See each ALCOA+ principle, Attributable through Available, side by side on paper and in electronic records, so the whole team reads the same standard in both columns.
Connect 21 CFR Part 11 to the ALCOA+ you already learned. Each electronic-records row points to the Part 11 section behind it, so the rule stops feeling like a separate set of requirements.
Keep it as a quick reference when you're reviewing records, training new staff, or prepping for an inspection, whether you're a coordinator, investigator, or sponsor.
ALCOA+ on paper and electronic records, in one place.
This printable lays the nine ALCOA+ principles side by side with what each one looks like on paper and in electronic records, with the matching 21 CFR Part 11 section noted for the electronic side. Good documentation practices already teach ALCOA+. This guide shows the part most training skips: paper meets that standard by its physical nature, and Part 11 is how the same standard gets rebuilt for electronic records. It also flags the one place paper is genuinely weaker, disaster and redundancy, where the regulations don't fully close the gap. Whether you're a new coordinator, a student, an investigator, or a sponsor, it connects two ideas that usually get taught separately, so you can look at any Part 11 requirement and trace it straight back to the principle it protects. Keep it in your regulatory binder, training packet, or onboarding materials, it's the kind of one-pager you'll reach for more than once. Licensed for individual or single-site use. Full licensing details can be found at catalog.cliniq.academy/pages/license-agreement.
Ready to go deeper on Part 11?
This guide shows how ALCOA+ carries from paper into electronic records. When you're ready for the full picture, the 21 CFR Part 11 Site Resource walks through the whole rule in plain language, providing sites with a framework to gauge their understanding of the regulation and their compliance with it. Look for it under Tools in the ClinIQ Academy catalog at catalog.cliniq.academy.
See how paper and electronic records meet the same principles.
ALCOA+ is the backbone of every regulated record. Get the side-by-side reference that connects it to Part 11 and keeps the two straight in your head.
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