Agent Governance for Pharmaceutical

For agent governance in pharmaceutical, the gap between dev-time tracing and production governance is where most teams get stuck.

The pharmaceutical challenge for agent governance

21 CFR Part 11 electronic records requirements and GxP validation overlay make audit evidence and change control essential.

For agent governance specifically, this means combining real-time runtime controls with evidence collection auditors and risk teams expect.

Regulatory backdrop

FDA 21 CFR Part 11
GxP
EU AI Act →
GDPR →
HIPAA →

Real agent use cases in pharmaceutical

Pharmacovigilance agent processing adverse event reports
Regulatory submission drafting agent
Medical affairs literature review agent
Clinical trial protocol drafting agent
Patient adherence outreach agent
Manufacturing deviation classification agent

How Prefactor delivers agent governance for pharmaceutical

Pre-deployment validation — eval suites per agent, datasets versioned with audit links, champion-challenger evaluation between versions.

Runtime enforcement — policy-as-code controls what agents can do, approval routing for high-impact actions, per-agent spend caps, kill switches.

Continuous monitoring — drift detection, per-agent quality scores, cost and latency monitoring, population stability tracking.

Audit and evidence — tamper-evident logs of every agent action with cryptographic hashing, auditor-ready exports, change management records, evidence of human oversight where required.

Implementation pattern

Week 1-2: Shadow deployment - non-production, real traffic, observe but don't enforce
Week 3-4: Pilot with one production agent - passive policy first, then blocking
Week 5-8: Production enforcement with approval flows integrated
Quarter 2+: Expand to additional agents on same governance model

FAQ

Can Prefactor run inside our environment / VPC? Yes. Enterprise customers run Prefactor self-hosted. Air-gapped deployments supported.

Do you have a vendor security questionnaire prepared? Yes. Standard questionnaires prefilled.

Can non-engineers (compliance, risk, MRM) use Prefactor? Yes. Separate role-based views for engineering, compliance, MRM, and audit.

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