The purpose of the MHRA document is to provide GLP test facilities with guidance on what should be considered when implementing a risk based GLP Quality Assurance (QA) programme. This document discusses the expectations of the UK GLP Monitoring Authority related to the use of a risk based QA programme and includes information on quality control activities that may be used to support it.
For example, where a manual transcription process is in place the introduction of a QC check at the time of transcription increases the detectability of any errors and reduces the risk of incorrect data being used in a calculation. In this specific case the use of a validated computerised system would further reduce the residual risk, where direct transfer of data from one system to another may be performed without the need for additional QC checks.