diff --git a/apps/console/public/data/frameworks/21CFR-part11.json b/apps/console/public/data/frameworks/21CFR-part11.json
new file mode 100644
index 000000000..54971b54e
--- /dev/null
+++ b/apps/console/public/data/frameworks/21CFR-part11.json
@@ -0,0 +1,71 @@
+{
+ "id": "21 CFR Part 11",
+ "name": "21 CFR Part 11",
+ "logo": {
+ "light": "",
+ "dark": ""
+ },
+ "controls": [
+ {
+ "id": "P11-001",
+ "name": "System Validation",
+ "description": "Systems are validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records."
+ },
+ {
+ "id": "P11-002",
+ "name": "Audit Trails",
+ "description": "Secure, computer-generated, time-stamped audit trails independently record operator entries and actions."
+ },
+ {
+ "id": "P11-003",
+ "name": "Record Retention",
+ "description": "Electronic records are protected to enable accurate and ready retrieval throughout the records retention period."
+ },
+ {
+ "id": "P11-004",
+ "name": "Access Controls",
+ "description": "System access is limited to authorized individuals with unique user IDs."
+ },
+ {
+ "id": "P11-005",
+ "name": "Electronic Signatures",
+ "description": "Electronic signatures are unique to an individual and verifiable."
+ },
+ {
+ "id": "P11-006",
+ "name": "Signature Linking",
+ "description": "Electronic signatures are permanently linked to their respective electronic records."
+ },
+ {
+ "id": "P11-007",
+ "name": "Signature Integrity",
+ "description": "Electronic signatures cannot be excised, copied, or transferred to falsify an electronic record."
+ },
+ {
+ "id": "P11-008",
+ "name": "Signature Binding Enforcement",
+ "description": "System enforces technical and procedural controls to maintain binding between record content and signature."
+ },
+ {
+ "id": "P11-009",
+ "name": "Operational Checks",
+ "description": "Operational system checks enforce permitted sequencing of steps and events."
+ },
+ {
+ "id": "P11-010",
+ "name": "Authority Checks",
+ "description": "Authority checks ensure only authorized individuals can use the system or sign records."
+ },
+ {
+ "id": "P11-011",
+ "name": "Device Checks",
+ "description": "Device checks determine the validity of the source of data input."
+ },
+ {
+ "id": "P11-012",
+ "name": "Training",
+ "description": "Personnel have education, training, and experience to perform assigned tasks."
+ }
+ ]
+ }
+
\ No newline at end of file
diff --git a/packages/ui/src/Atoms/Frameworks/21CFRPart11.tsx b/packages/ui/src/Atoms/Frameworks/21CFRPart11.tsx
new file mode 100644
index 000000000..969446399
--- /dev/null
+++ b/packages/ui/src/Atoms/Frameworks/21CFRPart11.tsx
@@ -0,0 +1,85 @@
+export function TwentyOneCFRPart11(props: { className?: string }) {
+ const { className } = props;
+
+ return (
+
+ );
+}
diff --git a/packages/ui/src/Molecules/FrameworkSelector/FrameworkSelector.tsx b/packages/ui/src/Molecules/FrameworkSelector/FrameworkSelector.tsx
index 2f0c6ac3d..b0cde42ee 100644
--- a/packages/ui/src/Molecules/FrameworkSelector/FrameworkSelector.tsx
+++ b/packages/ui/src/Molecules/FrameworkSelector/FrameworkSelector.tsx
@@ -2,6 +2,7 @@ import { useTranslate } from "@probo/i18n";
import { Button } from "../../Atoms/Button/Button";
import { Dropdown, DropdownItem } from "../../Atoms/Dropdown/Dropdown";
+import { TwentyOneCFRPart11 } from "../../Atoms/Frameworks/21CFRPart11";
import { CCPA } from "../../Atoms/Frameworks/CCPA";
import { DORA } from "../../Atoms/Frameworks/DORA";
import { GDPR } from "../../Atoms/Frameworks/GDPR";
@@ -70,6 +71,12 @@ const availableFrameworks = [
description:
"Information technology, artificial intelligence, management system",
},
+ {
+ id: "21CFR-part11",
+ name: "21 CFR Part 11",
+ logo: ,
+ description: "21 CFR Part 11",
+ },
];
type Framework = (typeof availableFrameworks)[number];