WEEK 33 · INSTRUMENT 3 LABDOCS, PART 1

Do one thing.
Then you are ahead.

Think of a bank vault ledger from the days before computers: each line written in ink, numbered, dated, signed, and never erased; a mistake is struck through with a single line and initialled. That is ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, plus complete, consistent, enduring, available), and 21 CFR Part 11 is the rule that says an electronic record must behave like that ledger. This week…