Quality Assurance:

Mission: Quality biology support to discovery organisations

• Independent department led by experienced professional to ensure that the studies performed follow the principles of GLP
• Establishing and maintaining appropriate quality systems for various types of work
• Created a defined system that includes independent personnel familiar with the test procedures, standards and systems
• QA role -
  • Identification, development and control of SOPs
  • Control and maintenance of documentation
  • Auditing of lab books
  • Verification of the study plan and amendments when they arise
  • Conduction of the process and study based inspections for all research activities performed
  • Routine inspection of the various systems of the facility
  • Auditing of the final reports and signing of a QA Statement

  Data guidelines -

  • The data generated at Chembiotek is analysed by our Quantitative Biology group comprising of a statistician and an IT professional
  • Independent analysis of raw data provides an internal quality check and a standardisation of reporting results
  • We follow the guidelines for generation of quality data outlined in the NIH Roadmap to Discovery
  • Each Assay goes through a validation phase
  • Cell based Assays go through a variability analysis
  • Statistical parameters generated for data sets
  • Software tools developed to minimise cut-paste errors and to speed up data analysis