RUNTIME AI SECURITY FOR PHARMACEUTICAL & LIFE SCIENCES

52 modules. 8 security layers. One command to deploy.

MERCK NOTPETYA: $1.4B DAMAGES, MANUFACTURING HALTED · CENCORA BREACH: 27 PHARMA COMPANIES, $40M SETTLEMENT · MEGASYN: AI GENERATED 40,000 TOXIC MOLECULES IN 6 HOURS · FDA: 7-STEP CREDIBILITY ASSESSMENT FOR AI IN SUBMISSIONS · EU AI ACT: CLINICAL DECISION SUPPORT = HIGH-RISK (2 AUG 2026) · 68% OF PHARMA FIRMS DEPLOYING AI AGENTS IN DRUG DISCOVERY · MERCK NOTPETYA: $1.4B DAMAGES, MANUFACTURING HALTED · CENCORA BREACH: 27 PHARMA COMPANIES, $40M SETTLEMENT · MEGASYN: AI GENERATED 40,000 TOXIC MOLECULES IN 6 HOURS · FDA: 7-STEP CREDIBILITY ASSESSMENT FOR AI IN SUBMISSIONS · EU AI ACT: CLINICAL DECISION SUPPORT = HIGH-RISK (2 AUG 2026) · 68% OF PHARMA FIRMS DEPLOYING AI AGENTS IN DRUG DISCOVERY ·

Eight Security Layers

From GAMP 5 validation to clinical trial integrity — every AI agent in your pharmaceutical operation is classified, validated, and contained.

LAYER 2 // GxP VALIDATION & COMPLIANCE
ENFORCING

GxP Validation & Compliance

Module 100 classifies AI systems under GAMP 5 categories, enforces 21 CFR Part 11 electronic records, monitors ALCOA+ data integrity, and automates CSV documentation. Module 37 handles multi-framework compliance. Module 89 enforces behaviour policy.

Module 100Pharmaceutical AI Validation Engine
LAYER 3 // DRUG DISCOVERY INTEGRITY
MONITORING

Drug Discovery Integrity

Module 40 catches hallucinated molecular structures and fabricated trial data. Module 85 guards against goal drift in discovery AI. Module 42 secures RAG pipelines feeding pharmacological knowledge bases. Module 72 prevents context window poisoning of research agents.

6Discovery Integrity Modules
LAYER 4 // CLINICAL TRIAL SECURITY
PROTECTING

Clinical Trial Security

Module 61 monitors clinical AI decision-making for ICH E6(R3) compliance. Module 67 enforces human-in-the-loop for patient safety decisions. Module 53 enables rollback of AI actions affecting trial protocols. Module 46 secures voice-based clinical data capture.

4Clinical Security Modules
MODULE OVERVIEW
0
Modules Active
0
Specialist Modules
0
Security Layers
Module 100
Pharmaceutical AI Validation Engine
GAMP 5
Classifies AI systems under GAMP 5 categories (1–5 + AI/ML). Auto-generates validation strategies and documentation requirements
21 CFR PART 11
Enforces electronic signature requirements, access controls, and record integrity hashing for every AI-generated record
ALCOA+
Validates data integrity across all 8 criteria — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring
"A hallucinating AI in drug discovery is not a software bug. It is a patient safety event."

No vendor secures AI agents at runtime in pharmaceutical environments. Veeva, IQVIA, and Medidata manage data workflows. We secure the AI agents operating within them. Specter AI Pharma is the missing validation layer between autonomous AI and patient safety.

52
Modules protecting pharma AI
53
Docker containers deployed
7
Module 100 subsystems
88
Module 100 tests passing
8
Compliance frameworks covered

Is Your Pharma AI Validated?

Every AI agent managing your drug discovery, clinical trials, or manufacturing is a regulatory surface. The FDA is already asking questions. Specter AI Pharma makes your AI agents audit-ready.