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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:
< 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.