The truth is, lot tracking is more tangential to what FDA CFR Part 11 is all about, and far from being the
pith of the matter. Yes, you must address lot tracking to be FDA-compliant, because lot tracking with integrity is an essential part of FDA-mandated GMPs.
As argument about the sacrament proceeded at mid-century in Reformation England, there was general agreement, according to Cranmer, the reform-minded Archbishop of Canterbury, that "the very
pith of the matter, and the chief point whereupon the whole controuersy hangeth, [is] whether in these words, 'This is my body,' Christ called bread his body." Cranmer noticeably shifts the issue from being to calling, from object to language, truth to interpretation.