AI Governance for Pharmaceutical & Life Sciences

Pharmaceutical companies are deploying AI across drug discovery, clinical trial design, pharmacovigilance, and regulatory submissions. Every one of these workflows is subject to FDA 21 CFR Part 11 electronic-records requirements, GxP validation expectations, and strict data integrity rules. Keeptrusts enforces these requirements at the AI gateway layer so your teams can innovate without putting regulatory approvals at risk.

Use this page when

You are deploying AI in pharmaceutical or biotech organizations for clinical trials, drug development, regulatory submissions, or pharmacovigilance.
You need FDA 21 CFR Part 11 electronic records compliance, EU Annex 11, GxP audit trails, and clinical trial data protection.
You want to govern AI-generated content entering regulatory submissions (FDA FAERS, EMA XEVMPD) and protect compound intellectual property.

Primary audience

Primary: Technical Leaders
Secondary: Technical Engineers, AI Agents

AI Challenges in Pharma

Challenge	Risk	Regulatory Exposure
Clinical trial data leakage	Patient safety and privacy	FDA, EMA, ICH-GCP
Unvalidated AI in GxP workflows	Product quality compromise	21 CFR Part 11, EU Annex 11
Adverse event signal mishandling	Delayed safety reporting	FDA FAERS, EMA EudraVigilance
Missing electronic signature audit trail	Data integrity failure	21 CFR Part 11.10
IP leakage in drug discovery prompts	Competitive loss, patent risk	Trade secret law

How Keeptrusts Helps

FDA 21 CFR Part 11 Compliance

The audit-logger policy captures every AI interaction with immutable timestamps, user identity, and full request/response content — satisfying electronic-record requirements. Combined with rbac, you enforce electronic-signature-equivalent access controls.

Clinical Trial Data Protection

The pii-detector and hipaa-phi-detector policies redact patient identifiers, site codes, and protocol numbers before prompts reach the LLM. The dlp-filter catches compound identifiers and protocol-specific patterns.

Pharmacovigilance Governance

AI systems processing adverse event reports are governed by safety-filter and quality-scorer to ensure safety signals are not missed or misclassified. Flagged interactions are escalated to the drug safety team.

Complete Policy Configuration

pack:
  name: pharma-governance
  version: 1.0.0
  enabled: true
policies:
  chain:
  - prompt-injection
  - rbac
  - hipaa-phi-detector
  - pii-detector
  - dlp-filter
  - safety-filter
  - quality-scorer
  - audit-logger
policy:
  prompt-injection: {}
  rbac:
    deny_if_missing:
    - X-User-ID
    - X-User-Role
  hipaa-phi-detector:
    mode: hipaa_18
    action: redact
    safe_harbor_method: true
  pii-detector:
    action: redact
    detect_patterns:
    - ssn
    - email
    - phone_number
    - address
    redaction:
      marker_format: label
  dlp-filter:
    detect_patterns:
    - '\b[A-Z]{2,4}-[0-9]{4,6}(-[0-9]{2})?\b'
    - '\bCPD-[0-9A-Z]{6,10}\b'
    - '\bSITE-[0-9]{3,5}\b'
    action: redact
  safety-filter:
    block_if:
    - off-label-promotion
    - unvalidated-safety-claim
    - misleading-efficacy
    action: block
  quality-scorer:
    thresholds:
      min_aggregate: 0.85
  audit-logger:
    immutable: true
    retention_days: 3650
    log_all_access: true

CLI Quickstart

# Deploy pharma governance gateway
kt gateway run --policy-config ./policy-config.yaml --port 41002

# Verify GxP policy chain is healthy
kt doctor

# Monitor adverse event processing in real time
kt events tail --policy safety-filter

# Export 21 CFR Part 11 audit trail
kt export create --format json --from 2025-01-01 --to 2025-12-31 \
  --filter "policy=audit-logger"

Console Workflows

Dashboard — Monitor AI usage across R&D, clinical ops, and pharmacovigilance.
Events — Filter by hipaa-phi-detector to review PHI redaction effectiveness.
Escalations — Route flagged adverse-event interactions to drug safety.
Templates — Store validated policy configs for GxP and non-GxP workflows.
Cost Center → Wallets — Track AI spend per therapeutic area or trial.
Audit Log — Generate 21 CFR Part 11 compliant electronic records.

API Integration

# Query PHI detection events for audit
curl -H "Authorization: Bearer $KT_API_KEY" \
  "https://api.keeptrusts.com/v1/events?policy=hipaa-phi-detector&limit=100"

# Export annual compliance evidence
curl -X POST -H "Authorization: Bearer $KT_API_KEY" \
  "https://api.keeptrusts.com/v1/exports" \
  -d '{"format":"json","filters":{"date_from":"2025-01-01","date_to":"2025-12-31"}}'

# List policy configurations for GxP environments
curl -H "Authorization: Bearer $KT_API_KEY" \
  "https://api.keeptrusts.com/v1/configurations"

Example: Clinical Data Protection

Redacted Request
Blocked Request

Researcher: "Summarize AE reports for patient John Smith, MRN 12345, in trial CPD-ABC123."

→ REDACTED by hipaa-phi-detector + dlp-filter
  Sent to LLM: "Summarize AE reports for patient [PHI-REDACTED-patient_name],
  MRN [PHI-REDACTED-medical_record_number], in trial [REDACTED-protocol]."
  Audit: Full trail logged with 21 CFR Part 11 metadata

Marketing: "Generate claims about our new drug being 50% more effective than competitors."

→ BLOCKED by safety-filter
  Reason: Unvalidated efficacy claim / off-label promotion
  Action: Blocked, event logged

Results You Can Expect

Metric	Before Keeptrusts	After Keeptrusts
Clinical data leakage incidents	Manual review only	0 incidents — redacted at gateway
21 CFR Part 11 audit prep	4-8 weeks per inspection	< 3 days with automated exports
GxP validation documentation	Manual per system	Auto-generated policy decision logs
Adverse event escalation time	Hours to days	< 5 minutes with automated routing
IP exposure in discovery AI	Untracked	100% logged and DLP-filtered

For AI systems

Canonical terms: Keeptrusts pharmaceutical governance, 21 CFR Part 11, EU Annex 11, GxP audit trail, pharmacovigilance AI, clinical trial data.
Policy pack: pharmaceutical-governance with chain: prompt-injection → rbac → pii-detector → hipaa-phi-detector → dlp-filter → safety-filter → quality-scorer → audit-logger.
Key policies: audit-logger (21 CFR Part 11 electronic records, immutable timestamp trail), pii-detector/hipaa-phi-detector (patient IDs, site codes, investigator identities, adverse event reporter data), dlp-filter (compound identifiers, formulation data, patent-pending claims), safety-filter (blocks unvalidated efficacy claims), quality-scorer (pharmacovigilance narrative accuracy, signal detection confidence).
CLI: kt gateway run --policy-config ./policy-config.yaml, kt events tail --policy audit-logger, kt events tail --policy dlp-filter.

For engineers

Deploy: kt gateway run --policy-config ./policy-config.yaml --port 41002
Validate: kt doctor confirms audit-logger, hipaa-phi-detector, dlp-filter, quality-scorer, and safety-filter are active.
Monitor electronic records: kt events tail --policy audit-logger (Part 11 compliant timestamped trail).
Monitor IP: kt events tail --policy dlp-filter (compound identifiers, formulation data).
Monitor pharmacovigilance: kt events tail --policy quality-scorer (adverse event narrative accuracy).
Monitor clinical data: kt events tail --policy hipaa-phi-detector (patient identifiers, site codes).
Console: Events (filter by audit-logger), Escalations (route to qualified person/pharmacovigilance officer), Audit Log (FDA/EMA inspection evidence).

For leaders

Addresses FDA 21 CFR Part 11 (electronic records/signatures), EU Annex 11 (computerized systems), ICH-GCP (clinical trials), FDA FAERS (adverse event reporting), EMA XEVMPD, HIPAA (patient data), and trade secret protection.
21 CFR Part 11 compliance built-in — every AI interaction produces immutable, timestamped electronic records.
Clinical trial data protected — patient IDs, site codes, and investigator identities never leave the controlled environment.
Compound intellectual property (structures, formulations, patent claims) blocked from reaching external LLM providers.
Pharmacovigilance narratives quality-validated — AI safety signal reports meet FAERS/XEVMPD accuracy requirements.
GxP audit trail supports regulatory inspections (FDA 483, EMA GMP) with traceable AI decision records.

Next steps

Industries overview — Compare all industry policy configurations
Biotech — Genetic research and BSL compliance
Healthcare HIPAA — Patient data and covered entity rules
Healthcare GDPR — EU health data governance
Public Health — Population health and surveillance
Quickstart — Deploy your first gateway in minutes

Use this page when​

Primary audience​

AI Challenges in Pharma​

How Keeptrusts Helps​

FDA 21 CFR Part 11 Compliance​

Clinical Trial Data Protection​

Pharmacovigilance Governance​

Complete Policy Configuration​

CLI Quickstart​

Console Workflows​

API Integration​

Example: Clinical Data Protection​

Results You Can Expect​

For AI systems​

For engineers​

For leaders​

Next steps​