Primary record is a term that was defined by the MHRA (Medicines and Healthcare products Regulatory Agency, the UK drug regulator) in data integrity guidance issued in 2015. In this instalment of Questions of Quality we explore what this term means in practice, and compare it with raw data in the European Union Good Manufacturing Practices (EU GMPs) and complete data in US Food and Drug Administration (FDA) GMPs. Why can’t we have harmonization of terms?

Before a CDS can be considered capable for use in a regulated laboratory, it must meet a number of requirements.

A risk assessment helps determine the amount of qualification and validation work necessary to show that instruments and computerized laboratory systems are fit for their intended purpose. Here's how to do it.