Walks the Part 11 scope question record by record, so you know what the rule actually covers.
Includes a Gap Map self-assessment that surfaces where your current practices fall short.
Current to FDA's 2024 guidance, in plain language with clear site responsibility.
Start with the question that decides everything.
Part 11 trips up capable people, usually for the same reason: most explanations open with the technology and skip the question that actually decides scope. Does the rule even apply to this record? Get that wrong and you either treat every file on your computer as a Part 11 record, or you miss the ones that count. This packet starts where the confusion does. It works through the scope question one record at a time, shows you what the regulation requires and who's responsible for each piece, then hands you a self-assessment you run against your own site. Seven sections, built to read straight through or open to the one you need: 1. What Part 11 actually is, and the predicate-rule concept everything depends on 2. Whether Part 11 applies to your records, with a three-part scope test and worked scenarios 3. What Part 11 requires, mapped to plain language and organized by who's responsible 4. The Gap Map self-assessment, a question-by-question review of your own practices 5. How to evaluate any system, from a validated EDC to a spreadsheet you built 6. Red flags and when to escalate them 7. A one-page quick reference for when you don't have time for the rest Built for coordinators, PIs, and CRAs, whether you're handed a sponsor's EDC, set up your own tool, or aren't sure which records the rule even touches. This is an educational resource, built to help you ask the right questions and find your own gaps. It doesn't make compliance determinations for your site, and it isn't regulatory advice. Where it surfaces something serious, the next step is a conversation with your sponsor or a qualified consultant. Licensed for individual or single-site use. Full licensing details at catalog.cliniq.academy/pages/license-agreement.
Find your gaps before someone else does.
Add the Part 11 packet to your regulatory toolkit and walk into your next sponsor conversation knowing exactly where your site stands.
$15.00