-
neb2 replied to the topic Discussion Topic: Is the DHF a living document? in the forum The Design History File 8 years, 2 months ago
I believe that the DHF should be a living document that reflects the current state of the device. Keeping track of the changes (SOP’S, material, packaging, labeling..etc) and updating the DHF gives an appropriate and up-to-date information to anyone who needs to refer back to it for any given reason. As Chris mentioned, if the DHF is consistent, looking at historical data from a consistent DHF makes it easier to compare data sets.