Types Tested & Validated Assays
Sample Collection & Shipping Kits
Sample Shipment, Receipt, & Storage
Quality Assurance
Data Generation & Results Reporting
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