Regulatory Submission Documentation Package
Document Control
Purpose
This document defines the automated regulatory submission documentation system for the CODITECT Biosciences QMS Platform. It specifies the architecture, processes, and technical implementation for assembling, validating, and submitting compliance packages to regulatory authorities and audit firms.
Scope
Covers submission package generation for:
- FDA Computer System Validation (CSV) submissions
- HIPAA Security Risk Assessment documentation
- SOC 2 Type II audit evidence binders
- ISO 13485 quality management system documentation
Approval History
| Version | Date | Approved By | Role | Signature Reference |
|---|---|---|---|---|
| 1.0.0 | 2026-02-16 | [Pending] | Regulatory Affairs Director | DocuSign-REG-004-01 |
| 1.0.0 | 2026-02-16 | [Pending] | Information Security Officer | DocuSign-REG-004-02 |
| 1.0.0 | 2026-02-16 | [Pending] | Quality Assurance Manager | DocuSign-REG-004-03 |
Revision History
| Version | Date | Author | Changes |
|---|---|---|---|
| 1.0.0 | 2026-02-16 | Claude (Opus 4.6) | Initial release - submission architecture |
Distribution List
| Role | Access Level | Distribution Method |
|---|---|---|
| Regulatory Affairs Team | Full | Internal Portal |
| Quality Assurance | Full | Internal Portal |
| Information Security | Full | Internal Portal |
| Engineering Leadership | Read-Only | Internal Portal |
| External Auditors | Package-Only | Secure File Transfer |
| FDA Inspectors | Package-Only | Regulated Portal |
Document References
| Document ID | Title | Version |
|---|---|---|
| CODITECT-BIO-REG-001 | Compliance Framework Architecture | 1.0.0 |
| CODITECT-BIO-REG-002 | FDA Computer System Validation Plan | 1.0.0 |
| CODITECT-BIO-REG-003 | HIPAA Security and Privacy Compliance | 1.0.0 |
| CODITECT-BIO-ARCH-003 | Security Architecture and Controls | 1.0.0 |
| 21 CFR Part 11 | Electronic Records; Electronic Signatures | Current |
| 45 CFR Parts 160, 164 | HIPAA Security and Privacy Rules | Current |
| NIST SP 800-30 Rev. 1 | Guide for Conducting Risk Assessments | 2012 |
| AICPA TSC | Trust Services Criteria | 2017 |
1. Submission Package Architecture
1.1 System Overview
The Regulatory Submission Documentation System automates the collection, validation, assembly, and delivery of compliance evidence packages for multiple regulatory frameworks. The system maintains a unified evidence repository with framework-specific renderers to eliminate duplicate documentation efforts.
1.2 Architecture Components
/**
* Core submission package architecture
*/
interface SubmissionPackageSystem {
evidenceRepository: EvidenceRepository;
packageAssembler: PackageAssembler;
validationEngine: ValidationEngine;
distributionManager: DistributionManager;
auditTrail: AuditTrailService;
}
interface EvidenceRepository {
artifacts: EvidenceArtifact[];
controls: ControlImplementation[];
testResults: ValidationTestResult[];
changeHistory: ChangeRecord[];
riskAssessments: RiskAssessment[];
}
interface PackageAssembler {
frameworks: RegulatoryFramework[];
templates: PackageTemplate[];
renderEngine: DocumentRenderer;
signatureManager: DigitalSignatureService;
}
1.3 Evidence Collection Pipeline
1.4 Package Storage Schema
-- Submission package registry
CREATE TABLE submission_packages (
package_id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
package_type VARCHAR(50) NOT NULL, -- 'FDA_CSV', 'HIPAA_SRA', 'SOC2_TYPE2'
version VARCHAR(20) NOT NULL,
status VARCHAR(20) NOT NULL, -- 'DRAFT', 'REVIEW', 'APPROVED', 'SUBMITTED'
created_by UUID REFERENCES users(user_id),
created_at TIMESTAMPTZ DEFAULT NOW(),
approved_at TIMESTAMPTZ,
submitted_at TIMESTAMPTZ,
package_hash VARCHAR(64) NOT NULL, -- SHA-256 of final PDF
file_path TEXT NOT NULL,
file_size_bytes BIGINT,
metadata JSONB,
CONSTRAINT valid_status CHECK (status IN ('DRAFT', 'REVIEW', 'APPROVED', 'SUBMITTED'))
);
-- Evidence artifacts linked to packages
CREATE TABLE package_evidence (
evidence_id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
package_id UUID REFERENCES submission_packages(package_id) ON DELETE CASCADE,
artifact_type VARCHAR(100) NOT NULL,
artifact_name TEXT NOT NULL,
artifact_path TEXT NOT NULL,
artifact_hash VARCHAR(64) NOT NULL,
collection_timestamp TIMESTAMPTZ NOT NULL,
expiry_date DATE,
metadata JSONB
);
-- Approval workflow
CREATE TABLE package_approvals (
approval_id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
package_id UUID REFERENCES submission_packages(package_id) ON DELETE CASCADE,
approver_id UUID REFERENCES users(user_id),
role VARCHAR(100) NOT NULL,
decision VARCHAR(20) NOT NULL, -- 'APPROVED', 'REJECTED', 'PENDING'
comments TEXT,
approved_at TIMESTAMPTZ DEFAULT NOW(),
digital_signature TEXT NOT NULL,
CONSTRAINT valid_decision CHECK (decision IN ('APPROVED', 'REJECTED', 'PENDING'))
);
-- Distribution tracking
CREATE TABLE package_distributions (
distribution_id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
package_id UUID REFERENCES submission_packages(package_id) ON DELETE CASCADE,
recipient_name TEXT NOT NULL,
recipient_organization TEXT,
distribution_method VARCHAR(50), -- 'SECURE_PORTAL', 'SFTP', 'PHYSICAL_MEDIA'
distributed_at TIMESTAMPTZ DEFAULT NOW(),
distributed_by UUID REFERENCES users(user_id),
acknowledgment_received BOOLEAN DEFAULT FALSE,
acknowledgment_at TIMESTAMPTZ
);
CREATE INDEX idx_packages_type_status ON submission_packages(package_type, status);
CREATE INDEX idx_packages_created ON submission_packages(created_at DESC);
CREATE INDEX idx_evidence_package ON package_evidence(package_id);
CREATE INDEX idx_approvals_package ON package_approvals(package_id);
2. FDA Computer System Validation (CSV) Package
2.1 Package Structure
The FDA CSV submission package follows the GAMP 5 methodology and demonstrates compliance with 21 CFR Part 11 requirements for electronic records and electronic signatures.
2.2 Validation Master Plan Reference
interface FDACSVPackage {
validationMasterPlan: {
documentId: string; // CODITECT-BIO-REG-002
version: string;
systemDescription: string;
riskAssessment: GxPRiskAssessment;
validationStrategy: ValidationStrategy;
};
protocols: {
installationQualification: IQProtocol;
operationalQualification: OQProtocol;
performanceQualification: PQProtocol;
};
traceabilityMatrix: RequirementsTraceabilityMatrix;
validationSummaryReport: ValidationSummaryReport;
deviationReports: DeviationReport[];
changeControlHistory: ChangeControlRecord[];
supportingDocumentation: {
systemArchitecture: Document;
securityControls: Document;
userAccessManagement: Document;
auditTrailSpecification: Document;
disasterRecoveryPlan: Document;
};
}
2.3 IQ/OQ/PQ Protocol Summaries
Installation Qualification (IQ) Summary
interface IQProtocol {
protocolId: string;
version: string;
executionDate: Date;
hardwareVerification: {
serverSpecifications: HardwareSpec[];
networkConfiguration: NetworkTopology;
redundancyValidation: RedundancyTest[];
};
softwareInstallation: {
applicationVersion: string;
dependencies: DependencyManifest;
configurationManagement: ConfigRecord[];
environmentVariables: EnvironmentConfig;
};
securityBaseline: {
firewallRules: FirewallConfig[];
encryptionValidation: EncryptionTest[];
accessControlSetup: AccessControlConfig;
};
acceptanceCriteria: AcceptanceCriterion[];
deviations: Deviation[];
approvals: Approval[];
}
Operational Qualification (OQ) Summary
interface OQProtocol {
protocolId: string;
version: string;
executionDate: Date;
functionalTests: {
userAuthentication: TestCase[];
dataEntry: TestCase[];
calculationVerification: TestCase[];
reportGeneration: TestCase[];
auditTrail: TestCase[];
electronicSignatures: TestCase[];
};
interfaceTests: {
apiValidation: APITestCase[];
dataImportExport: IntegrationTestCase[];
thirdPartyIntegrations: IntegrationTestCase[];
};
securityTests: {
accessControl: SecurityTestCase[];
sessionManagement: SecurityTestCase[];
dataEncryption: SecurityTestCase[];
vulnerabilityScans: VulnerabilityScanResult[];
};
acceptanceCriteria: AcceptanceCriterion[];
deviations: Deviation[];
approvals: Approval[];
}
Performance Qualification (PQ) Summary
interface PQProtocol {
protocolId: string;
version: string;
executionDate: Date;
businessProcessValidation: {
documentControlWorkflow: WorkflowTestCase[];
changeControlProcess: WorkflowTestCase[];
deviationManagement: WorkflowTestCase[];
capaWorkflow: WorkflowTestCase[];
trainingManagement: WorkflowTestCase[];
};
performanceMetrics: {
responseTime: PerformanceTest[];
concurrentUsers: LoadTest[];
dataIntegrity: IntegrityTest[];
backupRestore: DisasterRecoveryTest[];
};
userAcceptanceTesting: {
endUserScenarios: UATScenario[];
realWorldWorkflows: WorkflowValidation[];
userFeedback: UserFeedbackReport[];
};
acceptanceCriteria: AcceptanceCriterion[];
deviations: Deviation[];
approvals: Approval[];
}
2.4 Traceability Matrix
interface RequirementsTraceabilityMatrix {
matrixId: string;
version: string;
generatedAt: Date;
entries: TraceabilityEntry[];
}
interface TraceabilityEntry {
requirementId: string;
requirementDescription: string;
requirementCategory: 'FUNCTIONAL' | 'SECURITY' | 'REGULATORY' | 'PERFORMANCE';
designReferences: {
architectureDocumentId: string;
designSection: string;
implementationDetails: string;
}[];
testReferences: {
testCaseId: string;
testType: 'IQ' | 'OQ' | 'PQ' | 'UAT';
testResult: 'PASS' | 'FAIL' | 'NOT_EXECUTED';
evidencePath: string;
}[];
evidenceArtifacts: {
artifactType: string;
artifactPath: string;
collectionDate: Date;
}[];
coverageStatus: 'COMPLETE' | 'PARTIAL' | 'MISSING';
}
Traceability Matrix SQL Query
-- Generate traceability matrix with coverage analysis
WITH requirement_coverage AS (
SELECT
r.requirement_id,
r.requirement_text,
r.category,
COUNT(DISTINCT t.test_case_id) as test_count,
COUNT(DISTINCT CASE WHEN t.result = 'PASS' THEN t.test_case_id END) as passed_tests,
COUNT(DISTINCT e.evidence_id) as evidence_count
FROM requirements r
LEFT JOIN requirement_test_mapping rtm ON r.requirement_id = rtm.requirement_id
LEFT JOIN test_cases t ON rtm.test_case_id = t.test_case_id
LEFT JOIN requirement_evidence re ON r.requirement_id = re.requirement_id
LEFT JOIN evidence_artifacts e ON re.evidence_id = e.evidence_id
GROUP BY r.requirement_id, r.requirement_text, r.category
)
SELECT
requirement_id,
requirement_text,
category,
test_count,
passed_tests,
evidence_count,
CASE
WHEN test_count > 0 AND passed_tests = test_count AND evidence_count > 0 THEN 'COMPLETE'
WHEN test_count > 0 OR evidence_count > 0 THEN 'PARTIAL'
ELSE 'MISSING'
END as coverage_status,
ROUND(100.0 * passed_tests / NULLIF(test_count, 0), 2) as test_pass_rate
FROM requirement_coverage
ORDER BY coverage_status DESC, category, requirement_id;
2.5 Validation Summary Report Template
interface ValidationSummaryReport {
reportId: string;
systemName: string;
version: string;
reportDate: Date;
executiveSummary: {
purpose: string;
scope: string;
validationApproach: string;
overallConclusion: 'VALIDATED' | 'CONDITIONALLY_VALIDATED' | 'NOT_VALIDATED';
recommendationsForUse: string;
};
systemDescription: {
intendedUse: string;
regulatoryClassification: string; // GAMP Category
criticalityAssessment: CriticalityRating;
affectedRegulations: string[];
};
validationActivities: {
iqSummary: ProtocolExecutionSummary;
oqSummary: ProtocolExecutionSummary;
pqSummary: ProtocolExecutionSummary;
totalTestCases: number;
passedTestCases: number;
failedTestCases: number;
passRate: number;
};
deviationSummary: {
totalDeviations: number;
criticalDeviations: number;
majorDeviations: number;
minorDeviations: number;
allDeviationsClosed: boolean;
outstandingDeviations: Deviation[];
};
riskAssessment: {
residualRisks: RiskItem[];
mitigationStrategies: MitigationStrategy[];
acceptanceRationale: string;
};
recommendations: {
systemApprovedForUse: boolean;
conditions: string[];
periodicReviewSchedule: string;
revalidationTriggers: string[];
};
approvals: {
qualityAssurance: Approval;
regulatoryAffairs: Approval;
systemOwner: Approval;
};
}
interface ProtocolExecutionSummary {
protocolId: string;
executionDate: Date;
totalTests: number;
passedTests: number;
failedTests: number;
deviations: number;
conclusion: string;
}
2.6 Deviation Report Compilation
interface DeviationReport {
deviationId: string;
deviationNumber: string; // DEV-2026-001
reportedDate: Date;
classification: {
severity: 'CRITICAL' | 'MAJOR' | 'MINOR';
category: 'TEST_FAILURE' | 'SPECIFICATION_DEVIATION' | 'PROCEDURE_DEVIATION';
impact: 'GXP' | 'NON_GXP';
};
description: {
expectedResult: string;
actualResult: string;
affectedSystems: string[];
affectedProtocols: string[];
};
investigation: {
rootCauseAnalysis: string;
investigationTeam: string[];
completedDate: Date;
};
correctiveAction: {
actionDescription: string;
implementationDate: Date;
verification: {
method: string;
result: string;
verifiedBy: string;
verifiedDate: Date;
};
};
preventiveAction: {
actionDescription: string;
implementationDate: Date;
effectiveness: string;
};
closure: {
closedBy: string;
closedDate: Date;
qaApproval: Approval;
rationale: string;
};
}
2.7 Change Control History
interface ChangeControlRecord {
changeId: string;
changeNumber: string; // CC-2026-001
requestDate: Date;
classification: {
changeType: 'CORRECTIVE' | 'ENHANCEMENT' | 'PREVENTIVE' | 'REGULATORY';
riskLevel: 'HIGH' | 'MEDIUM' | 'LOW';
validationImpact: 'REVALIDATION_REQUIRED' | 'PARTIAL_REVALIDATION' | 'NO_REVALIDATION';
};
description: {
currentState: string;
proposedChange: string;
justification: string;
affectedComponents: string[];
};
impactAssessment: {
regulatoryImpact: string;
validationImpact: string;
securityImpact: string;
performanceImpact: string;
documentationImpact: string[];
};
approval: {
changeControlBoard: Approval[];
qaApproval: Approval;
regulatoryApproval: Approval;
};
implementation: {
plannedDate: Date;
actualDate: Date;
implementedBy: string;
verificationEvidence: string[];
};
postImplementation: {
effectivenessCheck: string;
lessonsLearned: string;
closureDate: Date;
};
}
3. HIPAA Security Risk Assessment Package
3.1 Risk Assessment Methodology
The CODITECT Biosciences QMS Platform HIPAA Security Risk Assessment follows NIST SP 800-30 Rev. 1 guidelines and addresses all required implementation specifications under the HIPAA Security Rule (45 CFR §164.308, §164.310, §164.312, §164.316).
3.2 Risk Assessment Data Model
interface HIPAARiskAssessment {
assessmentId: string;
version: string;
assessmentDate: Date;
assessmentPeriod: {
startDate: Date;
endDate: Date;
};
methodology: {
framework: 'NIST_SP_800_30' | 'OCTAVE' | 'FAIR';
assessmentType: 'INITIAL' | 'ANNUAL' | 'TRIGGERED';
scope: string;
assumptions: string[];
limitations: string[];
};
assetInventory: AssetInventory;
dataFlowMapping: DataFlowMap;
threatAnalysis: ThreatCatalog;
vulnerabilityAnalysis: VulnerabilityAssessment;
riskScoring: RiskScoringMatrix;
safeguards: SafeguardImplementation[];
residualRisks: ResidualRisk[];
approvals: {
securityOfficial: Approval;
privacyOfficial: Approval;
executiveManagement: Approval;
};
}
3.3 Asset Inventory and Data Flow Mapping
interface AssetInventory {
inventoryDate: Date;
informationAssets: InformationAsset[];
systemAssets: SystemAsset[];
humanAssets: HumanAsset[];
}
interface InformationAsset {
assetId: string;
assetName: string;
assetType: 'EPHI' | 'PHI' | 'PII' | 'PROPRIETARY' | 'PUBLIC';
classification: {
confidentiality: 'HIGH' | 'MODERATE' | 'LOW';
integrity: 'HIGH' | 'MODERATE' | 'LOW';
availability: 'HIGH' | 'MODERATE' | 'LOW';
};
dataElements: {
elementName: string;
dataType: string;
sensitivity: string;
regulatoryRequirement: string[];
}[];
storageLocations: {
system: string;
database: string;
encryptionStatus: boolean;
backupStatus: boolean;
}[];
accessControls: {
authorizedRoles: string[];
accessMethod: string;
mfaRequired: boolean;
};
retentionPeriod: string;
disposalMethod: string;
}
interface DataFlowMap {
flowId: string;
flowName: string;
source: {
system: string;
dataType: string;
sensitivity: string;
};
transit: {
protocol: string;
encryption: boolean;
encryptionStandard: string;
intermediateHops: string[];
};
destination: {
system: string;
purpose: string;
retentionPeriod: string;
};
businessAssociates: {
baName: string;
baAgreementId: string;
dataShared: string[];
}[];
controls: {
authenticationRequired: boolean;
authorizationMethod: string;
loggingEnabled: boolean;
integrityChecks: boolean;
};
}
Asset Inventory SQL Schema
CREATE TABLE information_assets (
asset_id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
asset_name TEXT NOT NULL,
asset_type VARCHAR(50) NOT NULL,
confidentiality_level VARCHAR(20) NOT NULL,
integrity_level VARCHAR(20) NOT NULL,
availability_level VARCHAR(20) NOT NULL,
owner_id UUID REFERENCES users(user_id),
custodian_id UUID REFERENCES users(user_id),
created_at TIMESTAMPTZ DEFAULT NOW(),
last_reviewed TIMESTAMPTZ,
metadata JSONB,
CONSTRAINT valid_asset_type CHECK (asset_type IN ('EPHI', 'PHI', 'PII', 'PROPRIETARY', 'PUBLIC')),
CONSTRAINT valid_cia_levels CHECK (
confidentiality_level IN ('HIGH', 'MODERATE', 'LOW') AND
integrity_level IN ('HIGH', 'MODERATE', 'LOW') AND
availability_level IN ('HIGH', 'MODERATE', 'LOW')
)
);
CREATE TABLE data_flows (
flow_id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
flow_name TEXT NOT NULL,
source_system TEXT NOT NULL,
destination_system TEXT NOT NULL,
data_classification VARCHAR(50) NOT NULL,
transit_encryption BOOLEAN DEFAULT TRUE,
encryption_standard VARCHAR(50),
protocol TEXT,
business_associate_id UUID REFERENCES business_associates(ba_id),
documented_at TIMESTAMPTZ DEFAULT NOW(),
metadata JSONB
);
3.4 Threat and Vulnerability Analysis
interface ThreatCatalog {
catalogVersion: string;
threats: ThreatScenario[];
}
interface ThreatScenario {
threatId: string;
threatName: string;
threatCategory: 'TECHNICAL' | 'HUMAN' | 'ENVIRONMENTAL' | 'ORGANIZATIONAL';
threatSource: {
sourceType: 'ADVERSARIAL' | 'ACCIDENTAL' | 'STRUCTURAL' | 'ENVIRONMENTAL';
capability: 'HIGH' | 'MODERATE' | 'LOW';
intent: 'HIGH' | 'MODERATE' | 'LOW';
targeting: 'HIGH' | 'MODERATE' | 'LOW';
};
threatEvents: {
eventDescription: string;
relevance: 'CONFIRMED' | 'EXPECTED' | 'ANTICIPATED' | 'PREDICTED' | 'NOT_APPLICABLE';
tiering: 'TIER_1' | 'TIER_2' | 'TIER_3'; // Organization, Mission, Information System
}[];
affectedAssets: string[];
likelihood: LikelihoodRating;
vulnerabilitiesExploited: string[];
}
interface VulnerabilityAssessment {
assessmentDate: Date;
vulnerabilities: Vulnerability[];
}
interface Vulnerability {
vulnerabilityId: string;
cveId?: string; // CVE-2024-XXXXX if applicable
description: string;
affectedSystems: string[];
severity: {
cvssScore?: number;
severityRating: 'CRITICAL' | 'HIGH' | 'MEDIUM' | 'LOW' | 'INFO';
};
exploitability: {
attackVector: 'NETWORK' | 'ADJACENT' | 'LOCAL' | 'PHYSICAL';
attackComplexity: 'LOW' | 'HIGH';
privilegesRequired: 'NONE' | 'LOW' | 'HIGH';
userInteraction: 'NONE' | 'REQUIRED';
};
discoveryMethod: 'AUTOMATED_SCAN' | 'MANUAL_REVIEW' | 'PENETRATION_TEST' | 'THIRD_PARTY_REPORT';
remediationStatus: {
status: 'OPEN' | 'IN_PROGRESS' | 'REMEDIATED' | 'ACCEPTED' | 'MITIGATED';
targetDate: Date;
actualDate?: Date;
compensatingControls?: string[];
};
}
3.5 Risk Scoring Matrix
interface RiskScoringMatrix {
methodology: 'LIKELIHOOD_IMPACT' | 'QUALITATIVE' | 'QUANTITATIVE';
likelihoodScale: {
level: 'VERY_HIGH' | 'HIGH' | 'MODERATE' | 'LOW' | 'VERY_LOW';
description: string;
frequency: string;
score: number; // 1-5
}[];
impactScale: {
level: 'VERY_HIGH' | 'HIGH' | 'MODERATE' | 'LOW' | 'VERY_LOW';
description: string;
monetaryRange?: string;
score: number; // 1-5
}[];
riskLevels: {
level: 'CRITICAL' | 'HIGH' | 'MEDIUM' | 'LOW';
scoreRange: [number, number]; // Combined likelihood × impact
responseRequired: string;
escalationRequired: boolean;
}[];
}
interface RiskItem {
riskId: string;
riskDescription: string;
threatId: string;
vulnerabilityId: string;
affectedAssets: string[];
likelihood: {
rating: 'VERY_HIGH' | 'HIGH' | 'MODERATE' | 'LOW' | 'VERY_LOW';
rationale: string;
score: number;
};
impact: {
rating: 'VERY_HIGH' | 'HIGH' | 'MODERATE' | 'LOW' | 'VERY_LOW';
rationale: string;
score: number;
impactCategories: {
confidentiality: number;
integrity: number;
availability: number;
financial: number;
reputational: number;
regulatory: number;
};
};
inherentRisk: {
level: 'CRITICAL' | 'HIGH' | 'MEDIUM' | 'LOW';
score: number; // likelihood × impact
};
controls: string[]; // Applied safeguards
residualRisk: {
level: 'CRITICAL' | 'HIGH' | 'MEDIUM' | 'LOW';
score: number;
acceptanceRationale?: string;
};
riskResponse: {
strategy: 'AVOID' | 'MITIGATE' | 'TRANSFER' | 'ACCEPT';
actionPlan: string;
owner: string;
targetDate: Date;
};
}
Risk Calculation SQL Query
-- Calculate aggregated risk scores by asset and category
WITH risk_calculations AS (
SELECT
r.risk_id,
r.asset_id,
a.asset_name,
a.asset_type,
r.threat_id,
r.vulnerability_id,
r.likelihood_score,
r.impact_score,
(r.likelihood_score * r.impact_score) as inherent_risk_score,
r.residual_risk_score,
r.risk_response_strategy,
CASE
WHEN (r.likelihood_score * r.impact_score) >= 20 THEN 'CRITICAL'
WHEN (r.likelihood_score * r.impact_score) >= 12 THEN 'HIGH'
WHEN (r.likelihood_score * r.impact_score) >= 5 THEN 'MEDIUM'
ELSE 'LOW'
END as inherent_risk_level,
CASE
WHEN r.residual_risk_score >= 20 THEN 'CRITICAL'
WHEN r.residual_risk_score >= 12 THEN 'HIGH'
WHEN r.residual_risk_score >= 5 THEN 'MEDIUM'
ELSE 'LOW'
END as residual_risk_level
FROM risks r
JOIN information_assets a ON r.asset_id = a.asset_id
)
SELECT
asset_type,
COUNT(*) as total_risks,
COUNT(*) FILTER (WHERE inherent_risk_level = 'CRITICAL') as critical_risks,
COUNT(*) FILTER (WHERE inherent_risk_level = 'HIGH') as high_risks,
COUNT(*) FILTER (WHERE inherent_risk_level = 'MEDIUM') as medium_risks,
COUNT(*) FILTER (WHERE inherent_risk_level = 'LOW') as low_risks,
ROUND(AVG(inherent_risk_score), 2) as avg_inherent_risk,
ROUND(AVG(residual_risk_score), 2) as avg_residual_risk,
ROUND(AVG(inherent_risk_score - residual_risk_score), 2) as avg_risk_reduction
FROM risk_calculations
GROUP BY asset_type
ORDER BY avg_inherent_risk DESC;
3.6 Safeguard Implementation Status
interface SafeguardImplementation {
safeguardId: string;
safeguardName: string;
hipaaReference: {
section: string; // e.g., §164.308(a)(1)(ii)(A)
standard: string;
implementationSpec: 'REQUIRED' | 'ADDRESSABLE';
};
controlCategory: 'ADMINISTRATIVE' | 'PHYSICAL' | 'TECHNICAL';
implementationStatus: 'IMPLEMENTED' | 'PARTIALLY_IMPLEMENTED' | 'PLANNED' | 'NOT_APPLICABLE';
implementation: {
description: string;
implementedDate: Date;
owner: string;
evidence: string[];
};
effectiveness: {
lastAssessmentDate: Date;
assessmentMethod: string;
effectivenessRating: 'EFFECTIVE' | 'PARTIALLY_EFFECTIVE' | 'INEFFECTIVE';
findings: string[];
};
mitigatedRisks: string[]; // Risk IDs
testing: {
lastTestDate: Date;
testFrequency: string;
nextTestDate: Date;
testResults: string;
};
}
HIPAA Safeguard Coverage Matrix
| HIPAA Standard | Implementation Spec | Control ID | Implementation Status | Evidence Reference |
|---|---|---|---|---|
| §164.308(a)(1)(i) | Risk Analysis | ADMIN-001 | IMPLEMENTED | HIPAA-RA-2026-Q1 |
| §164.308(a)(1)(ii)(A) | Risk Management | ADMIN-002 | IMPLEMENTED | Risk-Mgmt-Plan-v1.0 |
| §164.308(a)(3)(i) | Workforce Security | ADMIN-003 | IMPLEMENTED | Access-Control-Policy |
| §164.308(a)(4)(i) | Information Access Mgmt | ADMIN-004 | IMPLEMENTED | Role-Matrix-2026 |
| §164.308(a)(5)(i) | Security Awareness | ADMIN-005 | IMPLEMENTED | Training-Records-2026 |
| §164.308(a)(6)(i) | Security Incident Procedures | ADMIN-006 | IMPLEMENTED | Incident-Response-Plan |
| §164.310(a)(1) | Facility Access Controls | PHYS-001 | IMPLEMENTED | AWS-Physical-Security |
| §164.310(d)(1) | Device and Media Controls | PHYS-002 | IMPLEMENTED | Media-Disposal-SOP |
| §164.312(a)(1) | Access Control | TECH-001 | IMPLEMENTED | IAM-Configuration |
| §164.312(b) | Audit Controls | TECH-002 | IMPLEMENTED | CloudTrail-Config |
| §164.312(c)(1) | Integrity | TECH-003 | IMPLEMENTED | Hash-Validation-SOP |
| §164.312(d) | Person or Entity Authentication | TECH-004 | IMPLEMENTED | MFA-Enforcement |
| §164.312(e)(1) | Transmission Security | TECH-005 | IMPLEMENTED | TLS-1.3-Config |
3.7 Business Associate Agreement Registry
interface BusinessAssociateRegistry {
registryVersion: string;
lastUpdated: Date;
businessAssociates: BusinessAssociate[];
}
interface BusinessAssociate {
baId: string;
baName: string;
baType: 'CLOUD_PROVIDER' | 'SOFTWARE_VENDOR' | 'CONSULTING_FIRM' | 'SERVICE_PROVIDER';
agreement: {
baaId: string;
executionDate: Date;
effectiveDate: Date;
expirationDate: Date;
status: 'ACTIVE' | 'EXPIRED' | 'TERMINATED' | 'PENDING_RENEWAL';
signedDocument: string;
};
dataShared: {
dataType: string[];
purpose: string;
minimumNecessary: boolean;
};
services: {
serviceDescription: string;
accessLevel: string;
accessMethod: string;
}[];
securityControls: {
encryptionInTransit: boolean;
encryptionAtRest: boolean;
accessControls: string;
auditLogging: boolean;
incidentNotification: string;
};
compliance: {
soc2Certified: boolean;
hipaaCompliant: boolean;
certifications: string[];
lastAuditDate: Date;
};
riskAssessment: {
riskLevel: 'HIGH' | 'MEDIUM' | 'LOW';
lastAssessmentDate: Date;
findings: string[];
};
}
3.8 Breach Notification Procedures
interface BreachNotificationProcedure {
procedureVersion: string;
breachDefinition: {
qualifyingEvents: string[];
exclusions: string[];
harmThreshold: string;
};
discoveryAndAssessment: {
discoveryTimeframe: string; // "Within 60 days"
assessmentCriteria: {
unauthorizedAcquisition: boolean;
unauthorizedAccess: boolean;
unauthorizedDisclosure: boolean;
};
riskAssessmentFactors: string[];
};
notificationRequirements: {
individualNotification: {
timeframe: string; // "Within 60 days of discovery"
method: 'WRITTEN' | 'EMAIL' | 'SUBSTITUTE';
requiredContent: string[];
};
mediaNotification: {
trigger: string; // ">500 individuals in state/jurisdiction"
timeframe: string;
outlets: string[];
};
hhs Notification: {
timeframe: string; // "Within 60 days" or "Annually"
threshold: number; // 500 individuals
portal: string;
};
};
workflow: BreachNotificationWorkflow;
}
interface BreachNotificationWorkflow {
steps: {
stepNumber: number;
stepName: string;
owner: string;
timeframe: string;
requiredActions: string[];
outputs: string[];
}[];
}
3.9 Security Incident Response Plan Summary
interface SecurityIncidentResponsePlan {
planVersion: string;
lastUpdated: Date;
incidentTypes: {
type: string;
severity: 'CRITICAL' | 'HIGH' | 'MEDIUM' | 'LOW';
examples: string[];
responseTime: string;
}[];
responseTeam: {
role: string;
responsibilities: string[];
contactInfo: string;
backupContact: string;
}[];
escalationMatrix: {
severity: string;
notificationRequired: string[];
timeframe: string;
}[];
responsePhases: {
phase: 'DETECTION' | 'CONTAINMENT' | 'ERADICATION' | 'RECOVERY' | 'LESSONS_LEARNED';
objectives: string[];
actions: string[];
successCriteria: string[];
}[];
documentation: {
incidentLog: string;
evidenceCollection: string;
timelineReconstruction: string;
postIncidentReport: string;
};
}
4. SOC 2 Control Description & Evidence Binder
4.1 Trust Service Criteria Mapping
The SOC 2 Type II audit evidence package maps CODITECT controls to the AICPA Trust Services Criteria (TSC) organized across five categories: Security (CC), Availability (A), Processing Integrity (PI), Confidentiality (C), and Privacy (P).
4.2 Control Framework Data Model
interface SOC2EvidenceBinder {
binderId: string;
auditPeriod: {
startDate: Date;
endDate: Date;
};
auditFirm: {
firmName: string;
auditorName: string;
engagement Id: string;
};
trustServiceCategories: {
commonCriteria: CommonCriteriaControls;
availability: AvailabilityControls;
processingIntegrity: ProcessingIntegrityControls;
confidentiality: ConfidentialityControls;
privacy: PrivacyControls;
};
controlDescriptions: ControlDescription[];
evidenceArtifacts: EvidenceArtifact[];
testingResults: TestingResult[];
exceptions: ControlException[];
complementaryUserEntityControls: CUEC[];
}
4.3 Common Criteria Control Descriptions
interface CommonCriteriaControls {
// CC1: Control Environment
cc1_1_OrganizationalStructure: ControlDescription;
cc1_2_BoardOversight: ControlDescription;
cc1_3_IntegrityAndEthics: ControlDescription;
cc1_4_Commitment ToCompetence: ControlDescription;
cc1_5_AccountabilityStructure: ControlDescription;
// CC2: Communication and Information
cc2_1_InternalCommunication: ControlDescription;
cc2_2_ExternalCommunication: ControlDescription;
cc2_3_QualityInformation: ControlDescription;
// CC3: Risk Assessment
cc3_1_RiskIdentification: ControlDescription;
cc3_2_RiskAnalysis: ControlDescription;
cc3_3_RiskResponse: ControlDescription;
cc3_4_FraudRiskAssessment: ControlDescription;
// CC4: Monitoring Activities
cc4_1_OngoingMonitoring: ControlDescription;
cc4_2_DeficiencyEvaluation: ControlDescription;
// CC5: Control Activities - Logical Access
cc5_1_LogicalAccessControls: ControlDescription;
cc5_2_NewUsers: ControlDescription;
cc5_3_UserChanges: ControlDescription;
cc5_4_UserTerminations: ControlDescription;
// CC6: Control Activities - System Operations
cc6_1_LogicalAndPhysicalSecurity: ControlDescription;
cc6_2_PriorToAuthorization: ControlDescription;
cc6_3_AuthorizedChanges: ControlDescription;
cc6_4_ChangeManagement: ControlDescription;
cc6_5_IncidentResponse: ControlDescription;
cc6_6_VulnerabilityManagement: ControlDescription;
cc6_7_DataBackup: ControlDescription;
cc6_8_BusinessContinuity: ControlDescription;
// CC7: Change Management
cc7_1_ChangeManagementProcess: ControlDescription;
cc7_2_ChangeAuthorization: ControlDescription;
cc7_3_ChangeMonitoring: ControlDescription;
cc7_4_InfrastructureChanges: ControlDescription;
cc7_5_SoftwareChanges: ControlDescription;
// CC8: Risk Mitigation
cc8_1_VendorManagement: ControlDescription;
// CC9: Information Assets
cc9_1_DataClassification: ControlDescription;
cc9_2_DataRetention: ControlDescription;
}
4.4 Control Description Template
interface ControlDescription {
controlId: string; // e.g., "CC6.1"
criterionReference: string;
narrative: {
controlObjective: string;
controlActivity: string;
frequency: 'CONTINUOUS' | 'DAILY' | 'WEEKLY' | 'MONTHLY' | 'QUARTERLY' | 'ANNUALLY' | 'AS_NEEDED';
responsibleParty: string;
controlType: 'PREVENTIVE' | 'DETECTIVE' | 'CORRECTIVE';
automationLevel: 'FULLY_AUTOMATED' | 'PARTIALLY_AUTOMATED' | 'MANUAL';
};
implementation: {
procedures: string[];
tools: string[];
policies: string[];
};
evidenceTypes: {
evidenceType: string;
description: string;
collectionMethod: string;
frequency: string;
}[];
testingApproach: {
testType: 'INQUIRY' | 'OBSERVATION' | 'INSPECTION' | 'REPERFORMANCE';
sampleSize: number;
samplingMethod: string;
testingFrequency: string;
};
complementaryControls: string[];
}
Example: CC6.1 Logical and Physical Security
const cc6_1_LogicalAndPhysicalSecurity: ControlDescription = {
controlId: "CC6.1",
criterionReference: "The entity implements logical access security software, infrastructure, and architectures over protected information assets to protect them from security events to meet the entity's objectives.",
narrative: {
controlObjective: "Protect information assets from unauthorized access through layered security controls including authentication, authorization, network segmentation, and encryption.",
controlActivity: `CODITECT implements multi-layered logical access controls:
1. Identity and Access Management (IAM): AWS IAM with least-privilege RBAC
2. Authentication: Multi-factor authentication (MFA) required for all users
3. Network Security: VPC isolation, security groups, WAF, and CloudFront
4. Encryption: TLS 1.3 for data in transit, AES-256-GCM for data at rest
5. Session Management: 15-minute idle timeout, secure session tokens
6. API Security: OAuth 2.0 + JWT with signature verification
7. Database Access: Citus RLS with row-level tenant isolation
Physical security is managed by AWS infrastructure per SOC 2 Type II certified data centers.`,
frequency: 'CONTINUOUS',
responsibleParty: 'Information Security Officer',
controlType: 'PREVENTIVE',
automationLevel: 'FULLY_AUTOMATED'
},
implementation: {
procedures: [
"Access provisioning follows approval workflow in JIRA",
"Quarterly access reviews by data owners",
"Automated deprovisioning within 24 hours of termination",
"Weekly vulnerability scans and monthly penetration tests",
"Real-time intrusion detection via AWS GuardDuty"
],
tools: [
"AWS IAM and SSO",
"Auth0 for MFA",
"AWS Security Hub",
"AWS GuardDuty",
"AWS WAF",
"Tenable.io vulnerability scanner"
],
policies: [
"Information Security Policy v2.1",
"Access Control Policy v1.5",
"Encryption Standards v1.2"
]
},
evidenceTypes: [
{
evidenceType: "IAM Configuration Screenshots",
description: "AWS IAM roles, policies, and MFA enforcement settings",
collectionMethod: "Automated screenshot via Selenium",
frequency: "Monthly"
},
{
evidenceType: "Access Review Reports",
description: "Quarterly access reviews with owner sign-off",
collectionMethod: "Export from access management system",
frequency: "Quarterly"
},
{
evidenceType: "Vulnerability Scan Reports",
description: "Tenable.io scan results with remediation tracking",
collectionMethod: "API export",
frequency: "Weekly"
},
{
evidenceType: "Penetration Test Reports",
description: "Third-party pentest findings and remediation evidence",
collectionMethod: "Manual upload",
frequency: "Annually"
},
{
evidenceType: "GuardDuty Alerts",
description: "Security event detections and incident response",
collectionMethod: "CloudWatch Logs export",
frequency: "Continuous"
}
],
testingApproach: {
testType: 'INSPECTION',
sampleSize: 25,
samplingMethod: "Random selection of 25 user accounts across all roles",
testingFrequency: "Throughout audit period (quarterly)"
},
complementaryControls: ["CC6.2", "CC6.6", "CC5.1", "CC5.2"]
};
4.5 Evidence Collection Automation
interface EvidenceCollectionPipeline {
pipelineId: string;
pipelineName: string;
schedule: {
frequency: string;
cronExpression: string;
timezone: string;
};
collectors: EvidenceCollector[];
storage: {
repository: string;
retentionPeriod: string;
encryptionEnabled: boolean;
};
validation: {
checksEnabled: boolean;
requiredMetadata: string[];
hashVerification: boolean;
};
notifications: {
successRecipients: string[];
failureRecipients: string[];
escalationThreshold: number;
};
}
interface EvidenceCollector {
collectorId: string;
collectorName: string;
controlIds: string[]; // SOC 2 controls this evidence supports
sourceType: 'AWS_API' | 'DATABASE_QUERY' | 'LOG_EXPORT' | 'SCREENSHOT' | 'MANUAL_UPLOAD';
configuration: {
endpoint?: string;
credentials?: string;
query?: string;
parameters?: Record<string, any>;
};
outputFormat: 'PDF' | 'CSV' | 'JSON' | 'PNG' | 'TXT';
transform: {
redactionRequired: boolean;
redactionRules: string[];
aggregationRules?: string[];
};
metadata: {
evidenceType: string;
collectionMethod: string;
automationLevel: string;
};
}
Evidence Collection Implementation
// Automated IAM configuration evidence collector
const iamConfigCollector: EvidenceCollector = {
collectorId: "SOC2-CC6.1-IAM-001",
collectorName: "AWS IAM Configuration Evidence",
controlIds: ["CC6.1", "CC5.1", "CC5.2"],
sourceType: 'AWS_API',
configuration: {
endpoint: "iam.amazonaws.com",
credentials: "aws-soc2-evidence-role",
parameters: {
services: ["IAM", "SSO", "Organizations"],
resources: ["Users", "Groups", "Roles", "Policies", "MFADevices"]
}
},
outputFormat: 'JSON',
transform: {
redactionRequired: true,
redactionRules: [
"REDACT: AccessKeyId",
"REDACT: SecretAccessKey",
"MASK: Email (preserve domain)"
]
},
metadata: {
evidenceType: "Configuration Artifact",
collectionMethod: "AWS API boto3.client('iam')",
automationLevel: "Fully Automated"
}
};
// Python implementation
async function collectIAMEvidence(): Promise<EvidenceArtifact> {
const iam = new AWS.IAM();
const evidence = {
collectionTimestamp: new Date(),
collectorId: "SOC2-CC6.1-IAM-001",
data: {
users: await iam.listUsers().promise(),
mfaDevices: await iam.listVirtualMFADevices().promise(),
roles: await iam.listRoles().promise(),
policies: await iam.listPolicies({ Scope: 'Local' }).promise(),
accountPasswordPolicy: await iam.getAccountPasswordPolicy().promise()
}
};
// Apply redaction
const redacted = redactSensitiveData(evidence, iamConfigCollector.transform.redactionRules);
// Generate hash
const hash = crypto.createHash('sha256').update(JSON.stringify(redacted)).digest('hex');
// Store evidence
const artifact: EvidenceArtifact = {
artifactId: `${evidence.collectorId}-${Date.now()}`,
controlIds: iamConfigCollector.controlIds,
artifactType: "Configuration Snapshot",
collectionDate: evidence.collectionTimestamp,
format: 'JSON',
filePath: `s3://coditect-soc2-evidence/iam/${hash}.json`,
hash: hash,
metadata: {
collector: iamConfigCollector.collectorName,
recordCount: Object.keys(redacted.data).length,
redactionApplied: true
}
};
await uploadToS3(artifact.filePath, redacted);
await recordArtifact(artifact);
return artifact;
}
4.6 Continuous Monitoring Dashboard Integration
interface ContinuousMonitoringDashboard {
dashboardId: string;
controlHealth: {
controlId: string;
status: 'EFFECTIVE' | 'DEFICIENT' | 'NOT_TESTED' | 'EXCEPTION';
lastTestDate: Date;
nextTestDate: Date;
trendDirection: 'IMPROVING' | 'STABLE' | 'DEGRADING';
}[];
evidenceMetrics: {
totalArtifacts: number;
collectedThisMonth: number;
collectionSuccessRate: number;
averageCollectionTime: number;
storageUsed: number;
};
exceptionSummary: {
openExceptions: number;
criticalExceptions: number;
averageRemediationTime: number;
overdueExceptions: number;
};
auditReadiness: {
controlsCovered: number;
totalControls: number;
coveragePercentage: number;
evidenceGaps: string[];
};
alerts: MonitoringAlert[];
}
interface MonitoringAlert {
alertId: string;
severity: 'CRITICAL' | 'HIGH' | 'MEDIUM' | 'LOW';
category: 'CONTROL_FAILURE' | 'EVIDENCE_GAP' | 'EXCEPTION_OVERDUE' | 'CONFIGURATION_DRIFT';
message: string;
affectedControls: string[];
detectedAt: Date;
acknowledgedBy?: string;
resolvedAt?: Date;
}
4.7 Exception Tracking and Remediation
interface ControlException {
exceptionId: string;
exceptionNumber: string; // SOC2-EXC-2026-001
controlId: string;
criterionReference: string;
discovery: {
discoveredDate: Date;
discoveredBy: string;
discoveryMethod: 'TESTING' | 'MONITORING' | 'SELF_IDENTIFIED' | 'AUDITOR_NOTED';
};
description: {
nature: string;
scope: string;
frequency: 'ISOLATED' | 'RECURRING';
affectedPeriod: {
startDate: Date;
endDate: Date;
};
};
impact: {
severity: 'CRITICAL' | 'SIGNIFICANT' | 'MINOR';
trustServiceCriteriaImpact: string[];
businessImpact: string;
compensatingControls: string[];
};
rootCause: {
analysis: string;
contributingFactors: string[];
controlDeficiency: 'DESIGN' | 'OPERATING_EFFECTIVENESS';
};
remediation: {
plan: string;
owner: string;
targetDate: Date;
completedDate?: Date;
verification: {
method: string;
verifiedBy: string;
verifiedDate?: Date;
testResults: string;
};
};
management Response: {
response: string;
approvedBy: string;
approvedDate: Date;
};
}
4.8 Complementary User Entity Controls (CUECs)
interface ComplementaryUserEntityControl {
cuecId: string;
cuecNumber: string; // CUEC-001
description: string;
relatedControls: string[]; // SOC 2 control IDs
userResponsibility: {
action: string;
frequency: string;
owner: string;
};
rationale: string;
exampleImplementation: string;
verificationMethod: string;
}
Example CUECs
const cuecs: ComplementaryUserEntityControl[] = [
{
cuecId: "CUEC-001",
cuecNumber: "CUEC-001",
description: "User entities are responsible for immediately reporting suspected security incidents or unauthorized access to CODITECT support.",
relatedControls: ["CC6.5", "CC7.3"],
userResponsibility: {
action: "Report security incidents via support portal or emergency hotline",
frequency: "Immediately upon discovery",
owner: "Customer Security Team"
},
rationale: "Timely incident reporting enables CODITECT to contain and remediate security events before significant impact.",
exampleImplementation: "Customer maintains internal incident response procedures with CODITECT escalation contacts.",
verificationMethod: "Review customer incident response plan during onboarding"
},
{
cuecId: "CUEC-002",
cuecNumber: "CUEC-002",
description: "User entities are responsible for managing user access rights within their tenant, including provisioning, modification, and deprovisioning of users.",
relatedControls: ["CC5.2", "CC5.3", "CC5.4"],
userResponsibility: {
action: "Maintain accurate user access based on role and need-to-know",
frequency: "Ongoing, with quarterly access reviews",
owner: "Customer System Administrator"
},
rationale: "CODITECT provides role-based access controls, but customers determine appropriate access levels for their users.",
exampleImplementation: "Customer performs quarterly user access reviews and removes terminated users within 24 hours.",
verificationMethod: "Audit customer access review documentation"
},
{
cuecId: "CUEC-003",
cuecNumber: "CUEC-003",
description: "User entities are responsible for configuring and enforcing multi-factor authentication (MFA) for their users.",
relatedControls: ["CC6.1", "CC5.1"],
userResponsibility: {
action: "Enable and enforce MFA for all user accounts",
frequency: "Continuous enforcement",
owner: "Customer IT Security"
},
rationale: "While CODITECT supports MFA, customer tenant administrators control MFA enforcement policies.",
exampleImplementation: "Customer enables 'Require MFA' setting in tenant security configuration.",
verificationMethod: "Inspect customer tenant MFA enforcement settings"
}
];
5. Cross-Framework Evidence Mapping
5.1 Shared Controls Across FDA/HIPAA/SOC 2
interface CrossFrameworkControlMapping {
mappingId: string;
mappingVersion: string;
unifiedControl: {
controlId: string; // Internal unified ID
controlName: string;
controlObjective: string;
implementationDescription: string;
};
frameworkMappings: {
framework: 'FDA_CSV' | 'HIPAA' | 'SOC2' | 'ISO27001';
frameworkControlId: string;
frameworkReference: string;
mappingConfidence: 'DIRECT' | 'PARTIAL' | 'RELATED';
}[];
evidenceArtifacts: {
artifactId: string;
artifactType: string;
usableForFrameworks: string[];
}[];
}
Control Mapping Example: Audit Trail
const auditTrailMapping: CrossFrameworkControlMapping = {
mappingId: "UNIFIED-CTRL-008",
mappingVersion: "1.0",
unifiedControl: {
controlId: "CODITECT-AUDIT-001",
controlName: "Comprehensive Audit Trail",
controlObjective: "Maintain tamper-evident audit logs of all system activities, user actions, and data modifications to support compliance, forensics, and accountability.",
implementationDescription: `
CODITECT implements immutable audit logging across all system layers:
1. Application Layer: Django audit log middleware captures all API requests, data changes, and user actions
2. Database Layer: PostgreSQL/Citus triggers log all DML operations with before/after values
3. Infrastructure Layer: AWS CloudTrail logs all AWS API calls and resource changes
4. Authentication Layer: Auth0 logs all authentication events, MFA challenges, and session lifecycle
Audit logs include: timestamp (UTC), user identity, action type, affected resources, IP address, user agent, result (success/failure), and hash chain for tamper detection.
Logs are retained for 7 years, encrypted at rest (AES-256), and replicated to immutable S3 Glacier storage.
`
},
frameworkMappings: [
{
framework: 'FDA_CSV',
frameworkControlId: "21-CFR-11.10(e)",
frameworkReference: "Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions",
mappingConfidence: 'DIRECT'
},
{
framework: 'HIPAA',
frameworkControlId: "§164.312(b)",
frameworkReference: "Audit Controls - Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information",
mappingConfidence: 'DIRECT'
},
{
framework: 'SOC2',
frameworkControlId: "CC6.1 / CC7.3",
frameworkReference: "Logical access security and change management monitoring",
mappingConfidence: 'DIRECT'
},
{
framework: 'ISO27001',
frameworkControlId: "A.12.4.1",
frameworkReference: "Event logging - Event logs recording user activities, exceptions, faults and information security events shall be produced, kept and regularly reviewed",
mappingConfidence: 'DIRECT'
}
],
evidenceArtifacts: [
{
artifactId: "AUDIT-CONF-001",
artifactType: "Audit Configuration Screenshots",
usableForFrameworks: ['FDA_CSV', 'HIPAA', 'SOC2', 'ISO27001']
},
{
artifactId: "AUDIT-SAMPLE-001",
artifactType: "Audit Log Sample Export (Redacted)",
usableForFrameworks: ['FDA_CSV', 'HIPAA', 'SOC2', 'ISO27001']
},
{
artifactId: "AUDIT-RETENTION-001",
artifactType: "S3 Glacier Retention Policy",
usableForFrameworks: ['FDA_CSV', 'HIPAA', 'SOC2']
},
{
artifactId: "AUDIT-INTEGRITY-001",
artifactType: "Hash Chain Validation Report",
usableForFrameworks: ['FDA_CSV', 'SOC2']
}
]
};
5.2 Evidence Reuse Matrix
-- Evidence reuse analysis across frameworks
CREATE TABLE framework_evidence_mapping (
mapping_id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
evidence_artifact_id UUID REFERENCES evidence_artifacts(artifact_id),
framework VARCHAR(50) NOT NULL,
framework_control_id TEXT NOT NULL,
mapping_type VARCHAR(20) NOT NULL, -- 'DIRECT', 'PARTIAL', 'SUPPLEMENTAL'
customization_required BOOLEAN DEFAULT FALSE,
customization_notes TEXT,
created_at TIMESTAMPTZ DEFAULT NOW(),
CONSTRAINT valid_framework CHECK (framework IN ('FDA_CSV', 'HIPAA', 'SOC2', 'ISO27001', 'ISO13485'))
);
-- Query to identify evidence artifacts supporting multiple frameworks
SELECT
ea.artifact_id,
ea.artifact_name,
ea.artifact_type,
COUNT(DISTINCT fem.framework) as framework_count,
STRING_AGG(DISTINCT fem.framework, ', ' ORDER BY fem.framework) as frameworks,
STRING_AGG(DISTINCT fem.framework_control_id, ', ') as control_ids
FROM evidence_artifacts ea
JOIN framework_evidence_mapping fem ON ea.artifact_id = fem.evidence_artifact_id
GROUP BY ea.artifact_id, ea.artifact_name, ea.artifact_type
HAVING COUNT(DISTINCT fem.framework) > 1
ORDER BY framework_count DESC, ea.artifact_name;
5.3 Unified Audit Trail Integration
The unified audit trail serves as foundational evidence across all regulatory frameworks. Implementation details in CODITECT-BIO-ARCH-003 Section 6.4.
interface UnifiedAuditLog {
logId: string;
timestamp: Date;
actor: {
userId: string;
userName: string;
role: string;
tenantId: string;
};
action: {
actionType: string; // CREATE, READ, UPDATE, DELETE, EXECUTE, LOGIN, LOGOUT
actionCategory: 'DATA_ACCESS' | 'SYSTEM_CONFIG' | 'USER_MGMT' | 'AUTH' | 'WORKFLOW';
description: string;
};
target: {
resourceType: string;
resourceId: string;
resourceName: string;
dataClassification?: string;
};
context: {
ipAddress: string;
userAgent: string;
sessionId: string;
requestId: string;
};
result: {
status: 'SUCCESS' | 'FAILURE' | 'PARTIAL';
errorCode?: string;
errorMessage?: string;
};
changes?: {
fieldName: string;
oldValue: string;
newValue: string;
}[];
compliance: {
fdaRelevant: boolean;
hipaaRelevant: boolean;
soc2Relevant: boolean;
};
integrity: {
previousLogHash: string;
currentLogHash: string; // SHA-256 of log entry + previousLogHash
};
}
6. Automated Package Assembly
6.1 Package Generation Pipeline
interface PackageGenerationPipeline {
pipelineId: string;
packageType: 'FDA_CSV' | 'HIPAA_SRA' | 'SOC2_TYPE2';
stages: PipelineStage[];
configuration: {
templatePath: string;
outputFormat: 'PDF_A_2B' | 'PDF_A_3B';
digitalSignatureRequired: boolean;
approvalWorkflowRequired: boolean;
};
}
interface PipelineStage {
stageNumber: number;
stageName: string;
tasks: {
taskName: string;
taskType: 'EVIDENCE_COLLECTION' | 'DOCUMENT_GENERATION' | 'VALIDATION' | 'APPROVAL' | 'SIGNATURE' | 'DISTRIBUTION';
executor: string; // Service or role
timeout: number;
retryPolicy: {
maxRetries: number;
backoffStrategy: 'EXPONENTIAL' | 'LINEAR';
};
}[];
successCriteria: string[];
failureHandling: 'ABORT' | 'CONTINUE' | 'MANUAL_REVIEW';
}
FDA CSV Package Generation Pipeline
const fdaCSVPipeline: PackageGenerationPipeline = {
pipelineId: "PIPELINE-FDA-CSV-001",
packageType: 'FDA_CSV',
stages: [
{
stageNumber: 1,
stageName: "Evidence Collection",
tasks: [
{
taskName: "Collect IQ Protocol Evidence",
taskType: 'EVIDENCE_COLLECTION',
executor: "EvidenceCollectorService",
timeout: 60000,
retryPolicy: { maxRetries: 3, backoffStrategy: 'EXPONENTIAL' }
},
{
taskName: "Collect OQ Protocol Evidence",
taskType: 'EVIDENCE_COLLECTION',
executor: "EvidenceCollectorService",
timeout: 60000,
retryPolicy: { maxRetries: 3, backoffStrategy: 'EXPONENTIAL' }
},
{
taskName: "Collect PQ Protocol Evidence",
taskType: 'EVIDENCE_COLLECTION',
executor: "EvidenceCollectorService",
timeout: 60000,
retryPolicy: { maxRetries: 3, backoffStrategy: 'EXPONENTIAL' }
},
{
taskName: "Generate Traceability Matrix",
taskType: 'DOCUMENT_GENERATION',
executor: "TraceabilityMatrixGenerator",
timeout: 120000,
retryPolicy: { maxRetries: 2, backoffStrategy: 'LINEAR' }
}
],
successCriteria: [
"All protocol evidence collected",
"Traceability matrix generated with 100% requirement coverage"
],
failureHandling: 'ABORT'
},
{
stageNumber: 2,
stageName: "Package Assembly",
tasks: [
{
taskName: "Compile Validation Summary Report",
taskType: 'DOCUMENT_GENERATION',
executor: "ValidationReportGenerator",
timeout: 180000,
retryPolicy: { maxRetries: 2, backoffStrategy: 'LINEAR' }
},
{
taskName: "Attach Supporting Documentation",
taskType: 'DOCUMENT_GENERATION',
executor: "DocumentAssembler",
timeout: 120000,
retryPolicy: { maxRetries: 3, backoffStrategy: 'EXPONENTIAL' }
},
{
taskName: "Generate Table of Contents with Hyperlinks",
taskType: 'DOCUMENT_GENERATION',
executor: "TOCGenerator",
timeout: 60000,
retryPolicy: { maxRetries: 2, backoffStrategy: 'LINEAR' }
}
],
successCriteria: [
"All sections included",
"TOC hyperlinks functional",
"Document passes PDF/A-2b validation"
],
failureHandling: 'MANUAL_REVIEW'
},
{
stageNumber: 3,
stageName: "Validation",
tasks: [
{
taskName: "Validate Completeness",
taskType: 'VALIDATION',
executor: "CompletenessValidator",
timeout: 60000,
retryPolicy: { maxRetries: 1, backoffStrategy: 'LINEAR' }
},
{
taskName: "Validate PDF/A-2b Compliance",
taskType: 'VALIDATION',
executor: "PDFAValidator",
timeout: 30000,
retryPolicy: { maxRetries: 1, backoffStrategy: 'LINEAR' }
}
],
successCriteria: [
"No missing sections",
"PDF/A-2b compliant"
],
failureHandling: 'ABORT'
},
{
stageNumber: 4,
stageName: "Approval",
tasks: [
{
taskName: "QA Review",
taskType: 'APPROVAL',
executor: "ApprovalWorkflowService",
timeout: 86400000, // 24 hours
retryPolicy: { maxRetries: 0, backoffStrategy: 'LINEAR' }
},
{
taskName: "Regulatory Affairs Approval",
taskType: 'APPROVAL',
executor: "ApprovalWorkflowService",
timeout: 86400000,
retryPolicy: { maxRetries: 0, backoffStrategy: 'LINEAR' }
}
],
successCriteria: [
"All approvals obtained",
"Digital signatures applied"
],
failureHandling: 'MANUAL_REVIEW'
},
{
stageNumber: 5,
stageName: "Digital Signature",
tasks: [
{
taskName: "Apply Digital Signatures",
taskType: 'SIGNATURE',
executor: "DigitalSignatureService",
timeout: 60000,
retryPolicy: { maxRetries: 2, backoffStrategy: 'EXPONENTIAL' }
},
{
taskName: "Generate Package Hash",
taskType: 'SIGNATURE',
executor: "HashGeneratorService",
timeout: 30000,
retryPolicy: { maxRetries: 2, backoffStrategy: 'LINEAR' }
}
],
successCriteria: [
"Digital signatures valid",
"SHA-256 hash recorded"
],
failureHandling: 'ABORT'
},
{
stageNumber: 6,
stageName: "Distribution",
tasks: [
{
taskName: "Upload to Secure Repository",
taskType: 'DISTRIBUTION',
executor: "DistributionService",
timeout: 120000,
retryPolicy: { maxRetries: 3, backoffStrategy: 'EXPONENTIAL' }
},
{
taskName: "Notify Stakeholders",
taskType: 'DISTRIBUTION',
executor: "NotificationService",
timeout: 30000,
retryPolicy: { maxRetries: 3, backoffStrategy: 'EXPONENTIAL' }
}
],
successCriteria: [
"Package uploaded successfully",
"Notifications sent"
],
failureHandling: 'MANUAL_REVIEW'
}
],
configuration: {
templatePath: "templates/fda-csv-package-template.docx",
outputFormat: 'PDF_A_2B',
digitalSignatureRequired: true,
approvalWorkflowRequired: true
}
};
6.2 PDF/A-2b Generation with Digital Signatures
import { PDFDocument, rgb } from 'pdf-lib';
import { SignPDF } from 'node-signpdf';
import fs from 'fs';
interface PDFGenerationConfig {
templatePath: string;
outputPath: string;
metadata: {
title: string;
author: string;
subject: string;
keywords: string[];
creator: string;
producer: string;
};
pdfACompliance: 'PDF_A_2B' | 'PDF_A_3B';
digitalSignature: {
certificatePath: string;
privateKeyPath: string;
reason: string;
location: string;
contactInfo: string;
};
}
async function generateRegulatoryPackagePDF(
config: PDFGenerationConfig,
content: SubmissionPackage
): Promise<string> {
// Step 1: Generate base PDF from template
const pdfDoc = await PDFDocument.load(fs.readFileSync(config.templatePath));
// Step 2: Set PDF metadata
pdfDoc.setTitle(config.metadata.title);
pdfDoc.setAuthor(config.metadata.author);
pdfDoc.setSubject(config.metadata.subject);
pdfDoc.setKeywords(config.metadata.keywords);
pdfDoc.setCreator(config.metadata.creator);
pdfDoc.setProducer(config.metadata.producer);
pdfDoc.setCreationDate(new Date());
pdfDoc.setModificationDate(new Date());
// Step 3: Add content sections
await addTableOfContents(pdfDoc, content.tableOfContents);
await addDocumentControl(pdfDoc, content.documentControl);
await addValidationSummary(pdfDoc, content.validationSummary);
await addProtocolSummaries(pdfDoc, content.protocols);
await addTraceabilityMatrix(pdfDoc, content.traceabilityMatrix);
await addSupportingDocuments(pdfDoc, content.supportingDocuments);
// Step 4: Add hyperlinked table of contents
await addHyperlinks(pdfDoc, content.tableOfContents);
// Step 5: Ensure PDF/A-2b compliance
await ensurePDFACompliance(pdfDoc, config.pdfACompliance);
// Step 6: Save unsigned PDF
const unsignedPdfBytes = await pdfDoc.save();
const unsignedPath = config.outputPath.replace('.pdf', '-unsigned.pdf');
fs.writeFileSync(unsignedPath, unsignedPdfBytes);
// Step 7: Apply digital signature
const signedPdfBytes = await applyDigitalSignature(
unsignedPdfBytes,
config.digitalSignature
);
fs.writeFileSync(config.outputPath, signedPdfBytes);
// Step 8: Generate SHA-256 hash
const hash = crypto.createHash('sha256').update(signedPdfBytes).digest('hex');
// Step 9: Record package metadata
await recordPackageMetadata({
packagePath: config.outputPath,
packageHash: hash,
generatedAt: new Date(),
signatureInfo: config.digitalSignature
});
return config.outputPath;
}
async function applyDigitalSignature(
pdfBytes: Uint8Array,
signatureConfig: PDFGenerationConfig['digitalSignature']
): Promise<Buffer> {
const certificate = fs.readFileSync(signatureConfig.certificatePath);
const privateKey = fs.readFileSync(signatureConfig.privateKeyPath);
const signer = new SignPDF();
const signedPdf = signer.sign(Buffer.from(pdfBytes), {
certificate: certificate,
key: privateKey,
reason: signatureConfig.reason,
location: signatureConfig.location,
contact: signatureConfig.contactInfo,
appearance: {
page: -1, // Last page
rect: [50, 50, 200, 100],
text: `Digitally signed by ${signatureConfig.contactInfo}\nDate: ${new Date().toISOString()}\nReason: ${signatureConfig.reason}`
}
});
return signedPdf;
}
6.3 Hyperlinked Table of Contents
interface TableOfContents {
sections: TOCSection[];
}
interface TOCSection {
sectionNumber: string;
title: string;
pageNumber: number;
subsections?: TOCSection[];
}
async function addTableOfContents(
pdfDoc: PDFDocument,
toc: TableOfContents
): Promise<void> {
const page = pdfDoc.addPage([612, 792]); // Letter size
const { width, height } = page.getSize();
const font = await pdfDoc.embedFont('Helvetica-Bold');
const regularFont = await pdfDoc.embedFont('Helvetica');
let yPosition = height - 72; // 1 inch from top
page.drawText('Table of Contents', {
x: 72,
y: yPosition,
size: 18,
font: font,
color: rgb(0, 0, 0)
});
yPosition -= 36;
for (const section of toc.sections) {
await renderTOCSection(page, section, yPosition, 0, regularFont, pdfDoc);
yPosition -= 20;
if (section.subsections) {
for (const subsection of section.subsections) {
yPosition = await renderTOCSection(page, subsection, yPosition, 20, regularFont, pdfDoc);
yPosition -= 15;
}
}
}
}
async function renderTOCSection(
page: PDFPage,
section: TOCSection,
yPosition: number,
indentation: number,
font: PDFFont,
pdfDoc: PDFDocument
): Promise<number> {
const text = `${section.sectionNumber} ${section.title}`;
const pageText = `${section.pageNumber}`;
// Draw section text
page.drawText(text, {
x: 72 + indentation,
y: yPosition,
size: 12,
font: font,
color: rgb(0, 0, 0.8)
});
// Draw page number
page.drawText(pageText, {
x: 540,
y: yPosition,
size: 12,
font: font,
color: rgb(0, 0, 0.8)
});
// Add hyperlink to section
const linkAnnotation = pdfDoc.context.obj({
Type: 'Annot',
Subtype: 'Link',
Rect: [72 + indentation, yPosition - 2, 540, yPosition + 12],
Border: [0, 0, 0],
Dest: `page_${section.pageNumber}`,
C: [0, 0, 0.8]
});
page.node.set(PDFName.of('Annots'), pdfDoc.context.obj([linkAnnotation]));
return yPosition;
}
6.4 Evidence Attachment Automation
interface EvidenceAttachment {
evidenceId: string;
evidenceName: string;
evidenceType: string;
filePath: string;
attachmentMethod: 'EMBED' | 'HYPERLINK' | 'APPENDIX';
}
async function attachEvidence(
pdfDoc: PDFDocument,
evidence: EvidenceAttachment[]
): Promise<void> {
for (const item of evidence) {
switch (item.attachmentMethod) {
case 'EMBED':
await embedFile(pdfDoc, item);
break;
case 'HYPERLINK':
await addHyperlink(pdfDoc, item);
break;
case 'APPENDIX':
await appendDocument(pdfDoc, item);
break;
}
}
}
async function embedFile(
pdfDoc: PDFDocument,
evidence: EvidenceAttachment
): Promise<void> {
const fileBytes = fs.readFileSync(evidence.filePath);
await pdfDoc.attach(fileBytes, evidence.evidenceName, {
mimeType: getMimeType(evidence.evidenceType),
description: `Evidence: ${evidence.evidenceName}`,
creationDate: new Date(),
modificationDate: new Date()
});
}
6.5 Version Control and Change Tracking
CREATE TABLE package_versions (
version_id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
package_id UUID REFERENCES submission_packages(package_id) ON DELETE CASCADE,
version_number VARCHAR(20) NOT NULL, -- Semantic versioning
change_description TEXT NOT NULL,
changed_sections TEXT[], -- Array of section identifiers
created_by UUID REFERENCES users(user_id),
created_at TIMESTAMPTZ DEFAULT NOW(),
previous_version_id UUID REFERENCES package_versions(version_id),
diff_file_path TEXT, -- Path to diff document
approval_required BOOLEAN DEFAULT TRUE,
approved_by UUID REFERENCES users(user_id),
approved_at TIMESTAMPTZ
);
CREATE INDEX idx_package_versions_package ON package_versions(package_id);
CREATE INDEX idx_package_versions_created ON package_versions(created_at DESC);
7. Submission Workflow
7.1 Pre-Submission Review Checklist
interface PreSubmissionChecklist {
checklistId: string;
packageId: string;
packageType: string;
completenessChecks: {
checkId: string;
requirement: string;
status: 'PASS' | 'FAIL' | 'NOT_APPLICABLE';
verifiedBy: string;
verifiedDate: Date;
notes?: string;
}[];
qualityChecks: {
checkId: string;
criterion: string;
status: 'PASS' | 'FAIL';
verifiedBy: string;
verifiedDate: Date;
notes?: string;
}[];
overallStatus: 'READY_FOR_SUBMISSION' | 'REQUIRES_REMEDIATION';
sign Off: {
reviewer: string;
role: string;
signedAt: Date;
digitalSignature: string;
}[];
}
FDA CSV Pre-Submission Checklist
const fdaCSVChecklist: PreSubmissionChecklist = {
checklistId: "CHECKLIST-FDA-CSV-2026-001",
packageId: "PKG-FDA-CSV-2026-001",
packageType: "FDA_CSV",
completenessChecks: [
{
checkId: "COMP-001",
requirement: "Validation Master Plan included and approved",
status: 'PASS',
verifiedBy: "qa-manager@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "COMP-002",
requirement: "IQ Protocol executed with all test cases passed or deviations closed",
status: 'PASS',
verifiedBy: "qa-manager@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "COMP-003",
requirement: "OQ Protocol executed with all test cases passed or deviations closed",
status: 'PASS',
verifiedBy: "qa-manager@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "COMP-004",
requirement: "PQ Protocol executed with all test cases passed or deviations closed",
status: 'PASS',
verifiedBy: "qa-manager@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "COMP-005",
requirement: "Requirements Traceability Matrix shows 100% coverage",
status: 'PASS',
verifiedBy: "qa-engineer@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "COMP-006",
requirement: "All deviations documented and closed",
status: 'PASS',
verifiedBy: "qa-manager@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "COMP-007",
requirement: "Validation Summary Report approved by QA and Regulatory Affairs",
status: 'PASS',
verifiedBy: "regulatory-affairs@coditect.com",
verifiedDate: new Date("2026-02-16")
}
],
qualityChecks: [
{
checkId: "QUAL-001",
criterion: "All signatures present and authenticated",
status: 'PASS',
verifiedBy: "qa-manager@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "QUAL-002",
criterion: "Dates are consistent and chronologically correct",
status: 'PASS',
verifiedBy: "qa-engineer@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "QUAL-003",
criterion: "Document references are accurate and current",
status: 'PASS',
verifiedBy: "documentation-specialist@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "QUAL-004",
criterion: "PDF/A-2b compliance verified",
status: 'PASS',
verifiedBy: "qa-engineer@coditect.com",
verifiedDate: new Date("2026-02-16")
},
{
checkId: "QUAL-005",
criterion: "Table of Contents hyperlinks functional",
status: 'PASS',
verifiedBy: "qa-engineer@coditect.com",
verifiedDate: new Date("2026-02-16")
}
],
overallStatus: 'READY_FOR_SUBMISSION',
signOff: [
{
reviewer: "QA Manager",
role: "Quality Assurance",
signedAt: new Date("2026-02-16T14:30:00Z"),
digitalSignature: "SHA256:a3f9b2c..."
},
{
reviewer: "Regulatory Affairs Director",
role: "Regulatory Compliance",
signedAt: new Date("2026-02-16T15:45:00Z"),
digitalSignature: "SHA256:b4e8c1d..."
}
]
};
7.2 Reviewer Assignment and Approval Chain
interface ApprovalWorkflow {
workflowId: string;
packageId: string;
approvalChain: ApprovalStep[];
currentStep: number;
status: 'IN_PROGRESS' | 'APPROVED' | 'REJECTED' | 'ON_HOLD';
}
interface ApprovalStep {
stepNumber: number;
role: string;
assignedTo: string[];
approvalType: 'SEQUENTIAL' | 'PARALLEL' | 'ANY_ONE';
dueDate: Date;
decisions: {
reviewerId: string;
decision: 'APPROVED' | 'REJECTED' | 'CHANGES_REQUESTED';
comments: string;
decidedAt: Date;
digitalSignature: string;
}[];
status: 'PENDING' | 'APPROVED' | 'REJECTED' | 'CHANGES_REQUESTED';
}
7.3 Post-Submission Tracking and Follow-Up
interface SubmissionTracking {
trackingId: string;
packageId: string;
submission: {
submittedTo: string; // Regulatory body or audit firm
submittedBy: string;
submittedAt: Date;
submissionMethod: string;
confirmationNumber?: string;
};
timeline: {
event: string;
eventDate: Date;
notes: string;
}[];
communications: {
communicationId: string;
direction: 'INBOUND' | 'OUTBOUND';
from: string;
to: string;
subject: string;
date: Date;
attachments: string[];
summary: string;
}[];
requests: {
requestId: string;
requestType: 'CLARIFICATION' | 'ADDITIONAL_EVIDENCE' | 'CORRECTION';
requestedAt: Date;
requestDetails: string;
responseRequired By: Date;
responseProvided: boolean;
responseDate?: Date;
responseSummary?: string;
}[];
outcome: {
finalDecision?: 'APPROVED' | 'APPROVED_WITH_CONDITIONS' | 'REJECTED';
decisionDate?: Date;
conditions?: string[];
nextSteps?: string[];
};
}
7.4 Auditor Response Management
interface AuditorResponseManagement {
responseId: string;
packageId: string;
auditorRequest: {
requestId: string;
requestDate: Date;
requestor: string;
requestDetails: string;
samplesRequested: string[];
documentRequests: string[];
};
responsePreparation: {
assignedTo: string;
dueDate: Date;
status: 'IN_PROGRESS' | 'READY_FOR_REVIEW' | 'SUBMITTED';
evidenceGathered: {
evidenceId: string;
evidenceType: string;
collectedFrom: string;
collectedAt: Date;
}[];
narrative: string;
};
review: {
reviewedBy: string[];
reviewedAt: Date;
approvedForSubmission: boolean;
comments: string;
};
submission: {
submittedBy: string;
submittedAt: Date;
submissionMethod: string;
acknowledgmentReceived: boolean;
};
}
8. API Endpoints
8.1 Package Generation API
/**
* POST /api/v1/regulatory/packages/generate
*
* Generate a regulatory submission package
*/
interface GeneratePackageRequest {
packageType: 'FDA_CSV' | 'HIPAA_SRA' | 'SOC2_TYPE2';
version: string;
auditPeriod?: {
startDate: string;
endDate: string;
};
includeEvidence: boolean;
metadata: Record<string, any>;
}
interface GeneratePackageResponse {
packageId: string;
status: 'GENERATING' | 'COMPLETED' | 'FAILED';
jobId: string;
estimatedCompletionTime: string;
message: string;
}
// Usage
const response = await fetch('/api/v1/regulatory/packages/generate', {
method: 'POST',
headers: {
'Authorization': `Bearer ${accessToken}`,
'Content-Type': 'application/json'
},
body: JSON.stringify({
packageType: 'FDA_CSV',
version: '1.0.0',
includeEvidence: true,
metadata: {
systemName: 'CODITECT Biosciences QMS Platform',
validationDate: '2026-02-16'
}
})
});
const data: GeneratePackageResponse = await response.json();
8.2 Package Status API
/**
* GET /api/v1/regulatory/packages/{packageId}/status
*/
interface PackageStatusResponse {
packageId: string;
packageType: string;
version: string;
status: string;
createdAt: string;
completedAt?: string;
approvedAt?: string;
submittedAt?: string;
progress: {
stage: string;
percentComplete: number;
currentTask: string;
estimatedTimeRemaining: number;
};
approvals: {
role: string;
status: 'PENDING' | 'APPROVED' | 'REJECTED';
approvedBy?: string;
approvedAt?: string;
}[];
downloadUrl?: string;
packageHash?: string;
}
8.3 Evidence Management API
/**
* GET /api/v1/regulatory/evidence
*/
interface ListEvidenceRequest {
frameworkType?: string;
controlId?: string;
collectionDateStart?: string;
collectionDateEnd?: string;
page?: number;
pageSize?: number;
}
interface ListEvidenceResponse {
evidence: {
evidenceId: string;
evidenceName: string;
evidenceType: string;
frameworks: string[];
controlIds: string[];
collectionDate: string;
expiryDate?: string;
downloadUrl: string;
}[];
pagination: {
page: number;
pageSize: number;
totalRecords: number;
totalPages: number;
};
}
/**
* POST /api/v1/regulatory/evidence/collect
*/
interface CollectEvidenceRequest {
collectorId: string;
parameters?: Record<string, any>;
}
interface CollectEvidenceResponse {
jobId: string;
status: 'QUEUED' | 'IN_PROGRESS' | 'COMPLETED' | 'FAILED';
message: string;
}
9. Testing Strategy
9.1 Package Integrity Testing
describe('Regulatory Package Generation', () => {
test('FDA CSV package includes all required sections', async () => {
const packageId = await generatePackage('FDA_CSV');
const packageContents = await getPackageContents(packageId);
expect(packageContents).toHaveProperty('validationMasterPlan');
expect(packageContents).toHaveProperty('iqProtocol');
expect(packageContents).toHaveProperty('oqProtocol');
expect(packageContents).toHaveProperty('pqProtocol');
expect(packageContents).toHaveProperty('traceabilityMatrix');
expect(packageContents).toHaveProperty('validationSummaryReport');
expect(packageContents).toHaveProperty('deviationReports');
expect(packageContents).toHaveProperty('changeControlHistory');
});
test('Traceability matrix shows 100% requirement coverage', async () => {
const matrix = await generateTraceabilityMatrix();
const coverage = matrix.entries.filter(e => e.coverageStatus === 'COMPLETE');
const totalRequirements = matrix.entries.length;
const coveragePercentage = (coverage.length / totalRequirements) * 100;
expect(coveragePercentage).toBe(100);
});
test('Generated PDF is valid PDF/A-2b', async () => {
const packageId = await generatePackage('FDA_CSV');
const pdfPath = await downloadPackage(packageId);
const validation = await validatePDFA(pdfPath, 'PDF_A_2B');
expect(validation.valid).toBe(true);
expect(validation.errors).toHaveLength(0);
});
test('Digital signatures are valid and verifiable', async () => {
const packageId = await generatePackage('FDA_CSV');
const pdfPath = await downloadPackage(packageId);
const signatures = await extractSignatures(pdfPath);
expect(signatures.length).toBeGreaterThan(0);
for (const signature of signatures) {
const verification = await verifySignature(signature);
expect(verification.valid).toBe(true);
expect(verification.certificateChainValid).toBe(true);
expect(verification.timestampValid).toBe(true);
}
});
test('Package hash matches stored hash', async () => {
const packageId = await generatePackage('FDA_CSV');
const pdfBytes = await downloadPackageBytes(packageId);
const computedHash = crypto.createHash('sha256').update(pdfBytes).digest('hex');
const storedHash = await getStoredHash(packageId);
expect(computedHash).toBe(storedHash);
});
});
9.2 Evidence Collection Testing
describe('Evidence Collection Automation', () => {
test('IAM configuration evidence collected successfully', async () => {
const jobId = await triggerEvidenceCollection('SOC2-CC6.1-IAM-001');
const result = await waitForCompletion(jobId);
expect(result.status).toBe('COMPLETED');
expect(result.artifactId).toBeDefined();
const artifact = await getEvidence(result.artifactId);
expect(artifact.data).toHaveProperty('users');
expect(artifact.data).toHaveProperty('mfaDevices');
expect(artifact.data).toHaveProperty('roles');
expect(artifact.data).toHaveProperty('policies');
});
test('Redaction rules applied correctly', async () => {
const jobId = await triggerEvidenceCollection('SOC2-CC6.1-IAM-001');
const result = await waitForCompletion(jobId);
const artifact = await getEvidence(result.artifactId);
// Verify no sensitive data in output
const stringified = JSON.stringify(artifact.data);
expect(stringified).not.toContain('AccessKeyId');
expect(stringified).not.toContain('SecretAccessKey');
expect(stringified).not.toMatch(/AKIA[0-9A-Z]{16}/); // AWS access key pattern
});
test('Evidence hash verification', async () => {
const jobId = await triggerEvidenceCollection('SOC2-CC6.1-IAM-001');
const result = await waitForCompletion(jobId);
const artifact = await getEvidence(result.artifactId);
const computedHash = crypto.createHash('sha256')
.update(JSON.stringify(artifact.data))
.digest('hex');
expect(computedHash).toBe(artifact.hash);
});
});
9.3 Cross-Framework Mapping Testing
describe('Cross-Framework Evidence Mapping', () => {
test('Audit trail evidence maps to all frameworks', async () => {
const mapping = await getCrossFrameworkMapping('UNIFIED-CTRL-008');
expect(mapping.frameworkMappings).toContainEqual(
expect.objectContaining({ framework: 'FDA_CSV' })
);
expect(mapping.frameworkMappings).toContainEqual(
expect.objectContaining({ framework: 'HIPAA' })
);
expect(mapping.frameworkMappings).toContainEqual(
expect.objectContaining({ framework: 'SOC2' })
);
// Verify evidence artifacts are reusable
for (const artifact of mapping.evidenceArtifacts) {
expect(artifact.usableForFrameworks.length).toBeGreaterThanOrEqual(2);
}
});
test('No duplicate evidence collection for shared controls', async () => {
const fdaPackage = await generatePackage('FDA_CSV');
const soc2Package = await generatePackage('SOC2_TYPE2');
const fdaEvidence = await getPackageEvidence(fdaPackage);
const soc2Evidence = await getPackageEvidence(soc2Package);
const fdaAuditEvidence = fdaEvidence.find(e => e.artifactType === 'Audit Configuration');
const soc2AuditEvidence = soc2Evidence.find(e => e.artifactType === 'Audit Configuration');
// Should reference same artifact
expect(fdaAuditEvidence.artifactId).toBe(soc2AuditEvidence.artifactId);
});
});
10. Implementation Roadmap
10.1 Phase 1: Foundation (Weeks 1-2)
- Database schema implementation (submission_packages, package_evidence, etc.)
- Evidence repository infrastructure
- Basic package assembly pipeline
- PDF generation without signatures
10.2 Phase 2: Evidence Automation (Weeks 3-4)
- Automated evidence collectors (IAM, CloudTrail, Database, Application logs)
- Redaction and transformation rules
- Evidence validation and integrity checks
- Continuous monitoring dashboard
10.3 Phase 3: Framework-Specific Packages (Weeks 5-7)
- FDA CSV package template and generator
- HIPAA SRA package template and generator
- SOC 2 Type II evidence binder template and generator
- Cross-framework mapping implementation
10.4 Phase 4: Workflow and Signatures (Week 8)
- Approval workflow engine
- Digital signature integration (DocuSign or Adobe Sign)
- PDF/A-2b compliance validation
- Hyperlinked table of contents generation
10.5 Phase 5: Testing and Validation (Week 9)
- Comprehensive test suite
- Package integrity validation
- End-to-end workflow testing
- Security and compliance review
10.6 Phase 6: Deployment and Documentation (Week 10)
- Production deployment
- User training materials
- Operational runbooks
- Continuous improvement monitoring
Conclusion
This Regulatory Submission Documentation Package specification provides a comprehensive, automated framework for generating FDA CSV, HIPAA Security Risk Assessment, and SOC 2 Type II audit packages. The system leverages cross-framework evidence mapping to eliminate duplication, maintains package integrity through cryptographic hashing and digital signatures, and ensures audit readiness through continuous evidence collection.
Key Features:
- Automated evidence collection with 95%+ automation rate
- Cross-framework evidence reuse reducing duplication by 60%+
- PDF/A-2b compliance with digital signatures for long-term archival
- Continuous monitoring and exception tracking
- End-to-end audit trail from evidence collection to submission
Compliance Coverage:
- FDA 21 CFR Part 11 Computer System Validation
- HIPAA Security Rule (45 CFR §164.308, §164.310, §164.312, §164.316)
- SOC 2 Trust Service Criteria (CC1-CC9, A1, PI1, C1)
- ISO 13485 Quality Management Systems
Document Status: Active Next Review Date: 2027-02-16 Change Control: All changes require approval from Regulatory Affairs Director and Quality Assurance Manager
Generated by: CODITECT Compliance Framework Specialist Task ID: D.5.4 Date: 2026-02-16