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Quality Assurance

The BioVendor Analytical Testing Service has developed a system of reception of materials, which excludes the risk of loss, confusion or destruction of samples.

Transport

Transport of samples is carried out through carriers, that enable monitoring of shipments. Transport of samples can be carried out in the backup mode. The same samples are transported in two successive terms, usually with a daily or weekly delays.

Receipt of delivery

Samples are received by warehouse worker and forwarded to the service manager or trained staff. Receipt of the samples is recorded in the form, that contains the following information:

  • date of delivery
  • number of samples
  • consigner (customer)

Labeling

All samples are identified by code numbers, which do not contain personal identification number, diagnosis, or other sensitive data on individual patients.

Storage

Samples are stored in dedicated deep freezer box at -70 ° C. Storage can be carried out in the backup mode. The same samples are stored in two independent deep freezer boxes.

The BioVendor’s Department of Quality Assurance ensures complete oversight of all projects. Over the course of a project, we monitor intra-assay and inter-assay performance by using Quality Control High and Quality Control Low on each plate (run). Results are presented as intra-assay and inter-assay coefficients of variation (CV) calculated according to the formula: Expected / Obtained and expressed as a %. These outputs are available in both the Analytical (Validation) and Final Report.

  • Routine internal audits and inspections
  • Data audited for integrity and reliability
  • Security measures to ensure electronic data retrieval
  • Inspections to assure compliance to protocols and laboratory SOP's
  • Access to reports limited to authorized personnel
  • Use of serum based Quality Controls (High and Low)
  • Availability of Internal Quality Controls (IQC1, IQC2, IQC3, IQC4) in case of any need for referee measurements