Sample management

Adequate sample management policy is an essential piece of a GxP compliant test facility.

Features of the IBR Inc. sample management are:

  • Specific SOP describing the process of sample management from sample entry to sample storage and disposal according to the suggestion of the A5 team of the Global Bioanalysis Consortium (GBC)
  • Central monitoring system (CMS) that includes the temperature of rooms, refrigerators, freezers and ultra-freezers including redundant alarm system by cell phone and Email
  • 21 CFR Part 11 compliant sample and reagent management data base
  • Defined workflow for sample processing and information management accompanying the project work flow

The sample management follows the best practices for biorepositories by J.B. Vaught and M.K. Henderson Unit 2; Chapter 3 Biological sample collection, processing, storage and information management.

The quality system of IBR Inc. ensures transparent conduction of studies from planning, to laboratory execution and to reporting. IBR Inc. offers a comprehensive validation program for all kind of assays according the ICH Q2 (R1) guidelines.

 

 

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