Requirement and implementation, addressed together.
The platform identifies what the regulation requires. The Academy addresses how that requirement is satisfied within a functioning quality system.
Requirement and implementation, addressed together.
21 Regulus AI is connected to TheCGMPAcademy, our FDA compliance e-learning library published under the Inside the FDA Mind imprint.
The platform identifies what the regulation requires. The Academy addresses how that requirement is satisfied within a functioning quality system - the procedures, records, and controls that constitute compliance in practice rather than on paper. Questions arising from the instruction return to the platform, which returns them to the regulation.
Explore the Resources libraryAccuracy is a property of method, not of assertion.
Any platform may claim accuracy. The question a regulatory professional asks is a different one: by what method is that accuracy established, and by what means may it be independently confirmed?
- Attributable
- Every response identifies the Part, Subpart, and Section from which it derives. No content is returned without an attributable origin within Chapter I.
- Legible
- The promulgated text is presented as promulgated. Where interpretation is furnished, it is distinguished from the regulatory language rather than blended into it.
- Contemporaneous
- Content is monitored against the official source and updated as amendments are published. Each response indicates the currency of the text upon which it relies.
- Original
- The corpus derives from the regulation itself rather than from secondary treatment of it. The platform reports the source, not a report of the source.
- Accurate
- Verification against FDA.gov precedes incorporation, without exception, and performance against a documented acceptance benchmark is recorded prior to release.
These are the attributes your data integrity programme already requires of every record you retain. We saw no reason a regulatory reference should be held to a lesser standard.
The whole of Title 21, Chapter I.
Regulated organisations rarely operate within a single Subchapter. A combination product raises questions under Subchapter H and Subchapter C simultaneously. A contract manufacturer may hold obligations under Parts 210 and 211, Part 820, and Part 117 within a single facility. The platform was accordingly built to the full extent of Chapter I, so that a question may be pursued wherever the regulation takes it - and answered to the same verified standard in every Part.
| Subchapter | Parts | Scope |
|---|---|---|
| Subchapter A1 - 99 | 1 - 99 | General |
| Subchapter B100 - 199 | 100 - 199 | Food for Human Consumption |
| Subchapter C200 - 299 | 200 - 299 | Drugs: General |
| Subchapter D300 - 499 | 300 - 499 | Drugs for Human Use |
| Subchapter E500 - 599 | 500 - 599 | Animal Drugs, Feeds, and Related Products |
| Subchapter F600 - 680 | 600 - 680 | Biologics |
| Subchapter G700 - 799 | 700 - 799 | Cosmetics |
| Subchapter H800 - 898 | 800 - 898 | Medical Devices |
| Subchapter I900 | 900 | Mammography Quality Standards Act |
| Subchapter J1000 - 1040 | 1000 - 1040 | Radiological Health |
| Subchapter K1100 - 1150 | 1100 - 1150 | Tobacco Products |
| Subchapter L1210 - 1299 | 1210 - 1299 | Regulations Under Certain Other Acts Administered by the FDA |
Audit the platform before you adopt it.
Put to 21 Regulus AI a question to which you already know the answer, in an area in which you have practised for years. Follow the citation to the official text. Confirm the response against the source. This is the standard to which the platform was constructed, and the only demonstration that carries weight with a professional audience.
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