{
  "schema_version": "1.0.0",
  "description": "Pre-built finding scenarios for mock internal audits. Each scenario has theme + severity + applicable_frameworks tags; cross-reference scripts/cross_framework_mapper.py merged-controls catalogue to resolve framework-specific control IDs.",
  "supported_frameworks": [
    "iso_27001", "iso_13485", "iso_42001", "iso_14971",
    "eu_ai_act", "eu_mdr_745", "gdpr", "soc_2", "fda_qsr",
    "nist_csf", "nis2", "hipaa"
  ],
  "severity_levels": {
    "critical": "Major nonconformity: absence of, or systemic failure to implement, a required management-system process. Blocks certification at stage 1.",
    "major": "Material gap in a required control. Corrective action plan within 30 days.",
    "minor": "Localized gap; control works overall. Corrective action within 90 days.",
    "observation": "Improvement opportunity; no nonconformity. Optional recommendation."
  },
  "scenarios": [
    {"id": "F-AC-001", "theme": "access_control", "severity": "critical", "title": "Orphaned privileged access from terminations", "description": "Quarterly access review missed 3 cycles; 12 terminated employees retain prod admin access > 90 days post-termination. Audit log shows 4 of them performed actions in the system after their last working day.", "remediation": "Immediate revocation; investigate access logs for unauthorized activity; reinstate quarterly review cadence with automated tooling.", "remediation_days": 14, "applicable_frameworks": ["iso_27001", "soc_2", "iso_42001", "gdpr", "nist_csf", "hipaa", "nis2"]},
    {"id": "F-AC-002", "theme": "access_control", "severity": "critical", "title": "Shared admin credentials in production", "description": "Production database admin password shared across 5 engineers; rotation last performed > 12 months ago. No audit trail for individual actions.", "remediation": "Rotate immediately; provision per-user named accounts; enable individual audit logging; document procedure.", "remediation_days": 7, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa", "nis2"]},
    {"id": "F-AC-003", "theme": "access_control", "severity": "major", "title": "Quarterly access review evidence lacks justification", "description": "Quarterly access review records exist but lack documented business justification for retained privileges. Reviewers approve in bulk without per-user rationale.", "remediation": "Update review template to require per-user justification; train reviewers; sample-check next quarter.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "nist_csf"]},
    {"id": "F-AC-004", "theme": "access_control", "severity": "major", "title": "JML workflow does not auto-deprovision", "description": "Joiner-mover-leaver workflow exists but is manual; observed 5+ day gap between HR termination and access revocation.", "remediation": "Implement IDP integration with HR system for auto-deprovisioning within 24 hours; trail for exceptions.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "iso_42001", "gdpr", "hipaa", "nis2"]},
    {"id": "F-AC-005", "theme": "access_control", "severity": "major", "title": "MFA not enforced on admin accounts", "description": "Multi-factor authentication is documented in policy but not technically enforced on cloud admin accounts; 8 admin users authenticate without MFA.", "remediation": "Enforce MFA at IDP level; emergency-break-glass procedure documented; close legacy accounts.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa", "nis2", "gdpr"]},
    {"id": "F-AC-006", "theme": "access_control", "severity": "minor", "title": "Access review records lack completion timestamps", "description": "Access review records lack documented review-completion timestamps in 2 of 6 sampled reviews. Cannot confirm review was completed on time.", "remediation": "Update review tooling to capture timestamp at review-action time; backfill where possible.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa"]},
    {"id": "F-AC-007", "theme": "access_control", "severity": "minor", "title": "RBAC matrix doesn't cover cloud resources", "description": "Role-based access control matrix exists for application tier but does not address cloud-resource scope (IAM policies, S3 buckets, KMS keys).", "remediation": "Extend RBAC matrix; document cloud-IAM role-to-business-role mapping.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-AC-008", "theme": "access_control", "severity": "observation", "title": "Consider just-in-time (JIT) access for production", "description": "Standing access to production is the default; JIT access with approval workflow would reduce blast radius and improve audit trail.", "remediation": "Pilot JIT tooling (e.g., Teleport, ConductorOne, ConsoleMe) for one team.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-AC-009", "theme": "access_control", "severity": "observation", "title": "Privileged access review cadence could be more frequent", "description": "Quarterly cadence meets standard; for ≥ critical-tier systems, monthly review provides earlier detection of orphaned access.", "remediation": "Increase cadence for critical-tier systems to monthly.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "nist_csf"]},
    {"id": "F-AC-010", "theme": "access_control", "severity": "observation", "title": "Session timeout policies inconsistent", "description": "Session-timeout policies vary across applications (30 min in CRM, 8 hours in BI tool, no timeout in internal admin tool). Inconsistent risk posture.", "remediation": "Define policy by data sensitivity tier; align tooling configuration.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa"]},

    {"id": "F-AI-001", "theme": "asset_inventory", "severity": "major", "title": "Asset inventory missing cloud + SaaS + AI tools", "description": "Asset register includes server inventory but omits 60% of SaaS tools and 100% of AI/LLM tools acquired in past 12 months. No central source of truth.", "remediation": "Integrate SSO with SaaS-discovery tooling; require AI-tool registration before procurement; quarterly refresh.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "iso_42001", "nist_csf", "gdpr"]},
    {"id": "F-AI-002", "theme": "asset_inventory", "severity": "major", "title": "Data classification scheme not applied", "description": "Data classification scheme documented (public / internal / confidential / restricted) but only 30% of data stores have classification labels applied.", "remediation": "Apply classification to remaining stores; automate via DLP tooling where feasible.", "remediation_days": 120, "applicable_frameworks": ["iso_27001", "soc_2", "gdpr", "hipaa", "nist_csf"]},
    {"id": "F-AI-003", "theme": "asset_inventory", "severity": "minor", "title": "Asset owners not assigned for 15% of assets", "description": "15% of inventory entries lack named owners; orphan ownership impedes timely incident response.", "remediation": "Assign owners; require owner field on new asset creation.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-AI-004", "theme": "asset_inventory", "severity": "minor", "title": "Third-party AI services not tagged in inventory", "description": "Inventory does not flag which assets are powered by third-party AI services (e.g., OpenAI, Anthropic, Cohere). Material for ISO 42001 A.10 + EU AI Act Article 25.", "remediation": "Add AI-vendor tag; update procurement intake form.", "remediation_days": 90, "applicable_frameworks": ["iso_42001", "eu_ai_act", "iso_27001"]},
    {"id": "F-AI-005", "theme": "asset_inventory", "severity": "observation", "title": "Asset decommissioning workflow informal", "description": "When assets are decommissioned, data destruction is documented but inventory entries persist; clutters reporting.", "remediation": "Add decommission state to inventory schema; archive after retention period.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa"]},

    {"id": "F-RM-001", "theme": "risk_management", "severity": "critical", "title": "Risk register without treatment plans", "description": "Risk register identifies 30+ risks but lacks documented treatment plans (modify/share/retain/avoid per ISO 23894) for high/critical risks.", "remediation": "Run risk-treatment workshop per high/critical risk; document treatment + signoff; link to specific controls.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "iso_42001", "soc_2", "nist_csf", "nis2", "hipaa"]},
    {"id": "F-RM-002", "theme": "risk_management", "severity": "critical", "title": "AI risk assessment not re-run after material model change", "description": "AI risk assessment last performed at initial deployment 18 months ago. Model has been retrained twice; risk profile not re-evaluated.", "remediation": "Trigger re-assessment; update register; document drift monitoring threshold; commit to re-assessment on every material change.", "remediation_days": 45, "applicable_frameworks": ["iso_42001", "eu_ai_act"]},
    {"id": "F-RM-003", "theme": "risk_management", "severity": "major", "title": "Risk methodology inconsistently applied", "description": "Different teams use different risk-scoring methodologies; severity scores not comparable across the register.", "remediation": "Standardize on single methodology (e.g., 5x5 likelihood × impact matrix); train risk owners; re-score existing register.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_14971", "nist_csf", "soc_2"]},
    {"id": "F-RM-004", "theme": "risk_management", "severity": "major", "title": "Residual risk acceptance lacks management signoff", "description": "30% of 'retain' risk-treatment decisions lack documented management signoff. Some retain decisions made by individual contributors.", "remediation": "Define signoff matrix by severity; backfill where possible; route remaining retain decisions through proper authority.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_14971", "nis2", "hipaa"]},
    {"id": "F-RM-005", "theme": "risk_management", "severity": "major", "title": "Risk register not updated for 6+ months", "description": "Risk register last refreshed > 6 months ago. New risks from product changes, new vendors, regulatory developments not captured.", "remediation": "Refresh; commit to quarterly cadence minimum.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "iso_42001", "nist_csf", "nis2"]},
    {"id": "F-RM-006", "theme": "risk_management", "severity": "minor", "title": "DPIA exists but Article 35(7) elements incomplete", "description": "DPIA documented for high-risk processing but does not cover all Article 35(7)(a)-(d) required elements (missing necessity + proportionality assessment).", "remediation": "Update DPIA template; refresh affected DPIAs.", "remediation_days": 60, "applicable_frameworks": ["gdpr", "iso_42001"]},
    {"id": "F-RM-007", "theme": "risk_management", "severity": "minor", "title": "Risk treatment plans lack effective-date tracking", "description": "Treatment plans are documented but lack effective-date or expected-completion fields; cannot track remediation timeliness.", "remediation": "Add date fields; update existing entries.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "soc_2"]},
    {"id": "F-RM-008", "theme": "risk_management", "severity": "observation", "title": "Consider FAIR quantitative risk methodology for top-tier risks", "description": "Current methodology is qualitative; quantitative analysis (e.g., Open FAIR) for top-5 risks would improve decision quality.", "remediation": "Pilot FAIR on 2-3 top risks.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "nist_csf"]},
    {"id": "F-RM-009", "theme": "risk_management", "severity": "observation", "title": "Risk-related KPIs not reported to executive", "description": "Risk register exists but no rolled-up KPIs (e.g., # critical risks open, mean time to treatment) reported in management review.", "remediation": "Add risk KPIs to management review inputs.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "iso_42001", "nist_csf"]},

    {"id": "F-SM-001", "theme": "supplier_management", "severity": "critical", "title": "Critical SaaS in use without DPA", "description": "Critical SaaS supplier (handles personal data of 500K+ users) in use without signed DPA per GDPR Article 28. Pre-existing arrangement not refreshed since 2018.", "remediation": "Engage vendor for DPA execution; if vendor refuses, evaluate replacement.", "remediation_days": 30, "applicable_frameworks": ["gdpr", "iso_27001", "soc_2", "hipaa"]},
    {"id": "F-SM-002", "theme": "supplier_management", "severity": "critical", "title": "Business Associate Agreement missing for HIPAA-relevant vendor", "description": "Vendor processes PHI on behalf of the organization but no signed Business Associate Agreement (BAA) per HIPAA §164.314(a). Material exposure.", "remediation": "Sign BAA; if vendor refuses, evaluate replacement; document remediation timeline.", "remediation_days": 30, "applicable_frameworks": ["hipaa", "iso_27001"]},
    {"id": "F-SM-003", "theme": "supplier_management", "severity": "major", "title": "Annual supplier reviews incomplete", "description": "Annual supplier security review not completed for 3 of 8 critical suppliers in past year.", "remediation": "Run overdue reviews; calendar future reviews; document escalation for non-responsive vendors.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "iso_42001", "hipaa", "nis2", "gdpr"]},
    {"id": "F-SM-004", "theme": "supplier_management", "severity": "major", "title": "Sub-processor list not maintained", "description": "Critical supplier handling personal data uses sub-processors; the sub-processor list is not maintained or available; GDPR Article 28(2) not satisfied.", "remediation": "Request sub-processor list from vendor; establish change notification mechanism; document.", "remediation_days": 60, "applicable_frameworks": ["gdpr", "iso_27001", "nist_csf"]},
    {"id": "F-SM-005", "theme": "supplier_management", "severity": "major", "title": "AI-specific contract clauses not in vendor agreements", "description": "Third-party AI service in use; contract lacks AI-specific clauses (training-data use restrictions, drift notification, sub-processor list for AI sub-services).", "remediation": "Negotiate addendum; document acceptance.", "remediation_days": 90, "applicable_frameworks": ["iso_42001", "eu_ai_act", "iso_27001"]},
    {"id": "F-SM-006", "theme": "supplier_management", "severity": "major", "title": "Supplier exit / termination procedure not documented", "description": "No procedure for safe vendor exit (data return, model deletion, monitoring transition). Discovered during attempt to terminate one supplier.", "remediation": "Draft procedure; pilot on next vendor termination; document.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "iso_42001", "soc_2", "gdpr"]},
    {"id": "F-SM-007", "theme": "supplier_management", "severity": "minor", "title": "Vendor onboarding checklist applied inconsistently", "description": "Supplier onboarding checklist exists but is bypassed in 'urgent' procurements; 4 of 12 recent vendors lack complete onboarding evidence.", "remediation": "Make checklist mandatory at procurement gate; remediate gaps in existing 4.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-SM-008", "theme": "supplier_management", "severity": "minor", "title": "Supplier SOC 2 reports collected but not reviewed", "description": "Critical suppliers' SOC 2 Type II reports collected on initial onboarding but not reviewed annually as new reports issued.", "remediation": "Set calendar for annual review; document key findings + acceptance.", "remediation_days": 60, "applicable_frameworks": ["soc_2", "iso_27001"]},
    {"id": "F-SM-009", "theme": "supplier_management", "severity": "observation", "title": "Consider centralizing supplier risk evidence in GRC tool", "description": "Supplier evidence scattered across procurement Drive, Compliance Drive, and email. Centralization in GRC tool would reduce audit prep effort.", "remediation": "Evaluate GRC tooling; migrate over 6 months.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "iso_42001"]},
    {"id": "F-SM-010", "theme": "supplier_management", "severity": "observation", "title": "Vendor risk-tiering could be more granular", "description": "Vendors tier as 'critical / non-critical' currently; more granular tiers (e.g., based on data type, criticality, integration depth) would refine review cadence.", "remediation": "Define 3-tier model; reclassify existing inventory.", "remediation_days": 120, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa"]},

    {"id": "F-IR-001", "theme": "incident_response", "severity": "critical", "title": "GDPR Article 33 breach notification missed", "description": "Breach occurred 96 hours ago; supervisory authority not notified despite Article 33 72-hour requirement. Investigation revealed unclear breach-criteria decision.", "remediation": "File notification immediately with rationale for delay; review breach-criteria decision tree; conduct tabletop exercise; document.", "remediation_days": 7, "applicable_frameworks": ["gdpr", "iso_27001", "hipaa", "nis2"]},
    {"id": "F-IR-002", "theme": "incident_response", "severity": "critical", "title": "Recent P1 incident lacks PIR within SLA", "description": "P1 production incident occurred 45 days ago; post-incident review (PIR) not documented within stated 30-day SLA.", "remediation": "Complete PIR immediately; identify corrective actions; calendar future PIRs.", "remediation_days": 14, "applicable_frameworks": ["iso_27001", "soc_2", "iso_42001", "nist_csf"]},
    {"id": "F-IR-003", "theme": "incident_response", "severity": "critical", "title": "Severity definitions inconsistently applied", "description": "Severity definitions documented but inconsistently applied across teams; impact analysis varies. Two recent P2 incidents arguably P1 by definition.", "remediation": "Train responders on severity rubric; calibration exercise quarterly; track severity-classification consistency.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "iso_42001", "gdpr", "hipaa"]},
    {"id": "F-IR-004", "theme": "incident_response", "severity": "major", "title": "Notification SLAs not aligned across frameworks", "description": "GDPR 72h, NIS2 24h-early-warning + 72h-notification, EU AI Act 15-day (or 2-day critical-infra), HIPAA 60-day. Internal procedures collapse to a single 'breach' notification without per-framework branching.", "remediation": "Update IR procedure to branch by applicable framework; train responders.", "remediation_days": 60, "applicable_frameworks": ["gdpr", "nis2", "eu_ai_act", "hipaa", "iso_27001"]},
    {"id": "F-IR-005", "theme": "incident_response", "severity": "major", "title": "Incident commander rotation not documented", "description": "Incident commander rotation exists informally but is not documented; recent incidents had ambiguous IC ownership.", "remediation": "Document rotation; publish on-call schedule.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-IR-006", "theme": "incident_response", "severity": "major", "title": "Breach log incomplete per Article 33(5)", "description": "GDPR breach log captures only DPA-notifiable events; Article 33(5) requires ALL breaches logged regardless of notifiability.", "remediation": "Update breach log scope; backfill recent breaches; train DPO on requirement.", "remediation_days": 60, "applicable_frameworks": ["gdpr", "iso_27001", "hipaa"]},
    {"id": "F-IR-007", "theme": "incident_response", "severity": "major", "title": "Detection mechanism gaps", "description": "Mean time to detect (MTTD) for past 3 incidents averaged 8 days; SIEM rules not tuned for recently-onboarded systems.", "remediation": "Audit SIEM coverage; tune rules; test detection for high-impact attack scenarios.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "nis2"]},
    {"id": "F-IR-008", "theme": "incident_response", "severity": "minor", "title": "Tabletop exercise not conducted in last 12 months", "description": "Annual incident-response tabletop exercise not performed in past 12 months.", "remediation": "Schedule + run tabletop; document lessons learned.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "nis2", "hipaa"]},
    {"id": "F-IR-009", "theme": "incident_response", "severity": "minor", "title": "Customer notification timing not tracked", "description": "Customer-facing incident notifications sent but timing not tracked against committed SLA. Cannot demonstrate SLA compliance.", "remediation": "Track notification timestamps; report against SLA quarterly.", "remediation_days": 60, "applicable_frameworks": ["soc_2", "iso_27001", "gdpr"]},
    {"id": "F-IR-010", "theme": "incident_response", "severity": "observation", "title": "Consider chaos engineering for resilience testing", "description": "Incident response prepares for failures; chaos engineering would proactively surface latent weaknesses.", "remediation": "Pilot chaos engineering on non-prod first; expand if mature.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-ML-001", "theme": "monitoring_logging", "severity": "critical", "title": "Production application logs disabled", "description": "Production application logs disabled in past 30 days due to disk space; not detected until audit fieldwork. 30-day blind spot.", "remediation": "Re-enable; resize storage; alert on log volume drops; investigate any incidents during blind period.", "remediation_days": 7, "applicable_frameworks": ["iso_27001", "soc_2", "iso_42001", "hipaa", "nist_csf"]},
    {"id": "F-ML-002", "theme": "monitoring_logging", "severity": "major", "title": "Log retention misaligned with framework requirement", "description": "Log retention configured at 90 days; ISO 27001 + framework requirements expect 12 months minimum for some logs.", "remediation": "Update retention configuration; backfill from archives where feasible; document policy.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "nist_csf", "gdpr"]},
    {"id": "F-ML-003", "theme": "monitoring_logging", "severity": "major", "title": "Tamper-evident logging not enforced", "description": "Tamper-evident logging not enforced on privileged-user activity logs; logs writable to same store as application data.", "remediation": "Move logs to write-once storage; document architecture; verify immutability.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "nist_csf", "nis2"]},
    {"id": "F-ML-004", "theme": "monitoring_logging", "severity": "major", "title": "AI model drift not monitored", "description": "AI system in production; no drift monitoring against original validation data. No defined drift threshold for retraining.", "remediation": "Implement drift monitoring; define threshold; escalation path.", "remediation_days": 90, "applicable_frameworks": ["iso_42001", "eu_ai_act"]},
    {"id": "F-ML-005", "theme": "monitoring_logging", "severity": "minor", "title": "Monitoring alert thresholds not documented", "description": "Monitoring alert thresholds exist in tooling but not documented; rationale unclear.", "remediation": "Document thresholds + rationale + on-call response action.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-ML-006", "theme": "monitoring_logging", "severity": "minor", "title": "Cloud audit logs not centralized", "description": "Cloud audit logs (CloudTrail/Cloud Audit Logs) exist per account but not centralized to SIEM; cross-account analysis manual.", "remediation": "Forward logs to central SIEM; configure cross-account analysis.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-ML-007", "theme": "monitoring_logging", "severity": "observation", "title": "Consider anomaly detection on top of rule-based monitoring", "description": "Current monitoring is rule-based; anomaly detection (statistical or ML-based) would surface novel patterns.", "remediation": "Pilot on key data flows.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-CM-001", "theme": "change_management", "severity": "critical", "title": "Emergency change procedure not formalized", "description": "Emergency change procedure not documented; observed 3 cases of production changes in past 30 days without recorded approval. Two affected customer data.", "remediation": "Draft emergency change procedure including retroactive review; train engineers; audit recent emergency changes.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "soc_2", "iso_13485", "hipaa", "nist_csf"]},
    {"id": "F-CM-002", "theme": "change_management", "severity": "major", "title": "Change advisory board rubber-stamps", "description": "Change advisory board records show approvals but zero rejected changes in last 6 months. Board likely not exercising substantive review.", "remediation": "Calibration training for board; track reject + revise rate; ensure reviewers have time + context.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "iso_13485"]},
    {"id": "F-CM-003", "theme": "change_management", "severity": "major", "title": "Rollback procedure not tested", "description": "Rollback procedure documented but not tested for 2 services in audit scope. Cannot confirm operability.", "remediation": "Test rollback in staging; document; schedule quarterly verification.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "iso_13485", "nist_csf"]},
    {"id": "F-CM-004", "theme": "change_management", "severity": "minor", "title": "Post-implementation reviews skipped for high-risk changes", "description": "Change advisory board records show approvals but no post-implementation review for high-risk changes (defined by impact rubric).", "remediation": "Reinstate post-implementation review for high-risk; define follow-up timeline.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "iso_13485"]},
    {"id": "F-CM-005", "theme": "change_management", "severity": "observation", "title": "Link change records to deployment automation", "description": "Change records and deployment automation are separate systems; linking would strengthen evidence chain.", "remediation": "Integrate via deployment tagging.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-BC-001", "theme": "business_continuity", "severity": "critical", "title": "BCP/DRP exists but never tested", "description": "Business continuity + disaster recovery plans exist on paper but no recovery exercise in 24+ months. Untested = ineffective.", "remediation": "Conduct full DR exercise; document results; commit to annual exercise cadence.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "nis2", "hipaa"]},
    {"id": "F-BC-002", "theme": "business_continuity", "severity": "major", "title": "RPO/RTO objectives not measured", "description": "Recovery objectives defined but not measured during recent failover events. Cannot confirm objectives are achievable.", "remediation": "Measure during next exercise; tune objectives or recovery capability.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa"]},
    {"id": "F-BC-003", "theme": "business_continuity", "severity": "major", "title": "Backup integrity not verified", "description": "Backups occur but restoration testing not performed in past 12 months. Cannot confirm backups are usable.", "remediation": "Quarterly restoration tests; document verification evidence.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "nis2"]},
    {"id": "F-BC-004", "theme": "business_continuity", "severity": "minor", "title": "BCP doesn't address third-party SaaS outage", "description": "BCP covers self-hosted infrastructure; doesn't address critical SaaS-vendor outage scenarios.", "remediation": "Extend BCP for SaaS outage scenarios; document vendor SLAs + alternatives.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "nis2"]},
    {"id": "F-BC-005", "theme": "business_continuity", "severity": "observation", "title": "Consider chaos game-day exercises", "description": "Annual DR exercise meets standard; chaos game-day adds value by testing under more realistic conditions.", "remediation": "Pilot game-day for one service.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-CT-001", "theme": "competence_training", "severity": "major", "title": "Annual security training not 100% complete", "description": "Annual security training completion is 89% across the company; 12 employees past due > 30 days.", "remediation": "Escalate to managers for non-completers; revoke access for chronic non-completers; document policy.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa", "nis2"]},
    {"id": "F-CT-002", "theme": "competence_training", "severity": "major", "title": "AI literacy training not in place", "description": "EU AI Act Article 4 requires AI literacy for staff dealing with AI systems; no AI-specific training implemented.", "remediation": "Develop + roll out AI literacy training; track completion by role.", "remediation_days": 90, "applicable_frameworks": ["eu_ai_act", "iso_42001"]},
    {"id": "F-CT-003", "theme": "competence_training", "severity": "major", "title": "Competence requirements undefined for ML engineers", "description": "Competence requirements defined for engineering roles but not specifically for ML engineers; assumes 'they have degrees'.", "remediation": "Define ML-engineer competence requirements; verify against existing staff.", "remediation_days": 90, "applicable_frameworks": ["iso_42001"]},
    {"id": "F-CT-004", "theme": "competence_training", "severity": "minor", "title": "Training effectiveness verification missing", "description": "Training completion recorded but effectiveness verification (assessment, simulation, observed behavior) not performed.", "remediation": "Add post-training assessment; track scores.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_13485", "soc_2"]},
    {"id": "F-CT-005", "theme": "competence_training", "severity": "observation", "title": "Consider role-based training tiers", "description": "Training is uniform across roles; role-based tiers would surface compliance-officer-specific, dev-specific, etc.", "remediation": "Design role-tiered curriculum.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-DG-001", "theme": "data_governance", "severity": "critical", "title": "Training data lacks provenance records", "description": "AI training data sourced from multiple vendors + scraped sources; no provenance records. EU AI Act Article 10(2)(d) + ISO 42001 A.7.4 not satisfied.", "remediation": "Audit current training data; document provenance per source; remove data without verifiable provenance.", "remediation_days": 90, "applicable_frameworks": ["iso_42001", "eu_ai_act", "gdpr"]},
    {"id": "F-DG-002", "theme": "data_governance", "severity": "critical", "title": "PII in training data without lawful basis", "description": "Training data contains PII; lawful basis (GDPR Article 6) not documented for AI training use case. Article 10(5) AI Act bias-detection exception not applicable here.", "remediation": "Document lawful basis or remove PII; if legitimate interests, document LIA; halt training until resolved.", "remediation_days": 30, "applicable_frameworks": ["gdpr", "iso_42001", "eu_ai_act"]},
    {"id": "F-DG-003", "theme": "data_governance", "severity": "major", "title": "Data quality dimensions not defined", "description": "Data quality monitoring exists but dimensions (completeness, accuracy, timeliness, consistency) not formally defined. Audit against ISO 42001 A.7.3 incomplete.", "remediation": "Define dimensions per data store; document measurement methodology.", "remediation_days": 90, "applicable_frameworks": ["iso_42001", "iso_27001", "gdpr"]},
    {"id": "F-DG-004", "theme": "data_governance", "severity": "major", "title": "Article 30 RoPA stale", "description": "GDPR Article 30 records of processing activities last refreshed 8 months ago; new processing activities not captured.", "remediation": "Refresh RoPA; commit to quarterly updates; integrate with new-feature intake.", "remediation_days": 60, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DG-005", "theme": "data_governance", "severity": "major", "title": "Retention schedules not enforced", "description": "Data retention schedules documented but not enforced in tooling. Data persists beyond stated retention.", "remediation": "Implement automated retention enforcement; backfill cleanup; document deletions.", "remediation_days": 90, "applicable_frameworks": ["gdpr", "iso_27001", "hipaa", "iso_42001"]},
    {"id": "F-DG-006", "theme": "data_governance", "severity": "minor", "title": "Consent management workflow lacks withdrawal mechanism", "description": "Consent collected at signup; withdrawal mechanism exists in privacy notice but not technically implemented.", "remediation": "Implement self-service consent withdrawal; honour within reasonable time.", "remediation_days": 90, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DG-007", "theme": "data_governance", "severity": "observation", "title": "Consider data lineage tooling", "description": "Data flows documented manually; data-lineage tooling would automate + maintain freshness.", "remediation": "Evaluate tooling (e.g., OpenLineage, DataHub, Atlan).", "remediation_days": 180, "applicable_frameworks": ["iso_42001", "gdpr"]},

    {"id": "F-CR-001", "theme": "cryptography", "severity": "major", "title": "Encryption at rest using deprecated algorithm", "description": "Some data stores still use deprecated AES-128 (or 3DES); current standard expects AES-256.", "remediation": "Plan migration; document; complete within 6 months.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa", "nis2", "gdpr"]},
    {"id": "F-CR-002", "theme": "cryptography", "severity": "major", "title": "Key rotation not enforced", "description": "Cryptographic key rotation policy exists (annual) but not enforced; production keys 3+ years old.", "remediation": "Rotate immediately; automate rotation via KMS; document.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa", "nis2", "gdpr"]},
    {"id": "F-CR-003", "theme": "cryptography", "severity": "major", "title": "TLS configuration permits deprecated versions", "description": "TLS 1.0 + 1.1 still accepted on public endpoints; current standard expects TLS 1.2 minimum.", "remediation": "Disable TLS 1.0 + 1.1; verify all clients support 1.2+; document.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa", "nis2", "gdpr"]},
    {"id": "F-CR-004", "theme": "cryptography", "severity": "minor", "title": "Cryptographic inventory incomplete", "description": "Cryptographic inventory exists but lacks documentation of algorithm + key length per data store.", "remediation": "Audit each store; document; flag deprecated algorithms.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "nist_csf", "hipaa"]},
    {"id": "F-CR-005", "theme": "cryptography", "severity": "observation", "title": "Consider post-quantum cryptography roadmap", "description": "Current crypto is RSA + ECC; post-quantum standards finalized in 2024. Long-term planning for migration recommended.", "remediation": "Define PQC migration roadmap.", "remediation_days": 365, "applicable_frameworks": ["iso_27001", "nist_csf", "nis2"]},

    {"id": "F-SD-001", "theme": "secure_sdlc", "severity": "critical", "title": "Production deploy without SAST results", "description": "Recent production deploys lack SAST scan evidence; SAST configured in CI but bypassed via manual override.", "remediation": "Make SAST a required gate; remove override capability for production; investigate bypassed deploys.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-SD-002", "theme": "secure_sdlc", "severity": "major", "title": "Code review records inconsistent", "description": "Some commits to main branch lack documented review; review-required branch protection not consistently enforced.", "remediation": "Enforce review on protected branches across all repos; audit recent commits.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-SD-003", "theme": "secure_sdlc", "severity": "major", "title": "Threat modeling not performed for new services", "description": "New service launched last quarter without threat model. ISO 27001 A.8.25-31 + secure-by-design expectations not met.", "remediation": "Retroactive threat model; integrate threat modeling into design-review gate.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "nis2"]},
    {"id": "F-SD-004", "theme": "secure_sdlc", "severity": "minor", "title": "Dependency scanning missing for some repos", "description": "Dependency scanning configured for production services but not for internal tools.", "remediation": "Extend dependency scanning to all repos.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-SD-005", "theme": "secure_sdlc", "severity": "observation", "title": "Consider supply-chain security per SLSA", "description": "Build provenance + supply-chain security gaps; SLSA framework would formalize improvements.", "remediation": "Adopt SLSA Level 2 minimum for production builds.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "nist_csf", "nis2"]},

    {"id": "F-VM-001", "theme": "vulnerability_mgmt", "severity": "critical", "title": "Critical vulnerabilities past patch SLA", "description": "5 critical-severity CVEs in production older than 30-day patch SLA; one is actively exploited in wild.", "remediation": "Patch immediately; document compensating controls if patching not possible; investigate any compromise indicators.", "remediation_days": 14, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "nis2", "hipaa"]},
    {"id": "F-VM-002", "theme": "vulnerability_mgmt", "severity": "major", "title": "Vulnerability scanning not running weekly", "description": "Scanning configured but execution stopped in past quarter due to tool change. 90+ day blind spot.", "remediation": "Resume scanning; investigate vulnerabilities discovered post-resume.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "nis2", "hipaa"]},
    {"id": "F-VM-003", "theme": "vulnerability_mgmt", "severity": "major", "title": "Patch SLAs not defined by severity", "description": "Patch SLA defined for 'all CVEs within 90 days'; not differentiated by severity. Critical vulns should be < 30 days.", "remediation": "Define severity-tiered SLAs; communicate; track compliance.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa", "nis2"]},
    {"id": "F-VM-004", "theme": "vulnerability_mgmt", "severity": "minor", "title": "Vulnerability exceptions lack expiry", "description": "Exception tracking exists but exceptions have no expiry; some are 18+ months old without re-evaluation.", "remediation": "Add expiry; re-evaluate all open exceptions.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-VM-005", "theme": "vulnerability_mgmt", "severity": "observation", "title": "Consider container image base auditing", "description": "Vulnerability scanning catches runtime; auditing base images at build time would prevent vulnerabilities reaching production.", "remediation": "Add build-time scanning + base-image inventory.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "nist_csf"]},

    {"id": "F-PS-001", "theme": "physical_security", "severity": "major", "title": "Server room access log incomplete", "description": "Server room access log shows entries but lacks visitor escort records for 4 of 12 sampled entries.", "remediation": "Reinforce escort policy; train + supervise; verify in next quarter.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "iso_13485", "hipaa"]},
    {"id": "F-PS-002", "theme": "physical_security", "severity": "major", "title": "Workstation security policy not enforced", "description": "Workstation locking policy documented but not enforced; observed several unattended unlocked workstations during walkthrough.", "remediation": "Configure auto-lock at 5 min; train staff; verify.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "hipaa", "soc_2"]},
    {"id": "F-PS-003", "theme": "physical_security", "severity": "minor", "title": "Visitor sign-in process bypassed", "description": "Visitor sign-in book exists but bypassed for 'known' visitors; 8 sampled visits lack sign-in evidence.", "remediation": "Reinforce policy + signage; consider electronic visitor management.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_13485", "hipaa"]},
    {"id": "F-PS-004", "theme": "physical_security", "severity": "observation", "title": "Consider biometric access for sensitive zones", "description": "Current access is card-based; biometric for sensitive zones (server rooms, R&D labs) would strengthen access discipline.", "remediation": "Evaluate biometric tooling; pilot.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "hipaa", "iso_13485"]},

    {"id": "F-DP-001", "theme": "data_protection_privacy", "severity": "critical", "title": "Right to erasure not honored within SLA", "description": "Erasure request from 60 days ago not fully completed; data persists in 3 systems including backups. GDPR Article 17 + 12(3) breached.", "remediation": "Complete erasure; identify all systems; commit to per-system erasure workflow.", "remediation_days": 14, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DP-002", "theme": "data_protection_privacy", "severity": "critical", "title": "International transfer without SCCs", "description": "Personal data transferred to US subprocessor; no adequacy decision relied on, no SCCs signed, no derogation applies. Schrems II requirement breached.", "remediation": "Execute SCCs (Commission 2021/914); conduct TIA per EDPB Rec. 01/2020; supplementary measures where needed.", "remediation_days": 30, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DP-003", "theme": "data_protection_privacy", "severity": "major", "title": "Privacy notice missing Article 13/14 elements", "description": "Privacy notice published but lacks retention periods + data subject rights detail per Article 13(2).", "remediation": "Update notice; publish version; track versions for evidence trail.", "remediation_days": 30, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DP-004", "theme": "data_protection_privacy", "severity": "major", "title": "Cookie banner pre-ticks consent", "description": "Cookie banner pre-ticks non-essential cookies; valid consent per GDPR Article 7 + EDPB guidance requires affirmative action.", "remediation": "Redesign banner; default to no consent for non-essential; document A/B test.", "remediation_days": 30, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DP-005", "theme": "data_protection_privacy", "severity": "major", "title": "DPO appointment not formal", "description": "DPO exists but appointment letter not signed by senior management per GDPR Article 37 + 38. Reporting line ambiguous.", "remediation": "Formal appointment letter; clarify reporting line to highest management; publish contact.", "remediation_days": 30, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DP-006", "theme": "data_protection_privacy", "severity": "minor", "title": "DSAR identity verification process inconsistent", "description": "DSAR identity verification varies across teams; one DSAR processed without proper identity check.", "remediation": "Standardize verification procedure; train DPO + intake team.", "remediation_days": 60, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DP-007", "theme": "data_protection_privacy", "severity": "observation", "title": "Consider privacy-enhancing technologies (PETs)", "description": "Current privacy posture is procedural; PETs (differential privacy, federated learning, secure enclaves) for high-risk processing would reduce exposure.", "remediation": "Pilot PET for one high-risk processing.", "remediation_days": 365, "applicable_frameworks": ["gdpr", "iso_42001"]},

    {"id": "F-MR-001", "theme": "management_review", "severity": "critical", "title": "Management review not performed in 18 months", "description": "Management review last documented 18 months ago. Clause 9.3 expects at planned intervals (annual minimum). System effectiveness not formally evaluated.", "remediation": "Schedule + conduct review; document inputs + outputs; calendar future reviews.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_13485", "soc_2"]},
    {"id": "F-MR-002", "theme": "management_review", "severity": "major", "title": "Management review missing AI-specific inputs", "description": "Management review covers ISMS but not AIMS-specific inputs (drift events, incidents, risk-register changes per ISO 42001 Clause 9.3).", "remediation": "Update review template for AIMS inputs; include in next review.", "remediation_days": 60, "applicable_frameworks": ["iso_42001"]},
    {"id": "F-MR-003", "theme": "management_review", "severity": "major", "title": "Open action items past due", "description": "Management review action items: 4 of 9 past due > 60 days. Tracking not actively managed.", "remediation": "Reassign owners; escalate stuck items; re-baseline due dates.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_13485", "soc_2"]},
    {"id": "F-MR-004", "theme": "management_review", "severity": "minor", "title": "Review attendance lacks senior leadership", "description": "Review held but CEO + CTO absent; attendance of senior leadership expected per Clause 5.1 + 9.3.", "remediation": "Schedule with leadership in advance; share inputs ahead of meeting.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_13485", "soc_2"]},

    {"id": "F-IA-001", "theme": "internal_audit", "severity": "critical", "title": "No internal audit programme", "description": "Clause 9.2 internal audit programme not documented; audits happen ad-hoc; no rolling 3-year coverage plan.", "remediation": "Design programme; assign auditors; schedule next 12 months minimum.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_13485", "soc_2", "hipaa"]},
    {"id": "F-IA-002", "theme": "internal_audit", "severity": "major", "title": "Auditors audit own work", "description": "Internal auditor for Clause 8.3 audit also owns the lifecycle process being audited. Independence breached.", "remediation": "Reassign auditor; document independence verification per assignment.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_13485"]},
    {"id": "F-IA-003", "theme": "internal_audit", "severity": "major", "title": "Audit findings not tracked to closure", "description": "Audit findings logged but closure verification not consistently performed. 12 findings show 'closed' without evidence of effectiveness.", "remediation": "Verify closure; require evidence; reopen unverified.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "soc_2"]},
    {"id": "F-IA-004", "theme": "internal_audit", "severity": "minor", "title": "Audit programme doesn't cover all clauses", "description": "Audit programme covers Clauses 4-7 but not 8-10 in current 3-year cycle.", "remediation": "Update programme; add missing clauses to remaining cycle.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_13485"]},

    {"id": "F-CI-001", "theme": "continual_improvement", "severity": "major", "title": "CAPA without effectiveness verification", "description": "Corrective action plans documented + closed but effectiveness verification missing for 6 of 10 sampled CAPAs.", "remediation": "Add measurable effectiveness verification to template; verify per CAPA; sample-check.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_13485", "fda_qsr"]},
    {"id": "F-CI-002", "theme": "continual_improvement", "severity": "major", "title": "Root cause analysis shallow", "description": "Root cause analysis on CAPAs documented but stops at proximate cause (e.g., 'engineer made mistake'); 5 Whys not applied.", "remediation": "Train CAPA owners on RCA methodology; re-do RCA on recent CAPAs.", "remediation_days": 90, "applicable_frameworks": ["iso_13485", "iso_42001", "iso_27001", "fda_qsr"]},
    {"id": "F-CI-003", "theme": "continual_improvement", "severity": "minor", "title": "Trend analysis not performed", "description": "Individual CAPAs handled but trend analysis across CAPAs not performed; missed systemic issues.", "remediation": "Quarterly trend analysis; pattern identification; address systemic causes.", "remediation_days": 90, "applicable_frameworks": ["iso_13485", "iso_27001", "iso_42001", "fda_qsr"]},
    {"id": "F-CI-004", "theme": "continual_improvement", "severity": "observation", "title": "Consider integrating CAPA into existing ticketing", "description": "CAPA tracking in separate tool from incident tickets; integration would reduce overhead.", "remediation": "Evaluate ticket-system extensions; pilot.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2"]},

    {"id": "F-DC-001", "theme": "documentation_control", "severity": "major", "title": "Obsolete documents accessible", "description": "Old versions of policies and procedures accessible in shared drives without 'obsolete' marking; risk of using superseded content.", "remediation": "Archive obsolete versions; reorganize document drive; reinforce procedure.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_13485", "iso_42001", "fda_qsr"]},
    {"id": "F-DC-002", "theme": "documentation_control", "severity": "major", "title": "Document approval workflow bypassed", "description": "Document approval workflow exists but 3 recent policy updates published without documented approval.", "remediation": "Enforce workflow at publication; train owners; audit recent publications.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "iso_13485", "iso_42001", "soc_2"]},
    {"id": "F-DC-003", "theme": "documentation_control", "severity": "minor", "title": "Document review cadence not enforced", "description": "Annual review cadence stated but 25% of controlled documents past due > 90 days.", "remediation": "Calendar reviews; track due dates; remind owners.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "iso_13485", "iso_42001"]},

    {"id": "F-AIMS-001", "theme": "aims_specific", "severity": "critical", "title": "AI policy missing required commitments", "description": "AI policy commits to lawful use only; missing beneficial purpose, human oversight, and continual improvement. ISO 42001 Clause 5.2 + Annex A.2.2 not satisfied.", "remediation": "Rewrite policy with all 4 commitments; board signoff; publish.", "remediation_days": 60, "applicable_frameworks": ["iso_42001"]},
    {"id": "F-AIMS-002", "theme": "aims_specific", "severity": "critical", "title": "AIMS scope omits third-party AI", "description": "AIMS scope statement (Clause 4.3) lists company-built AI systems but omits AI features in SaaS vendors used internally. Scope incomplete.", "remediation": "Update scope; inventory third-party AI; include in AIMS controls.", "remediation_days": 60, "applicable_frameworks": ["iso_42001"]},
    {"id": "F-AIMS-003", "theme": "aims_specific", "severity": "critical", "title": "AI system lifecycle skips decommission", "description": "AI lifecycle procedure (A.6) covers design through deployment + operation but lacks decommission phase. ISO 42001 expects full lifecycle.", "remediation": "Define decommission procedure; train owners; document.", "remediation_days": 60, "applicable_frameworks": ["iso_42001"]},
    {"id": "F-AIMS-004", "theme": "aims_specific", "severity": "major", "title": "V&V procedure for AI systems undefined", "description": "Annex A.6.2.4 verification + validation procedure not documented; tests exist but acceptance criteria not formalized.", "remediation": "Define V&V procedure; document acceptance criteria per system class; train.", "remediation_days": 90, "applicable_frameworks": ["iso_42001"]},
    {"id": "F-AIMS-005", "theme": "aims_specific", "severity": "major", "title": "Impact assessment signed by wrong authority", "description": "AI impact assessments for high-impact systems signed by tech lead; management approval expected per A.5.4.", "remediation": "Define signoff authority by impact tier; re-route assessments; backfill where needed.", "remediation_days": 60, "applicable_frameworks": ["iso_42001"]},

    {"id": "F-AIA-001", "theme": "ai_act_specific", "severity": "critical", "title": "Article 5 prohibited practice in production", "description": "AI system performs emotion recognition in workplace setting; Article 5(1)(f) prohibition applies. System cannot remain on EU market.", "remediation": "Disable in EU immediately; evaluate redesign for permitted use cases; document.", "remediation_days": 7, "applicable_frameworks": ["eu_ai_act"]},
    {"id": "F-AIA-002", "theme": "ai_act_specific", "severity": "critical", "title": "High-risk AI without conformity assessment", "description": "Annex III high-risk AI system on EU market; no Article 43 conformity assessment performed before placement.", "remediation": "Withdraw from market until conformity assessment complete; document Annex IV; CE marking.", "remediation_days": 30, "applicable_frameworks": ["eu_ai_act"]},
    {"id": "F-AIA-003", "theme": "ai_act_specific", "severity": "major", "title": "Non-EU provider without authorized representative", "description": "Non-EU provider placing AI system on EU market without appointed authorized representative per Article 22.", "remediation": "Appoint EU-established authorized representative; document mandate.", "remediation_days": 60, "applicable_frameworks": ["eu_ai_act"]},
    {"id": "F-AIA-004", "theme": "ai_act_specific", "severity": "major", "title": "Article 50 transparency not implemented", "description": "Customer-facing chatbot does not disclose AI interaction per Article 50(1).", "remediation": "Add disclosure to UX; A/B test wording.", "remediation_days": 30, "applicable_frameworks": ["eu_ai_act"]},
    {"id": "F-AIA-005", "theme": "ai_act_specific", "severity": "major", "title": "GPAI without Article 53 technical documentation", "description": "GPAI model provided to downstream integrators; Annex XI technical documentation not maintained.", "remediation": "Develop documentation per Annex XI; publish training-data summary; copyright policy.", "remediation_days": 60, "applicable_frameworks": ["eu_ai_act"]},

    {"id": "F-13485-001", "theme": "qms_specific", "severity": "critical", "title": "DHF incomplete for commercial device", "description": "Design history file for commercially distributed device lacks design validation evidence per ISO 13485 Clause 7.3.7.", "remediation": "Compile validation evidence; document; if not feasible, withdraw + revalidate.", "remediation_days": 60, "applicable_frameworks": ["iso_13485", "fda_qsr"]},
    {"id": "F-13485-002", "theme": "qms_specific", "severity": "critical", "title": "Process validation stale", "description": "Sterilization process not revalidated for 7 years despite supplier changes. ISO 13485 Clause 7.5.6 expects periodic revalidation.", "remediation": "Revalidate; document; calendar future revalidation.", "remediation_days": 90, "applicable_frameworks": ["iso_13485", "fda_qsr"]},
    {"id": "F-13485-003", "theme": "qms_specific", "severity": "major", "title": "Risk management file frozen at release", "description": "ISO 14971 risk management file not updated post-launch; post-production information feedback not occurring.", "remediation": "Update RMF with post-production information; commit to periodic review.", "remediation_days": 90, "applicable_frameworks": ["iso_13485", "iso_14971", "eu_mdr_745", "fda_qsr"]},
    {"id": "F-13485-004", "theme": "qms_specific", "severity": "major", "title": "PMCF plan exists but not executed", "description": "Post-market clinical follow-up plan documented per EU MDR Annex XIV Part B; execution data lacking after 12 months.", "remediation": "Execute per plan; document; report to notified body if outside plan.", "remediation_days": 90, "applicable_frameworks": ["iso_13485", "eu_mdr_745"]},

    {"id": "F-FDA-001", "theme": "fda_specific", "severity": "critical", "title": "MDR-reportable event not reported", "description": "Serious adverse event reportable per 21 CFR 803.50 not reported within 30 days. FDA enforcement exposure.", "remediation": "File MDR immediately with delay rationale; review complaint trending; CAPA.", "remediation_days": 7, "applicable_frameworks": ["fda_qsr"]},
    {"id": "F-FDA-002", "theme": "fda_specific", "severity": "major", "title": "Complaint files incomplete", "description": "Complaint log per 21 CFR 820.198 missing investigation closure for 8 of 30 sampled complaints.", "remediation": "Investigate + close; train complaint handlers.", "remediation_days": 60, "applicable_frameworks": ["fda_qsr"]},
    {"id": "F-FDA-003", "theme": "fda_specific", "severity": "major", "title": "Form 483 open observations past response window", "description": "Form 483 received 6 months ago; 2 of 5 observations lack documented response within 15-working-day window.", "remediation": "Respond immediately; document corrective action; escalate to legal counsel.", "remediation_days": 14, "applicable_frameworks": ["fda_qsr"]},
    {"id": "F-FDA-004", "theme": "fda_specific", "severity": "minor", "title": "Labeling review evidence gaps", "description": "Labeling per 21 CFR 801 reviewed at launch but no documented re-review for label changes in past 18 months.", "remediation": "Audit labels; document review per change.", "remediation_days": 60, "applicable_frameworks": ["fda_qsr"]},

    {"id": "F-HIPAA-001", "theme": "hipaa_specific", "severity": "critical", "title": "PHI breach not assessed under Breach Notification Rule", "description": "PHI exposure event 4 months ago; risk-of-compromise assessment per §164.402 not documented. Breach notification potentially required + missed.", "remediation": "Conduct retroactive assessment; if breach, notify per §164.404 + §164.406; document.", "remediation_days": 14, "applicable_frameworks": ["hipaa"]},
    {"id": "F-HIPAA-002", "theme": "hipaa_specific", "severity": "critical", "title": "Security Risk Analysis not performed", "description": "HIPAA Security Rule §164.308(a)(1)(ii)(A) risk analysis not documented in past 24 months despite material system changes.", "remediation": "Conduct + document analysis; address top risks; calendar annual review.", "remediation_days": 60, "applicable_frameworks": ["hipaa"]},
    {"id": "F-HIPAA-003", "theme": "hipaa_specific", "severity": "major", "title": "Encryption addressable spec not formally evaluated", "description": "HIPAA encryption is 'addressable'; organization not encrypting PHI at rest in one data store; no documented analysis of why.", "remediation": "Document analysis; if not encrypted, implement alternative protective measure or encrypt.", "remediation_days": 90, "applicable_frameworks": ["hipaa"]},
    {"id": "F-HIPAA-004", "theme": "hipaa_specific", "severity": "major", "title": "Workforce sanctions policy not enforced", "description": "§164.308(a)(1)(ii)(C) sanctions policy documented but no recorded sanctions despite repeat policy violations.", "remediation": "Apply sanctions per policy; document; refresh training.", "remediation_days": 60, "applicable_frameworks": ["hipaa"]},

    {"id": "F-NIS2-001", "theme": "nis2_specific", "severity": "critical", "title": "Incident notification 24h early warning missed", "description": "NIS2 Article 23 24-hour early warning to competent authority + CSIRT not provided after recent significant incident.", "remediation": "File retrospectively; document delay rationale; engage authority; update IR procedure.", "remediation_days": 7, "applicable_frameworks": ["nis2"]},
    {"id": "F-NIS2-002", "theme": "nis2_specific", "severity": "critical", "title": "Management body not approving cybersecurity measures", "description": "NIS2 Article 20 requires management bodies to approve cybersecurity risk-management measures + oversee implementation. Approval missing from board minutes.", "remediation": "Add to board agenda; document approval; ongoing oversight cadence.", "remediation_days": 60, "applicable_frameworks": ["nis2"]},
    {"id": "F-NIS2-003", "theme": "nis2_specific", "severity": "major", "title": "10 minimum cybersecurity measures incomplete", "description": "NIS2 Article 21(2)(a)-(j) 10 minimum measures: 2 not documented (policies on cryptography, basic cyber hygiene).", "remediation": "Document missing policies; verify implementation; submit registration update.", "remediation_days": 90, "applicable_frameworks": ["nis2"]},

    {"id": "F-CSF-001", "theme": "csf_specific", "severity": "major", "title": "NIST CSF profile not defined", "description": "Organization adopts NIST CSF 2.0 conceptually but no documented profile (current + target state) per CSF practice.", "remediation": "Develop profile; identify gaps; roadmap.", "remediation_days": 90, "applicable_frameworks": ["nist_csf"]},
    {"id": "F-CSF-002", "theme": "csf_specific", "severity": "minor", "title": "Recover function under-developed", "description": "CSF GOVERN + IDENTIFY + PROTECT + DETECT + RESPOND well-developed; RECOVER function lacks documented recovery planning.", "remediation": "Develop recovery planning + communications procedures.", "remediation_days": 90, "applicable_frameworks": ["nist_csf", "iso_27001"]},

    {"id": "F-AC-011", "theme": "access_control", "severity": "major", "title": "Service accounts without rotation", "description": "Service-account credentials shared across systems; no rotation in past 24 months.", "remediation": "Rotate; introduce secrets-management tooling; document.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa", "nis2"]},
    {"id": "F-AC-012", "theme": "access_control", "severity": "major", "title": "Privileged access logs not reviewed", "description": "Privileged user activity logs collected but no periodic review for anomalous behavior.", "remediation": "Define review cadence; assign reviewer; SIEM alerts for high-risk patterns.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "nist_csf"]},
    {"id": "F-AC-013", "theme": "access_control", "severity": "minor", "title": "Break-glass account not monitored", "description": "Emergency break-glass account exists but its usage not monitored; could be used without trace.", "remediation": "Alert on break-glass usage; quarterly review.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa"]},

    {"id": "F-AI-006", "theme": "asset_inventory", "severity": "major", "title": "Personal device access not inventoried", "description": "BYOD devices accessing corporate data not in asset inventory; mobile device management (MDM) coverage incomplete.", "remediation": "Inventory BYOD; require MDM enrollment; document policy.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "nist_csf"]},
    {"id": "F-AI-007", "theme": "asset_inventory", "severity": "major", "title": "Shadow IT discovered during audit", "description": "5 SaaS tools in use by teams without procurement / security review; some handle personal data.", "remediation": "Bring shadow IT under management or sunset; revise procurement gate.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "gdpr", "hipaa", "nist_csf"]},
    {"id": "F-AI-008", "theme": "asset_inventory", "severity": "observation", "title": "Inventory not integrated with CMDB", "description": "Asset inventory in spreadsheet; lacks integration with operational CMDB. Drift inevitable.", "remediation": "Integrate via API or migrate to CMDB-as-source-of-truth.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-RM-010", "theme": "risk_management", "severity": "major", "title": "AI bias risk not formally identified", "description": "AI risk register lacks systematic identification of bias risks across protected demographic categories.", "remediation": "Apply ISO 23894 risk identification methodology; bias testing per category; document.", "remediation_days": 90, "applicable_frameworks": ["iso_42001", "eu_ai_act"]},
    {"id": "F-RM-011", "theme": "risk_management", "severity": "minor", "title": "Risk treatment costs not estimated", "description": "Risk treatment plans don't estimate implementation cost; cost/benefit analysis missing.", "remediation": "Add cost estimate field; quarterly review.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "iso_42001", "nist_csf"]},

    {"id": "F-SM-011", "theme": "supplier_management", "severity": "major", "title": "Critical vendor SOC 2 expired", "description": "Critical vendor's SOC 2 Type II report on file is 18 months old; current period not yet collected.", "remediation": "Request current report; if vendor delayed, document compensating evidence.", "remediation_days": 60, "applicable_frameworks": ["soc_2", "iso_27001"]},
    {"id": "F-SM-012", "theme": "supplier_management", "severity": "minor", "title": "Vendor contact lists stale", "description": "Vendor security contact information stale; recent contact attempts bounced.", "remediation": "Refresh contact lists; verify quarterly.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "gdpr"]},

    {"id": "F-IR-011", "theme": "incident_response", "severity": "major", "title": "Forensic data preservation not standard", "description": "Recent incidents lack forensic preservation of affected systems; impedes investigation.", "remediation": "Document forensic preservation procedure; train IR team.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "nist_csf"]},
    {"id": "F-IR-012", "theme": "incident_response", "severity": "minor", "title": "External communications template missing", "description": "External communications for incidents drafted ad-hoc; no pre-approved templates.", "remediation": "Develop templates; legal + comms review; approve.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "gdpr"]},

    {"id": "F-ML-008", "theme": "monitoring_logging", "severity": "major", "title": "Database query logging disabled", "description": "Production database query logging disabled for performance reasons; can't audit who queried what.", "remediation": "Enable query logging for sensitive tables; size storage; document trade-offs.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "gdpr", "nist_csf"]},
    {"id": "F-ML-009", "theme": "monitoring_logging", "severity": "minor", "title": "Log timestamps not in standard timezone", "description": "Logs across systems use mix of local timezones + UTC; correlation difficult.", "remediation": "Standardize on UTC; document; backfill where feasible.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-CM-006", "theme": "change_management", "severity": "minor", "title": "Configuration drift not detected", "description": "Production configuration drift from documented baseline; no detection mechanism.", "remediation": "Deploy infrastructure-as-code drift detection; alert on deviations.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},
    {"id": "F-CM-007", "theme": "change_management", "severity": "observation", "title": "Consider GitOps for change discipline", "description": "Some changes still applied imperatively; GitOps would enforce change-via-PR discipline.", "remediation": "Pilot GitOps for one infrastructure layer.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-BC-006", "theme": "business_continuity", "severity": "major", "title": "Single region deployment without DR plan", "description": "Production deployment in single AWS region; no documented multi-region or cross-region DR plan.", "remediation": "Define DR plan (cross-region replicas, runbooks); test.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "nis2"]},
    {"id": "F-BC-007", "theme": "business_continuity", "severity": "minor", "title": "Communications plan missing for major outage", "description": "BCP covers technical recovery but lacks customer + employee communication plan for major outage.", "remediation": "Develop communications plan; pre-approved templates; cascade.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "nis2"]},

    {"id": "F-CT-006", "theme": "competence_training", "severity": "minor", "title": "Onboarding security training not within 30 days", "description": "Some new hires complete security training 60+ days after start; expected within 30 days.", "remediation": "Calendar reminders; manager accountability; track completion timeline.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "hipaa", "nist_csf"]},
    {"id": "F-CT-007", "theme": "competence_training", "severity": "observation", "title": "Phishing simulation results trending up", "description": "Phishing simulation click-rate increasing; training content may not be effective.", "remediation": "Refresh training content; targeted training for repeat clickers.", "remediation_days": 120, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "nis2", "hipaa"]},

    {"id": "F-DG-008", "theme": "data_governance", "severity": "major", "title": "Data classification policy applied unevenly", "description": "Data classification policy applied to engineering data stores but not marketing tools containing customer data.", "remediation": "Extend classification; train marketing.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "soc_2", "gdpr", "hipaa"]},
    {"id": "F-DG-009", "theme": "data_governance", "severity": "minor", "title": "Pseudonymization not consistently applied", "description": "Pseudonymization documented for some pipelines; not consistently applied to analytics datasets containing personal data.", "remediation": "Audit analytics datasets; pseudonymize where lawful basis is analytics.", "remediation_days": 90, "applicable_frameworks": ["gdpr", "iso_42001"]},

    {"id": "F-CR-006", "theme": "cryptography", "severity": "major", "title": "Keys stored alongside data", "description": "Encryption keys stored in same cloud account / region as encrypted data; compromise of one yields the other.", "remediation": "Move keys to dedicated KMS account; restrict access.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa"]},
    {"id": "F-CR-007", "theme": "cryptography", "severity": "minor", "title": "Certificate expiration monitoring incomplete", "description": "Certificate expiration alerts configured for some endpoints; internal certificates lack monitoring.", "remediation": "Extend monitoring; centralize certificate inventory.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-SD-006", "theme": "secure_sdlc", "severity": "major", "title": "Secrets in source control", "description": "Code review uncovered API keys + DB credentials committed to git history.", "remediation": "Rotate exposed secrets; remove from history; install pre-commit hooks; train.", "remediation_days": 30, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa"]},
    {"id": "F-SD-007", "theme": "secure_sdlc", "severity": "minor", "title": "Pull-request templates lack security checklist", "description": "PR templates exist but don't prompt security considerations (auth, input validation, secrets).", "remediation": "Add security checklist to template; train.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf"]},

    {"id": "F-VM-006", "theme": "vulnerability_mgmt", "severity": "major", "title": "Penetration test recommendations untracked", "description": "Annual penetration test completed; 12 findings; tracking + closure of remediation not centralized.", "remediation": "Centralize tracking; assign owners; verify closure.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "soc_2", "nist_csf", "hipaa"]},
    {"id": "F-VM-007", "theme": "vulnerability_mgmt", "severity": "observation", "title": "Consider bug bounty programme", "description": "External vulnerability discovery limited to annual pentest; bug bounty would broaden coverage.", "remediation": "Evaluate bug bounty platforms; pilot.", "remediation_days": 180, "applicable_frameworks": ["iso_27001", "nist_csf"]},

    {"id": "F-PS-005", "theme": "physical_security", "severity": "minor", "title": "Clean desk policy not enforced", "description": "Clean desk policy documented but walkthrough found sensitive printouts on unattended desks.", "remediation": "Reinforce policy; periodic walkthroughs; train.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "hipaa"]},
    {"id": "F-PS-006", "theme": "physical_security", "severity": "observation", "title": "Hardware disposal evidence incomplete", "description": "Hardware disposal documented for laptops; lacks evidence of certified destruction for storage media.", "remediation": "Use certified destruction service; collect certificates.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "hipaa", "nist_csf"]},

    {"id": "F-DP-008", "theme": "data_protection_privacy", "severity": "major", "title": "DSAR response > 30 days", "description": "12 of 50 DSARs in past quarter responded after Article 12(3) 1-month SLA; no extension communicated.", "remediation": "Investigate process bottlenecks; resource appropriately; communicate extensions where needed.", "remediation_days": 60, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DP-009", "theme": "data_protection_privacy", "severity": "minor", "title": "Privacy notice version history missing", "description": "Privacy notice updated multiple times; no version archive; cannot demonstrate which notice was active when.", "remediation": "Archive past versions with date stamps.", "remediation_days": 60, "applicable_frameworks": ["gdpr"]},
    {"id": "F-DP-010", "theme": "data_protection_privacy", "severity": "minor", "title": "Article 22 automated decisions not flagged", "description": "Automated decision-making (Article 22) used in credit decisions; data subjects not informed; human review not offered.", "remediation": "Add transparency; offer human review; document procedure.", "remediation_days": 60, "applicable_frameworks": ["gdpr", "eu_ai_act"]},

    {"id": "F-DC-004", "theme": "documentation_control", "severity": "observation", "title": "Consider read-only published documents", "description": "Controlled documents stored as editable Google Docs; risk of unauthorized edit. Read-only PDF publishing would be stronger control.", "remediation": "Publish read-only PDFs; restrict editing to authors.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "iso_13485", "iso_42001"]},

    {"id": "F-IA-005", "theme": "internal_audit", "severity": "minor", "title": "Audit reports lack standard format", "description": "Audit reports vary in format across auditors; difficult to compare or trend.", "remediation": "Define standard report template.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "soc_2", "iso_13485"]},

    {"id": "F-AIMS-006", "theme": "aims_specific", "severity": "major", "title": "AI model card missing", "description": "Production AI system lacks model card per Annex A.6.2.7. Documentation per Mitchell et al. (2019) pattern not produced.", "remediation": "Develop model card; publish internally; commit to update with retraining.", "remediation_days": 60, "applicable_frameworks": ["iso_42001"]},
    {"id": "F-AIMS-007", "theme": "aims_specific", "severity": "minor", "title": "Datasheet for datasets not produced", "description": "Training datasets lack datasheet per Gebru et al. (2021) pattern; not satisfying Annex A.7.4 fully.", "remediation": "Develop datasheets per dataset; document provenance + composition + intended use.", "remediation_days": 90, "applicable_frameworks": ["iso_42001"]},

    {"id": "F-AIA-006", "theme": "ai_act_specific", "severity": "major", "title": "Article 27 FRIA missing for public-sector deployer", "description": "Public-sector body deploying high-risk AI; Fundamental Rights Impact Assessment per Article 27 not performed.", "remediation": "Conduct FRIA; document; consult DPA where required.", "remediation_days": 60, "applicable_frameworks": ["eu_ai_act"]},
    {"id": "F-AIA-007", "theme": "ai_act_specific", "severity": "minor", "title": "EU database registration pending", "description": "High-risk Annex III system not yet registered in EU database per Article 71.", "remediation": "Register; document.", "remediation_days": 30, "applicable_frameworks": ["eu_ai_act"]},
    {"id": "F-AIA-008", "theme": "ai_act_specific", "severity": "critical", "title": "Substantial modification turns deployer into provider", "description": "Deployer substantially modified high-risk AI system; now operates as provider per Article 25(1) but did not assume provider obligations.", "remediation": "Document role change; assume provider obligations; conformity assessment.", "remediation_days": 30, "applicable_frameworks": ["eu_ai_act"]},

    {"id": "F-13485-005", "theme": "qms_specific", "severity": "major", "title": "Design transfer evidence missing", "description": "Design transfer per Clause 7.3.8 not formally documented for recent product. Manufacturing operates with insufficient design records.", "remediation": "Compile transfer evidence; document training; verify capability.", "remediation_days": 60, "applicable_frameworks": ["iso_13485", "fda_qsr"]},
    {"id": "F-13485-006", "theme": "qms_specific", "severity": "observation", "title": "Consider digital quality management system", "description": "QMS run on shared drives; eQMS would improve traceability + audit-readiness.", "remediation": "Evaluate eQMS vendors; pilot.", "remediation_days": 180, "applicable_frameworks": ["iso_13485", "fda_qsr"]},

    {"id": "F-FDA-005", "theme": "fda_specific", "severity": "major", "title": "UDI compliance gaps", "description": "Some devices commercially distributed lack UDI labeling per 21 CFR 830.", "remediation": "Audit + label; submit to GUDID; document.", "remediation_days": 90, "applicable_frameworks": ["fda_qsr"]},
    {"id": "F-FDA-006", "theme": "fda_specific", "severity": "observation", "title": "Pre-submission strategy could leverage Q-sub", "description": "Product strategy proceeds toward 510(k) without leveraging FDA Q-Submission programme.", "remediation": "Consider Q-sub for novel aspects.", "remediation_days": 180, "applicable_frameworks": ["fda_qsr"]},

    {"id": "F-HIPAA-005", "theme": "hipaa_specific", "severity": "major", "title": "Workforce member access not minimum-necessary", "description": "Workforce access provisioned at role level rather than minimum-necessary per §164.502(b). Some members access PHI beyond their need.", "remediation": "Audit + tighten access; document minimum-necessary determination.", "remediation_days": 90, "applicable_frameworks": ["hipaa"]},
    {"id": "F-HIPAA-006", "theme": "hipaa_specific", "severity": "minor", "title": "Notice of privacy practices outdated", "description": "Notice of privacy practices per §164.520 last updated 2 years ago; substantive policy changes not reflected.", "remediation": "Update notice; redistribute per requirement; document.", "remediation_days": 60, "applicable_frameworks": ["hipaa"]},

    {"id": "F-NIS2-004", "theme": "nis2_specific", "severity": "major", "title": "Registration with competent authority pending", "description": "Organization meets NIS2 essential entity criteria but has not registered with national competent authority per Article 24.", "remediation": "Submit registration; document.", "remediation_days": 30, "applicable_frameworks": ["nis2"]},
    {"id": "F-NIS2-005", "theme": "nis2_specific", "severity": "minor", "title": "Supply-chain security measures not documented", "description": "NIS2 Article 21(2)(d) supply-chain security measures not separately documented from generic supplier-management.", "remediation": "Document NIS2-specific supply-chain measures.", "remediation_days": 60, "applicable_frameworks": ["nis2"]},

    {"id": "F-CSF-003", "theme": "csf_specific", "severity": "minor", "title": "CSF tiers not assigned", "description": "NIST CSF 2.0 implementation tiers (Partial / Risk Informed / Repeatable / Adaptive) not assigned per function.", "remediation": "Self-assess tiers; document; target tier.", "remediation_days": 90, "applicable_frameworks": ["nist_csf"]},

    {"id": "F-MDR-001", "theme": "mdr_specific", "severity": "critical", "title": "EU MDR technical documentation gap", "description": "Technical documentation per Annex II/III lacks recent clinical-evaluation update; notified body audit imminent.", "remediation": "Update documentation immediately; engage notified body.", "remediation_days": 30, "applicable_frameworks": ["eu_mdr_745"]},
    {"id": "F-MDR-002", "theme": "mdr_specific", "severity": "major", "title": "Person Responsible for Regulatory Compliance not appointed", "description": "EU MDR Article 15 PRRC role not formally appointed for the EU operations.", "remediation": "Appoint PRRC meeting Article 15(1)-(2) qualifications; document.", "remediation_days": 30, "applicable_frameworks": ["eu_mdr_745"]},
    {"id": "F-MDR-003", "theme": "mdr_specific", "severity": "minor", "title": "PMCF reports lag schedule", "description": "Post-Market Clinical Follow-up reports not produced per agreed schedule.", "remediation": "Catch up; rebaseline schedule.", "remediation_days": 90, "applicable_frameworks": ["eu_mdr_745"]},

    {"id": "F-14971-001", "theme": "risk_management_medical", "severity": "major", "title": "Risk management plan not updated for software change", "description": "ISO 14971 risk management plan + risk file not updated after material software change.", "remediation": "Update RMF; re-evaluate risks; document.", "remediation_days": 60, "applicable_frameworks": ["iso_14971", "iso_13485", "eu_mdr_745"]},
    {"id": "F-14971-002", "theme": "risk_management_medical", "severity": "minor", "title": "Residual risk evaluation lacks acceptability criteria", "description": "Residual risk evaluated but acceptability criteria per ISO 14971 §7 not formally established.", "remediation": "Define acceptability criteria; document.", "remediation_days": 90, "applicable_frameworks": ["iso_14971", "iso_13485"]},

    {"id": "F-MDR-004", "theme": "mdr_specific", "severity": "major", "title": "EUDAMED registration incomplete", "description": "EU MDR EUDAMED registration of device, manufacturer, or UDI elements incomplete despite mandatory data submission requirements.", "remediation": "Complete required EUDAMED modules; track future module activations.", "remediation_days": 60, "applicable_frameworks": ["eu_mdr_745"]},
    {"id": "F-MDR-005", "theme": "mdr_specific", "severity": "minor", "title": "Vigilance reporting log incomplete", "description": "EU MDR vigilance reporting log per Article 87 has 3 entries past 15-day reporting timeline.", "remediation": "Investigate root cause; tighten internal SLA; train.", "remediation_days": 60, "applicable_frameworks": ["eu_mdr_745"]},

    {"id": "F-14971-003", "theme": "risk_management_medical", "severity": "major", "title": "Production + post-production information feedback weak", "description": "ISO 14971 §9 requires production + post-production information be collected + analysed; current process only acts on customer complaints, missing field data + service trends.", "remediation": "Expand information sources; document process; integrate with PMS.", "remediation_days": 90, "applicable_frameworks": ["iso_14971", "iso_13485", "eu_mdr_745"]},

    {"id": "F-AIA-009", "theme": "ai_act_specific", "severity": "major", "title": "Deepfake content not marked AI-generated", "description": "Generative AI feature produces audio/video without machine-readable AI-generated marking per Article 50(2).", "remediation": "Implement watermarking; document.", "remediation_days": 60, "applicable_frameworks": ["eu_ai_act"]},
    {"id": "F-AIA-010", "theme": "ai_act_specific", "severity": "minor", "title": "Instructions for use missing operational risks section", "description": "Article 13 instructions for use provided to deployers but do not adequately describe foreseeable operational risks.", "remediation": "Update IFU with risks + mitigations; train downstream.", "remediation_days": 60, "applicable_frameworks": ["eu_ai_act"]},

    {"id": "F-FDA-007", "theme": "fda_specific", "severity": "major", "title": "Cybersecurity for connected device not addressed in 510(k)", "description": "Connected device 510(k) submission lacks cybersecurity content per FDA Cybersecurity Guidance (Sep 2023); FDA refused acceptance.", "remediation": "Develop cybersecurity content per guidance; resubmit.", "remediation_days": 90, "applicable_frameworks": ["fda_qsr"]},
    {"id": "F-FDA-008", "theme": "fda_specific", "severity": "minor", "title": "510(k) summary lacks comparative data", "description": "510(k) summary per 21 CFR 807.92 lacks substantive comparison to predicate device.", "remediation": "Add comparative data; resubmit if FDA requests.", "remediation_days": 60, "applicable_frameworks": ["fda_qsr"]},

    {"id": "F-HIPAA-007", "theme": "hipaa_specific", "severity": "minor", "title": "Workforce member termination workflow missing PHI access revocation", "description": "Termination workflow revokes general access but doesn't specifically address PHI access systems; 2 terminated members retained EHR access > 2 days.", "remediation": "Add PHI-specific revocation step; verify.", "remediation_days": 30, "applicable_frameworks": ["hipaa", "iso_27001"]},

    {"id": "F-MR-005", "theme": "management_review", "severity": "minor", "title": "Management review inputs not pre-distributed", "description": "Management review held but inputs distributed only at meeting; senior leadership cannot prepare in advance.", "remediation": "Pre-distribute inputs 1 week in advance.", "remediation_days": 60, "applicable_frameworks": ["iso_27001", "iso_42001", "iso_13485", "soc_2"]},

    {"id": "F-IA-006", "theme": "internal_audit", "severity": "observation", "title": "Audit programme could integrate cross-framework findings", "description": "Audits performed per framework but cross-framework finding impact not systematically tracked; missed reuse opportunity.", "remediation": "Use compliance-os cross_framework_mapper output to tag findings.", "remediation_days": 90, "applicable_frameworks": ["iso_27001", "iso_42001", "soc_2", "iso_13485"]}
  ]
}
