Under 21 CFR 117.305, records may be originals, true copies or electronic; they must capture the actual values and observations; be accurate, indelible and legible; be created when the activity happens; and be as detailed as needed to show what was done. They must include the facility name (and location when necessary), the date (and time when appropriate), the signature or initials of the person who did the activity and, where appropriate, the product and lot code.
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