Built for clinical, pharmacovigilance, MLR, and GMP quality workflows
Ship AI agentshealth authorities will trust.
KLA gives life sciences companies runtime governance infrastructure to deploy AI agents in clinical workflows with 21 CFR Part 11 audit trails, GxP policy controls, and EU AI Act evidence built in. Give R&D speed, and Quality Assurance proof.
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The continuous validation layer for life sciences AI.
In pharma, R&D pushes for speed-to-market while quality teams protect patient safety and data integrity. KLA sits in the execution path to continuously validate what agents do, route high-risk actions for human approval, and produce immutable evidence for inspections.
R&D and Digital Health Teams
KLA Digital - Continuous Validation Layer
Quality, Regulatory, and Safety
You can build agents faster than you can validate them.
AI model capability is no longer the bottleneck. Validation capacity is. Data science teams can prototype in weeks, but QA and regulatory teams need decision lineage, immutable logs, and inspection-ready evidence before deployment.
Regulators are watching
FDA, EMA, and MHRA expectations are tightening around AI in clinical workflows. Unverified LLM behavior can trigger FDA Form 483 observations, warning letters, and even clinical trial holds.
Validation can't keep pace
Data science teams prototype AI in weeks, but traditional Computer System Validation (CSV) takes months. Promising pilots stall in validation before they reach live operations.
Inspectors demand runtime proof
Inspectors do not only want SOPs. They expect ALCOA+ data integrity evidence showing exactly what literature was cited, who approved critical actions, and proof records are immutable.
From SOPs to inspection-ready evidence.
KLA runs as governance infrastructure in production, enforcing controls during agent execution and generating validation evidence by default.
Translate SOPs into enforceable checkpoints
Your 200-page Standard Operating Procedure (SOP) or Validation Plan becomes a structured, machine-readable policy pack that agents must satisfy at runtime.
Agents run with least-privilege tool access
Each agent receives only the systems and data access needed for its validated role. KLA blocks unauthorized actions in real time.
High-risk steps trigger human approval
When risk thresholds are crossed, execution pauses for designated reviewers in QA, safety, or regulatory with full context and source evidence.
Evidence Room export in one click
Every run produces a cryptographically verifiable evidence bundle with decision lineage, policy enforcement logs, approvals, and integrity manifests.
Deploy high-impact agents without compromising validation.
KLA unlocks autonomous workflows where ROI is high and regulatory friction is highest across clinical, safety, and quality operations.
Clinical Protocol Agent
Ingest past trial data and scientific literature to draft optimized 200-page clinical study protocols with faster first-pass quality.
KLA Unlock
Full decision lineage proving how inclusion and exclusion criteria were selected, with cryptographic evidence that no medical parameters were hallucinated.
Historical trial data, eligibility criteria, medical literature
Pharmacovigilance (PV) Agent
Ingest global adverse event reports, translate and MedDRA-code them, and prioritize severe cases in near real time.
KLA Unlock
Identity-bound maker-checker workflows where each automated triage decision includes exact source citations for EMA/FDA reporting timelines.
Adverse event narratives, MedDRA dictionaries, safety databases
MLR Review Copilot
Review promotional materials and sales aids against strict off-label promotion constraints before distribution.
KLA Unlock
Runtime policy firewall blocks non-compliant claims before publication while auto-generating review evidence for medical, legal, and regulatory sign-off.
Promotional claims, approved labeling, reviewer comments
GMP Manufacturing QA Agent
Monitor batch production records and cold-chain telemetry to detect deviations and quality anomalies early.
KLA Unlock
Cryptographically verified anomaly logs feed batch release decisions with tamper-evident evidence for QA review.
Batch records, sensor telemetry, deviation events
eCTD / Regulatory Dossier Agent
Auto-compile Clinical Study Reports (CSRs) and related submission artifacts for NDAs and BLAs with reduced assembly time.
KLA Unlock
Automated evidence assembly with traceable provenance links that simplify health-authority submission audits.
CSR drafts, study outputs, dossier templates
Every stakeholder gets what they need.
Life sciences buying decisions involve QA, regulatory, R&D, and scientific IT leaders. KLA creates concrete value for each function.
Patient safety controls at runtime
Policy checkpoints enforce validated behavior before high-risk actions execute, reducing clinical and quality exposure.
ALCOA+ evidence on demand
One-click Evidence Room exports show attributable, legible, contemporaneous, original, and accurate records with integrity proof.
Confident release decisions
Approve deployments with continuous validation evidence rather than static sign-off packets compiled after the fact.
What inspectors actually ask for.
The Evidence Room generates complete, cryptographically verifiable evidence bundles for every pharma AI workflow run.
What is in every Evidence Room export:
Technical Documentation
21 CFR Part 11 and Annex 11 package - 38 pages
Evidence Manifest
SHA-256 hash - Integrity verified
Policy Enforcement Log
24 checkpoints passed - 3 escalated
Human Oversight Records
3 approvals - Identity-bound
ALCOA+ Integrity Report
Source citations and tamper-evidence complete
SHA-256: e3b0c44298fc1c...a495991b7852b855 · Integrity verified
Map runtime controls to life sciences obligations.
KLA maps runtime agent governance to concrete requirements across global pharma and clinical frameworks.
FDA 21 CFR Part 11 and EU Annex 11
Requirements for electronic records, electronic signatures, and audit trail integrity in regulated systems.
GxP (GCP, GLP, GMP, GVP)
Controls ensuring AI agents operate within validated clinical, laboratory, manufacturing, and safety boundaries.
FDA / EMA / MHRA AI Expectations
Traceability, reproducibility, and human oversight evidence for AI used in regulated decision paths.
EU AI Act
Coverage for high-risk AI controls relevant to Software as a Medical Device and clinical decision support.
HIPAA and GDPR
Privacy, data minimization, and lawful processing safeguards for patient and trial participant data.
CSA and Validation Governance
Support modern Computer Software Assurance approaches with continuous runtime evidence and risk-based controls.
The validation control plane under the hood.
Each capability is designed for one outcome: making life sciences AI deployments provably safe, traceable, and inspection-ready.
Policy-as-Code Checkpoints
Transform SOPs and validation plans into version-controlled runtime rules that agents cannot bypass.
Human Gatekeepers
Pause high-risk actions for identity-bound reviewer approval with full context before execution continues.
Tamper-Evident Audit Trail
Append-only records with cryptographic verification prove prompts, sources, decisions, and approvals were not altered.
Continuous Monitoring
Detect drift, near misses, and control deviations in real time with configurable thresholds and escalations.
Evidence Room Exports
Export complete validation and inspection bundles with provenance, approvals, and integrity manifests in one click.
Win the internal governance review.
Give internal sponsors assets they can use in QA boards, validation councils, and regulatory planning meetings.
Executive Summary
One-page overview of KLA runtime governance for life sciences AI and validated deployment programs.
Download PDFControls Mapping
Mapping across 21 CFR Part 11, Annex 11, GxP domains, EU AI Act, HIPAA, and GDPR obligations.
Download PDFCSA Validation Memo
Ready-to-customize Computer Software Assurance memo template for approving a production AI agent.
Download TemplateSecurity Architecture
Technical whitepaper covering encryption, deployment models, data sovereignty, and scientific-system integration.
Download WhitepaperEvidence Room Sample
Complete sample evidence export from a pharmacovigilance triage run showing what inspectors receive.
Download SampleRegulatory Timeline
Key milestones and AI-governance expectations for health-authority engagement and rollout planning.
Download GuideBuilt for high-stakes regulated operations.
Life sciences teams need implementation partners that understand validation depth, quality systems, and audit realities.
Life sciences workflow fit
Designed for clinical, safety, and quality processes where patient outcomes and data integrity are non-negotiable.
Validation-first architecture
Continuous runtime controls align with QA and regulatory expectations from day one of deployment.
Cryptographic evidence at scale
Immutable audit logs and verifiable manifests provide defensible proof for every high-risk AI decision.
Turn AI from a validation bottleneck into a quality-approved asset.
Stop shelving high-impact pilots because validation evidence arrives too late. Prove one critical workflow in four weeks with measurable speed gains and inspection-ready evidence.
In your 30-minute briefing, we will:
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