Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
What’s in a name? Depending on industry, a word can have very precise meaning. Look up the word “deviation” on the internet and the first definition to appear reads: noun, The action of departing from an established course or accepted standard. Statisticians use the term to define “The act of deviating” or “Deviation from a norm”.
If you search for the definition of “deviation” as applied in the Pharmaceutical industry, you’ll find some variation of “Unexpected departure from an approved instruction, procedure, established standard or specification.” In other words, “deviation” is not a desirable term in the Quality lexicon. (more…)