When “Optional” Still Means Auditable: Making Sense of 21 CFR Part 11 Software in the Lab
Optional compliance software is one of the easiest features to misunderstand in a spectrophotometer purchase. The base instrument may measure absorbance beautifully, but if the resulting data feed a regulated decision, the question shifts from optical performance to record integrity. That is where 21 CFR Part 11 software enters the conversation. It is not a…