project-document-management-docs-000-10-compliance-framework
title: Compliance Framework Specification type: reference version: 1.0.0 created: '2025-12-27' updated: '2025-12-27' status: deprecated tags:
- ai-ml
- authentication
- deployment
- security
- testing
- api
- architecture
- automation summary: 'Compliance Framework Specification Document ID: 000.10 Version: 1.0.0 Status: Draft Last Updated: December 19, 2025 Owner: CODITECT Document Management Team --- Executive Summary This specification defines the compliance framework for the CODITECT...' moe_confidence: 1.000 moe_classified: 2025-12-29
Compliance Framework Specification
Document ID: 000.10 Version: 1.0.0 Status: Draft Last Updated: December 19, 2025 Owner: CODITECT Document Management Team
1. Executive Summary
This specification defines the compliance framework for the CODITECT Document Management System, enabling deployment in regulated industries including healthcare (HIPAA), financial services (SOX), life sciences (FDA 21 CFR Part 11), and organizations handling EU personal data (GDPR).
1.1 Compliance Certifications Target
| Regulation | Industry | Target Date | Priority |
|---|---|---|---|
| HIPAA | Healthcare | Q2 2026 | P0 |
| SOX | Financial Services | Q2 2026 | P0 |
| GDPR | All (EU Data) | Q1 2026 | P0 |
| FDA 21 CFR Part 11 | Life Sciences | Q3 2026 | P1 |
| FedRAMP | Government | Q4 2026 | P2 |
| ISO 27001 | All | Q2 2026 | P1 |
| SOC 2 Type II | All | Q2 2026 | P1 |
2. Multi-Factor Authentication (MFA)
2.1 Requirements
The system SHALL support multi-factor authentication for all user access.
class MFAConfiguration:
"""MFA configuration for compliance requirements."""
class MFAMethod(Enum):
TOTP = "totp" # Time-based OTP (Google Auth, Authy)
SMS = "sms" # SMS verification (not recommended for HIPAA)
EMAIL = "email" # Email verification
PUSH = "push" # Push notification
HARDWARE_KEY = "hardware_key" # FIDO2/WebAuthn (YubiKey)
BIOMETRIC = "biometric" # Fingerprint, Face ID
# Minimum methods required per compliance level
COMPLIANCE_REQUIREMENTS = {
"hipaa": {"min_factors": 2, "allowed": [TOTP, HARDWARE_KEY, BIOMETRIC]},
"sox": {"min_factors": 2, "allowed": [TOTP, HARDWARE_KEY, PUSH]},
"fda_part11": {"min_factors": 2, "allowed": [TOTP, HARDWARE_KEY, BIOMETRIC]},
"gdpr": {"min_factors": 1, "allowed": [TOTP, SMS, EMAIL, PUSH]},
"standard": {"min_factors": 1, "allowed": "all"}
}
2.2 MFA Enrollment Flow
1. User completes primary authentication (username/password)
2. System checks MFA requirement for user's compliance level
3. If MFA not enrolled:
a. Present MFA enrollment wizard
b. Guide through primary method setup (TOTP recommended)
c. Require backup method for recovery
d. Store encrypted recovery codes
4. If MFA enrolled:
a. Present MFA challenge
b. Validate response within time window (30 seconds for TOTP)
c. Log successful/failed attempts
5. Grant access token with MFA claim
2.3 API Specification
POST /api/v1/auth/mfa/enroll
Content-Type: application/json
{
"method": "totp",
"device_name": "iPhone 15 Pro"
}
Response:
{
"secret": "BASE32ENCODEDSECRET",
"qr_code_url": "data:image/png;base64,...",
"backup_codes": ["XXXX-XXXX", "YYYY-YYYY", ...]
}
POST /api/v1/auth/mfa/verify
Content-Type: application/json
{
"method": "totp",
"code": "123456"
}
Response:
{
"verified": true,
"access_token": "eyJ...",
"mfa_verified": true
}
3. Configurable Retention Policies
3.1 Requirements
The system SHALL support configurable document retention periods to meet regulatory requirements.
| Regulation | Minimum Retention | Maximum Retention | Notes |
|---|---|---|---|
| HIPAA | 6 years | State-specific (up to 10 years) | From last service date |
| SOX | 5 years (records) | 7 years (audit docs) | From creation |
| GDPR | Purpose-limited | Must delete when no longer needed | Right to erasure |
| FDA 21 CFR Part 11 | Duration of clinical trial + 2 years | Indefinite for approved products | GxP requirements |
| Legal Hold | Indefinite | Until hold released | Overrides all policies |
3.2 Retention Policy Schema
class RetentionPolicy:
"""Document retention policy definition."""
id: UUID
name: str # "HIPAA Medical Records"
description: str
# Retention period
retention_period: timedelta # e.g., timedelta(days=365*7)
retention_unit: Literal["days", "months", "years"]
retention_trigger: Literal[
"creation_date", # From document creation
"last_modified", # From last modification
"last_accessed", # From last access
"custom_date_field", # From metadata field
"workflow_completion" # From workflow end
]
# Actions
expiration_action: Literal[
"archive", # Move to archive storage
"delete", # Permanent deletion
"review", # Queue for manual review
"extend" # Auto-extend for active docs
]
# Scope
applies_to_document_types: list[str] # ["contract", "medical_record"]
applies_to_classifications: list[str] # ["confidential", "phi"]
# Compliance mapping
compliance_frameworks: list[str] # ["hipaa", "sox"]
# Legal hold override
legal_hold_exempt: bool = False # If True, legal holds don't apply
# Notifications
notify_before_expiration: list[int] # Days before: [90, 30, 7]
notify_recipients: list[str] # User IDs or roles
3.3 Retention API Endpoints
# Create retention policy
POST /api/v1/compliance/retention-policies
{
"name": "HIPAA PHI Records",
"retention_period": 2555,
"retention_unit": "days",
"retention_trigger": "last_modified",
"expiration_action": "archive",
"applies_to_classifications": ["phi"],
"compliance_frameworks": ["hipaa"],
"notify_before_expiration": [90, 30, 7]
}
# Apply policy to document
POST /api/v1/documents/{document_id}/retention
{
"policy_id": "uuid-of-policy"
}
# Check retention status
GET /api/v1/documents/{document_id}/retention
Response:
{
"policy": "HIPAA PHI Records",
"expires_at": "2032-12-19T00:00:00Z",
"days_remaining": 2555,
"legal_hold": false,
"action_on_expiry": "archive"
}
4. HIPAA Compliance Module
4.1 Protected Health Information (PHI) Handling
class PHIClassification:
"""PHI detection and classification."""
# PHI identifiers per HIPAA Safe Harbor
PHI_IDENTIFIERS = [
"name",
"geographic_data", # Smaller than state
"dates", # Birth, admission, discharge, death
"phone_numbers",
"fax_numbers",
"email_addresses",
"ssn",
"medical_record_numbers",
"health_plan_numbers",
"account_numbers",
"certificate_numbers",
"vehicle_identifiers",
"device_identifiers",
"web_urls",
"ip_addresses",
"biometric_identifiers",
"photos",
"unique_identifiers"
]
def classify_document(self, content: str) -> PHIResult:
"""Scan document for PHI and return classification."""
detected = []
for identifier in self.PHI_IDENTIFIERS:
if self._detect_identifier(content, identifier):
detected.append(identifier)
return PHIResult(
contains_phi=len(detected) > 0,
detected_identifiers=detected,
recommended_classification="phi" if detected else "general",
requires_encryption=len(detected) > 0,
requires_access_logging=len(detected) > 0
)
4.2 Business Associate Agreement (BAA) Workflow
class BAAWorkflow:
"""Business Associate Agreement management."""
class BAAStatus(Enum):
PENDING = "pending"
SENT = "sent"
SIGNED = "signed"
EXPIRED = "expired"
TERMINATED = "terminated"
class BusinessAssociate:
id: UUID
organization_name: str
contact_email: str
services_provided: list[str]
phi_access_level: Literal["view", "process", "store"]
baa_status: BAAStatus
baa_document_id: Optional[UUID]
signed_date: Optional[datetime]
expiration_date: Optional[datetime]
annual_review_date: Optional[datetime]
4.3 HIPAA Audit Trail Requirements
class HIPAAAuditEvent:
"""HIPAA-compliant audit trail entry."""
# Required fields
event_id: UUID
timestamp: datetime # UTC with milliseconds
user_id: UUID
user_email: str
user_role: str
# Action details
action: Literal[
"view", "download", "print", "export",
"create", "modify", "delete",
"share", "permission_change",
"access_attempt", "access_denied"
]
# Resource
document_id: UUID
document_name: str
document_classification: str
contains_phi: bool
# Context
ip_address: str
user_agent: str
session_id: UUID
# Immutability
event_hash: str # SHA-256 of event data
previous_hash: str # Chain to previous event
# Retention
retention_required_until: datetime # 6 years minimum
5. SOX Compliance Module
5.1 Internal Controls Over Financial Reporting (ICFR)
class ICFRControl:
"""SOX Section 404 internal control definition."""
id: UUID
control_name: str
control_description: str
control_type: Literal["preventive", "detective", "corrective"]
# Ownership
control_owner: UUID # User responsible
process_owner: UUID # Business process owner
# Testing
test_frequency: Literal["daily", "weekly", "monthly", "quarterly", "annual"]
last_test_date: Optional[datetime]
last_test_result: Literal["effective", "ineffective", "not_tested"]
# Evidence
evidence_documents: list[UUID] # Supporting documentation
# Risk assessment
risk_rating: Literal["high", "medium", "low"]
financial_statement_assertions: list[str] # Existence, completeness, etc.
5.2 SOX Document Classification
class SOXDocumentType(Enum):
"""SOX-regulated document types with retention requirements."""
FINANCIAL_RECORD = ("financial_record", 5) # 5-year retention
AUDIT_WORKPAPER = ("audit_workpaper", 7) # 7-year retention
BOARD_MINUTES = ("board_minutes", 7)
INTERNAL_CONTROL = ("internal_control", 7)
EMAIL_FINANCIAL = ("email_financial", 5)
CONTRACT_FINANCIAL = ("contract_financial", 7)
TAX_RECORD = ("tax_record", 7)
5.3 Management Attestation Workflow
class SOXAttestation:
"""Section 302/404 attestation workflow."""
class AttestationType(Enum):
SECTION_302 = "section_302" # CEO/CFO certification
SECTION_404 = "section_404" # Internal control assessment
id: UUID
attestation_type: AttestationType
fiscal_period: str # "Q4 2025", "FY 2025"
# Signatories
ceo_user_id: UUID
cfo_user_id: UUID
ceo_signed: bool
cfo_signed: bool
ceo_signed_at: Optional[datetime]
cfo_signed_at: Optional[datetime]
# Supporting evidence
control_assessments: list[UUID] # ICFR control test results
deficiency_reports: list[UUID] # Any identified issues
remediation_plans: list[UUID] # Plans to fix issues
# Status
status: Literal["draft", "pending_ceo", "pending_cfo", "complete", "filed"]
filing_deadline: datetime
filed_at: Optional[datetime]
6. GDPR Compliance Module
6.1 Data Subject Rights
class DataSubjectRequest:
"""GDPR data subject rights management."""
class RequestType(Enum):
ACCESS = "access" # Right to access (Art. 15)
RECTIFICATION = "rectification" # Right to rectify (Art. 16)
ERASURE = "erasure" # Right to erasure/RTBF (Art. 17)
PORTABILITY = "portability" # Right to data portability (Art. 20)
RESTRICTION = "restriction" # Right to restrict processing (Art. 18)
OBJECTION = "objection" # Right to object (Art. 21)
id: UUID
request_type: RequestType
data_subject_email: str
data_subject_verified: bool
# Timeline (GDPR requires response within 30 days)
received_at: datetime
due_date: datetime # received_at + 30 days
completed_at: Optional[datetime]
# Processing
status: Literal["received", "verifying", "processing", "complete", "denied"]
denial_reason: Optional[str] # If denied, reason required
# Affected documents
documents_identified: list[UUID]
documents_processed: list[UUID]
# Evidence
processing_log: list[dict] # Detailed action log
response_document_id: Optional[UUID]
6.2 Right to Erasure (RTBF) Workflow
class ErasureWorkflow:
"""GDPR Article 17 - Right to Erasure implementation."""
async def process_erasure_request(
self,
request: DataSubjectRequest
) -> ErasureResult:
"""Process a right to erasure request."""
# 1. Identify all documents containing subject's data
documents = await self.search_documents_by_subject(
request.data_subject_email
)
# 2. Check for retention exemptions
exempt_documents = []
erasable_documents = []
for doc in documents:
exemption = self.check_retention_exemption(doc)
if exemption:
exempt_documents.append({
"document_id": doc.id,
"exemption_reason": exemption.reason,
"legal_basis": exemption.legal_basis
})
else:
erasable_documents.append(doc.id)
# 3. Check for legal holds
legal_holds = await self.check_legal_holds(erasable_documents)
# 4. Execute erasure for non-exempt documents
erasure_results = []
for doc_id in erasable_documents:
if doc_id not in legal_holds:
result = await self.erase_document(doc_id)
erasure_results.append(result)
# 5. Generate compliance report
return ErasureResult(
request_id=request.id,
documents_erased=len(erasure_results),
documents_exempt=len(exempt_documents),
documents_held=len(legal_holds),
exemption_details=exempt_documents,
completed_at=datetime.utcnow()
)
ERASURE_EXEMPTIONS = [
"legal_obligation", # Required by law
"public_interest", # Public health, archiving
"legal_claims", # Establishment/defense of claims
"freedom_of_expression", # Journalism, research
]
6.3 Data Portability Export
class DataPortabilityExport:
"""GDPR Article 20 - Data Portability implementation."""
EXPORT_FORMATS = ["json", "csv", "xml"]
async def generate_export(
self,
data_subject_email: str,
format: str = "json"
) -> ExportResult:
"""Generate portable data export for data subject."""
# Collect all data for subject
data = {
"export_date": datetime.utcnow().isoformat(),
"data_subject": data_subject_email,
"format_version": "1.0",
"documents": [],
"metadata": [],
"activity_log": []
}
# Include documents
documents = await self.get_documents_by_subject(data_subject_email)
for doc in documents:
data["documents"].append({
"id": str(doc.id),
"name": doc.name,
"created_at": doc.created_at.isoformat(),
"content": doc.content, # Or download URL
"metadata": doc.metadata
})
# Include activity history
activities = await self.get_activity_by_subject(data_subject_email)
data["activity_log"] = activities
# Generate export file
if format == "json":
export_file = json.dumps(data, indent=2)
elif format == "csv":
export_file = self.convert_to_csv(data)
return ExportResult(
download_url=self.store_export(export_file),
expires_at=datetime.utcnow() + timedelta(days=7),
format=format,
size_bytes=len(export_file)
)
7. FDA 21 CFR Part 11 Compliance Module
7.1 Electronic Signature Requirements
class Part11ElectronicSignature:
"""FDA 21 CFR Part 11 compliant electronic signature."""
# Signature components (minimum 2 required)
user_id: UUID
identification_code: str # User ID/username
password_verified: bool # Password verification
biometric_verified: Optional[bool] # Optional biometric
# Signature meaning
signature_meaning: Literal[
"authored", # Created the document
"reviewed", # Reviewed content
"approved", # Approved for release
"verified", # Verified accuracy
"rejected" # Rejected/disapproved
]
# Timestamp
signed_at: datetime # Server timestamp (UTC)
timezone: str # User's timezone for display
# Binding
document_id: UUID
document_version: str
document_hash: str # SHA-256 of document at signing
# Non-repudiation
signature_hash: str # Hash of signature components
certificate_id: Optional[str] # Digital certificate if used
7.2 System Validation Documentation
class SystemValidation:
"""IQ/OQ/PQ validation documentation for Part 11."""
class ValidationType(Enum):
IQ = "installation_qualification"
OQ = "operational_qualification"
PQ = "performance_qualification"
id: UUID
validation_type: ValidationType
system_name: str
system_version: str
# Protocol
protocol_document_id: UUID
protocol_approved_by: UUID
protocol_approved_at: datetime
# Execution
executed_by: UUID
executed_at: datetime
execution_results: list[dict] # Test results
# Deviations
deviations: list[dict] # Any deviations from protocol
deviation_resolutions: list[dict]
# Approval
status: Literal["draft", "executed", "approved", "effective"]
approved_by: UUID
approved_at: Optional[datetime]
effective_date: Optional[datetime]
# Periodic review
next_review_date: datetime
review_frequency: Literal["annual", "biennial", "change_triggered"]
8. Legal Hold Management
8.1 Legal Hold Specification
class LegalHold:
"""Legal hold management for litigation/investigation."""
id: UUID
hold_name: str
matter_name: str # Legal matter/case name
matter_number: Optional[str] # External case number
# Scope
custodians: list[UUID] # Users under hold
document_criteria: dict # Search criteria for docs
date_range_start: Optional[datetime]
date_range_end: Optional[datetime]
# Status
status: Literal["active", "released", "expired"]
created_by: UUID # Legal/compliance officer
created_at: datetime
released_by: Optional[UUID]
released_at: Optional[datetime]
release_reason: Optional[str]
# Documents
documents_held: list[UUID]
hold_acknowledgments: list[dict] # Custodian acknowledgments
# Prevents
prevents_deletion: bool = True
prevents_modification: bool = False # Usually allows viewing
prevents_export: bool = False
8.2 Legal Hold API
# Create legal hold
POST /api/v1/compliance/legal-holds
{
"hold_name": "Patent Litigation 2025",
"matter_name": "Acme Corp v. Widget Inc",
"custodians": ["user-uuid-1", "user-uuid-2"],
"document_criteria": {
"document_types": ["email", "contract"],
"date_range": {
"start": "2023-01-01",
"end": "2025-12-31"
},
"keywords": ["patent", "widget", "invention"]
},
"prevents_deletion": true
}
# Acknowledge hold (by custodian)
POST /api/v1/compliance/legal-holds/{hold_id}/acknowledge
{
"acknowledged": true,
"electronic_signature": {
"signature_meaning": "acknowledged",
"password": "..."
}
}
# Release hold
POST /api/v1/compliance/legal-holds/{hold_id}/release
{
"release_reason": "Litigation settled",
"authorized_by": "legal-counsel-user-id"
}
9. Immutable Audit Trail
9.1 Blockchain-Anchored Audit Log
class ImmutableAuditLog:
"""Tamper-evident audit trail with blockchain anchoring."""
def log_event(self, event: AuditEvent) -> AuditLogEntry:
"""Create immutable audit log entry."""
# 1. Get previous entry hash (chain)
previous_hash = self.get_latest_hash()
# 2. Create entry with hash chain
entry = AuditLogEntry(
event_id=uuid4(),
timestamp=datetime.utcnow(),
event_data=event.dict(),
previous_hash=previous_hash,
entry_hash=self.compute_hash(event, previous_hash)
)
# 3. Store in append-only database
self.store_entry(entry)
# 4. Periodically anchor to blockchain (batch)
if self.should_anchor():
self.anchor_to_blockchain(entry.entry_hash)
return entry
def compute_hash(
self,
event: AuditEvent,
previous_hash: str
) -> str:
"""Compute SHA-256 hash for chain integrity."""
data = f"{event.json()}{previous_hash}{datetime.utcnow().isoformat()}"
return hashlib.sha256(data.encode()).hexdigest()
def verify_integrity(self, start_id: UUID, end_id: UUID) -> bool:
"""Verify audit log integrity for a range of entries."""
entries = self.get_entries(start_id, end_id)
for i, entry in enumerate(entries):
# Verify hash chain
expected_hash = self.compute_hash(
entry.event_data,
entries[i-1].entry_hash if i > 0 else "genesis"
)
if entry.entry_hash != expected_hash:
return False
return True
10. Compliance Dashboard
10.1 Dashboard Components
interface ComplianceDashboard {
// Overall compliance score
overallScore: number; // 0-100
// By framework
frameworkScores: {
hipaa: ComplianceScore;
sox: ComplianceScore;
gdpr: ComplianceScore;
fda_part11: ComplianceScore;
};
// Open items
openDataSubjectRequests: number;
pendingRetentionActions: number;
activeLegalHolds: number;
overdueTraining: number;
// Recent activity
recentAuditEvents: AuditEvent[];
recentComplianceAlerts: Alert[];
// Upcoming deadlines
upcomingDeadlines: Deadline[];
}
interface ComplianceScore {
score: number;
status: 'compliant' | 'at_risk' | 'non_compliant';
openFindings: number;
lastAssessmentDate: Date;
nextAssessmentDate: Date;
}
10.2 Compliance Reports
# Generate compliance report
POST /api/v1/compliance/reports
{
"report_type": "hipaa_annual_assessment",
"period_start": "2025-01-01",
"period_end": "2025-12-31",
"include_sections": [
"access_controls",
"audit_logs",
"encryption_status",
"training_completion",
"incident_summary",
"baa_status"
],
"format": "pdf"
}
Response:
{
"report_id": "uuid",
"status": "generating",
"estimated_completion": "2025-12-19T15:00:00Z",
"download_url": null // Available when complete
}
11. Implementation Checklist
11.1 Phase 1: Foundation (Weeks 1-4)
- Implement MFA module with TOTP support
- Create retention policy engine
- Build immutable audit log with hash chaining
- Implement document classification system
- Create compliance configuration management
11.2 Phase 2: GDPR & HIPAA (Weeks 5-8)
- Implement data subject request workflow
- Build right to erasure (RTBF) processor
- Create data portability export
- Implement PHI detection and classification
- Build BAA management workflow
11.3 Phase 3: SOX & FDA (Weeks 9-12)
- Implement ICFR control tracking
- Build management attestation workflow
- Create Part 11 electronic signatures
- Implement system validation documentation
- Build legal hold management
11.4 Phase 4: Dashboard & Reporting (Weeks 13-16)
- Create compliance dashboard
- Build automated compliance reports
- Implement real-time compliance alerts
- Create audit trail verification tools
- Build training tracking integration
12. Database Schema Extensions
-- Retention policies
CREATE TABLE retention_policies (
id UUID PRIMARY KEY,
name VARCHAR(255) NOT NULL,
retention_days INTEGER NOT NULL,
retention_trigger VARCHAR(50) NOT NULL,
expiration_action VARCHAR(50) NOT NULL,
compliance_frameworks JSONB,
created_at TIMESTAMP WITH TIME ZONE DEFAULT NOW(),
updated_at TIMESTAMP WITH TIME ZONE DEFAULT NOW()
);
-- Legal holds
CREATE TABLE legal_holds (
id UUID PRIMARY KEY,
hold_name VARCHAR(255) NOT NULL,
matter_name VARCHAR(255) NOT NULL,
status VARCHAR(50) NOT NULL DEFAULT 'active',
document_criteria JSONB,
custodians UUID[],
created_by UUID REFERENCES users(id),
created_at TIMESTAMP WITH TIME ZONE DEFAULT NOW(),
released_at TIMESTAMP WITH TIME ZONE,
released_by UUID REFERENCES users(id)
);
-- Data subject requests (GDPR)
CREATE TABLE data_subject_requests (
id UUID PRIMARY KEY,
request_type VARCHAR(50) NOT NULL,
data_subject_email VARCHAR(255) NOT NULL,
status VARCHAR(50) NOT NULL DEFAULT 'received',
received_at TIMESTAMP WITH TIME ZONE DEFAULT NOW(),
due_date TIMESTAMP WITH TIME ZONE NOT NULL,
completed_at TIMESTAMP WITH TIME ZONE,
processing_log JSONB DEFAULT '[]'
);
-- Immutable audit log
CREATE TABLE audit_log (
id UUID PRIMARY KEY,
timestamp TIMESTAMP WITH TIME ZONE DEFAULT NOW(),
event_type VARCHAR(100) NOT NULL,
user_id UUID,
document_id UUID,
event_data JSONB NOT NULL,
previous_hash VARCHAR(64) NOT NULL,
entry_hash VARCHAR(64) NOT NULL,
blockchain_anchor VARCHAR(255)
);
-- Create index for hash chain verification
CREATE INDEX idx_audit_log_hash ON audit_log(entry_hash);
CREATE INDEX idx_audit_log_timestamp ON audit_log(timestamp);
-- Electronic signatures (Part 11)
CREATE TABLE electronic_signatures (
id UUID PRIMARY KEY,
document_id UUID NOT NULL REFERENCES documents(id),
document_version VARCHAR(50) NOT NULL,
user_id UUID NOT NULL REFERENCES users(id),
signature_meaning VARCHAR(50) NOT NULL,
signed_at TIMESTAMP WITH TIME ZONE DEFAULT NOW(),
document_hash VARCHAR(64) NOT NULL,
signature_hash VARCHAR(64) NOT NULL
);
Document Version: 1.0.0 Effective Date: Upon Approval Review Date: Quarterly Owner: Compliance Team