Bryan Frimin
@@ -7,64 +7,144 @@
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},
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"controls": [
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{
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"id": "P11-001",
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"id": "11.10(a)",
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"name": "System Validation",
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"description": "Systems are validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records."
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"description": "Validate electronic record systems to ensure accuracy, reliability, consistent intended performance, and the ability to detect invalid or altered records."
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},
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{
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"id": "P11-002",
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"id": "11.10(b)",
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"name": "Record Copies",
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"description": "Generate accurate and complete copies of electronic records in both human-readable and electronic form suitable for FDA inspection, review, and copying."
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},
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{
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"id": "11.10(c)",
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"name": "Record Protection and Retention",
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"description": "Protect electronic records to ensure accurate and ready retrieval throughout the required retention period."
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},
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{
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"id": "11.10(d)",
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"name": "Access Control",
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"description": "Limit system access to authorized individuals."
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},
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{
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"id": "11.10(e)",
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"name": "Audit Trails",
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"description": "Secure, computer-generated, time-stamped audit trails independently record operator entries and actions."
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"description": "Use secure, computer-generated, time-stamped audit trails to record creation, modification, or deletion of electronic records; ensure prior information is not obscured and audit trails are retained with the records."
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},
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{
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"id": "P11-003",
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"name": "Record Retention",
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"description": "Electronic records are protected to enable accurate and ready retrieval throughout the records retention period."
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"id": "11.10(f)",
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"name": "Operational Controls",
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"description": "Implement system checks to enforce permitted sequencing of steps and events."
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},
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{
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"id": "P11-004",
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"name": "Access Controls",
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"description": "System access is limited to authorized individuals with unique user IDs."
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"id": "11.10(g)",
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"name": "Authority Controls",
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"description": "Ensure only authorized individuals can use the system, sign records, access devices, or alter records."
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},
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{
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"id": "P11-005",
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"name": "Electronic Signatures",
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"description": "Electronic signatures are unique to an individual and verifiable."
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"id": "11.10(h)",
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"name": "Device Controls",
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"description": "Verify the validity of data input sources and operational instructions where applicable."
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},
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{
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"id": "P11-006",
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"name": "Signature Linking",
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"description": "Electronic signatures are permanently linked to their respective electronic records."
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"id": "11.10(i)",
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"name": "Personnel Competency",
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"description": "Ensure individuals who develop, maintain, or use electronic record or signature systems are trained, qualified, and competent."
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},
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{
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"id": "P11-007",
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"name": "Signature Integrity",
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"description": "Electronic signatures cannot be excised, copied, or transferred to falsify an electronic record."
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"id": "11.10(j)",
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"name": "Accountability Policies",
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"description": "Establish and enforce written policies holding individuals accountable for actions taken under electronic signatures."
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},
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{
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"id": "P11-008",
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"name": "Signature Binding Enforcement",
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"description": "System enforces technical and procedural controls to maintain binding between record content and signature."
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"id": "11.10(k)(1)",
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"name": "Documentation Access Controls",
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"description": "Control the distribution, access, and use of system documentation."
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},
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{
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"id": "P11-009",
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"name": "Operational Checks",
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"description": "Operational system checks enforce permitted sequencing of steps and events."
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"id": "11.10(k)(2)",
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"name": "Documentation Change Control",
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"description": "Maintain an audit trail of time-sequenced development and changes to system documentation."
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},
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{
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"id": "P11-010",
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"name": "Authority Checks",
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"description": "Authority checks ensure only authorized individuals can use the system or sign records."
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"id": "11.30",
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"name": "Open System Protections",
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"description": "Apply additional safeguards (e.g., encryption, digital signatures) to protect the authenticity, integrity, and confidentiality of records in open systems."
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},
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{
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"id": "P11-011",
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"name": "Device Checks",
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"description": "Device checks determine the validity of the source of data input."
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"id": "11.50(a)",
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"name": "Signature Manifestation",
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"description": "Ensure signed electronic records display the signer's name, date/time of signing, and meaning of the signature."
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},
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{
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"id": "P11-012",
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"name": "Training",
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"description": "Personnel have education, training, and experience to perform assigned tasks."
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"id": "11.50(b)",
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"name": "Signature Record Integrity",
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"description": "Subject signature information to the same controls as electronic records and include it in human-readable outputs."
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},
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{
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"id": "11.70",
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"name": "Signature-to-Record Linking",
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"description": "Securely link electronic signatures to their respective records to prevent excision, copying, or transfer."
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},
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{
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"id": "11.100(a)",
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"name": "Signature Uniqueness",
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"description": "Ensure each electronic signature is unique to one individual and is not reused or reassigned."
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},
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{
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"id": "11.100(b)",
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"name": "Identity Verification",
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"description": "Verify an individual's identity before assigning or authorizing an electronic signature."
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},
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{
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"id": "11.100(c)",
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"name": "Signature Legal Certification",
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"description": "Certify to the FDA that electronic signatures are intended to be legally binding equivalents of handwritten signatures."
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},
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{
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"id": "11.200(a)(1)",
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"name": "Multi-Factor Signature Components",
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"description": "Require at least two distinct identification components (e.g., ID and password) for non-biometric electronic signatures."
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},
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{
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"id": "11.200(a)(2)",
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"name": "Signature Ownership Control",
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"description": "Ensure electronic signatures are used only by their genuine owners."
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},
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{
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"id": "11.200(a)(3)",
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"name": "Signature Misuse Prevention",
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"description": "Implement controls requiring collaboration of two or more individuals for unauthorized signature use."
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},
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{
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"id": "11.200(b)",
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"name": "Biometric Signature Protection",
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"description": "Ensure biometric electronic signatures cannot be used by anyone other than their genuine owners."
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},
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{
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"id": "11.300(a)",
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"name": "Credential Uniqueness",
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"description": "Maintain the uniqueness of identification code and password combinations."
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},
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{
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"id": "11.300(b)",
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"name": "Credential Lifecycle Management",
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"description": "Periodically check, recall, or revise identification codes and passwords."
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},
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{
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"id": "11.300(c)",
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"name": "Credential Loss Management",
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"description": "Deauthorize lost, stolen, or compromised authentication devices and issue replacements securely."
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},
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{
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"id": "11.300(d)",
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"name": "Unauthorized Access Detection",
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"description": "Implement safeguards to detect and immediately report unauthorized use of credentials."
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},
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{
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"id": "11.300(e)",
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"name": "Authentication Device Integrity Testing",
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"description": "Perform initial and periodic testing of authentication devices to detect unauthorized alteration."
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}
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]
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}
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