Private agentic AI for regulated industries. Your tenant, your models, your perimeter.
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// Private agentic AI · For regulated industries
Software that does the work. Not just tracks it.
Agents that author, execute, and defend your validation, procurement, and tender work. Optimize efficiency, assure data integrity, and be audit-ready — with systems grounded in your SOPs, running inside your security envelope.
From intake to PO. Agents draft specifications, shortlist qualified suppliers, run compliant RFQs, and negotiate within your policy envelope. Source-to-contract collapsed by 4×.
System / 03
Tender·AI
A fully digital DPS under EU Directive 2014/24/EU. Continuous admission review, mini-competition orchestration, MEAT evaluation, and the audit trail supervisory bodies require.
Coming Soon
System / 04
Quality·AI
Deviations, CAPAs, change controls, periodic product reviews — handled by agents grounded in your QMS policies, escalating to humans only when judgement is required.
System / 05
Clinical·AI
TMF documents, site qualification packages, essential document checks, and clinical system validation — continuous agent-authored readiness for study startup.
System / 06
Regulatory·AI
Global registration tracking, eCTD assembly, commitment tracking across FDA, EMA, PMDA, and emerging markets. Handoffs to Veeva RIM, ArisGlobal, docuBridge.
System / 07
Safety·AI
ICSR intake with auto-triaged seriousness, MedDRA coding, narrative drafting, PSUR / PBRER / DSUR assembly. E2B(R3) ready for Argus and gateway submission.
Quick Access · Technology
Platform Overview
Architecture
Private Deployment
VPC · On-Prem
LLM Agnostic
BYO Model
Integrations
Veeva · SAP · MS365
Security & Privacy
ISO 27001 · SOC 2
Compliance
GAMP 5 · 21 CFR 11
System / 01 · Live
Validate·AI
Agentic CQV — IQ, OQ, PQ, CSV. Protocols authored from URS and P&ID, traceability matrices continuously maintained, deviations triaged, and inspection-ready evidence packs produced under your SOP library.
Agent-drafted IQ / OQ / PQ from your URS, P&ID, and SOP library. Structured fields, full traceability, reviewer-ready.
Traceability matrix
Continuously maintained trace graph linking URS → FS → DS → test cases. No orphan requirements, ever.
Deviation triage
Agent intakes, proposes root cause, and drafts CAPA within minutes. Human approves. Evidence logged immutably.
Evidence pack generation
Inspection-ready dossiers assembled on demand. Every agent action attributable, timestamped, and defensible.
Equipment qualification
Clean utilities, HVAC, thermal mapping, CIP/SIP cycle qualification — all templated and engineer-reviewed.
Kneat & Veeva handoff
Bi-directional connectors. Qualitum authors, Kneat/Veeva archive — or archive agent outputs as validated records.
Proven delivery
Reduces validation document authoring time by 70% across IQ/OQ/PQ protocols. First audited agent live in a GxP environment within 8–12 weeks from kickoff.
System / 02 · Live
Source·AI
From intake to PO. Agents draft specifications, shortlist qualified suppliers, run compliant RFQs, and negotiate within your policy envelope. Tail-spend rationalised, maverick spend eliminated.
Threshold-based controls from first request. Every ticket routed to the right workflow, no manual triage.
Supplier discovery
Agents identify qualified suppliers, run risk screening (sanctions, ESG, financial), and produce shortlists.
RFQ orchestration
Compliant RFQ cycles with normalised evaluation matrices. Bid comparison, clarifications, and scoring handled end-to-end.
Policy-bounded negotiation
Agents negotiate within pre-approved envelopes. Escalate when thresholds are breached. Full audit trail retained.
ERP handoff
Contract flip and PO generation into SAP S/4HANA, Oracle Fusion, or your ERP of record. Master data synchronised.
Category automation
Tail-spend categories procurement never has time for — now run continuously by agents. Savings appear on the dashboard.
Proven delivery
Source-to-contract cycles collapsed by 4× versus traditional procurement tooling. Supplier pre-qualification and bid comparison measured in hours, not weeks.
System / 03 · Live
Tender·AI
A fully digital Dynamic Purchasing System under EU Directive 2014/24/EU. Continuous admission review, mini-competition orchestration, MEAT evaluation, and the audit trail supervisory bodies require.
Correct CPV codes, OJEU structure, and full compliance with publication rules — drafted and dispatched by agents.
ESPD handling
Exclusion checks, selection criteria validation, and continuous admission review across the DPS lifecycle.
Mini-competitions
Orchestrated end-to-end. Clarifications, evaluation, award notifications — all within procurement law timeframes.
MEAT evaluation
Transparent weightings, defensible scoring, structured sign-off. Ready for oversight bodies and review panels.
Immutable audit trail
Every admission, evaluation, and award decision tamper-evidently logged. Defensible on review — by construction.
Supervisory readiness
Full dossiers exportable on demand. National review bodies and EU oversight — no scramble, no rework.
Built for contracting authorities
A DPS that actually runs. Admissions on time. Mini-competitions run properly. Defensible on review. Built to the letter of EU Directive 2014/24/EU.
// 04 — Private AI. Enterprise-grade.
Built for your security envelope.
Qualitum deploys as a private tenant — your VPC, your region, your models. No training on your data. No shared inference pool. The agents run inside the security envelope your InfoSec team already controls.
Agentic systems, grounded in your SOPs.
Legacy digital validation platforms built a validated, paperless environment for human authors — a digital file cabinet with workflow. Qualitum is built for a different question: what if the agents themselves author, execute, and defend the validation work, and the system of record becomes a byproduct?
Every Qualitum agent runs with full attribution, immutable logging, and explicit human-in-the-loop checkpoints. Nothing leaves your perimeter unless you approve it. Nothing runs without an audit trail.
Operating Model
Agent-first, human-reviewed
Agents author and execute. Humans review, approve, and intervene by exception.
Grounding
Your SOPs, your library
Retrieval grounded in your validated documents. No hallucinations from public training data.
Time to value
First audited agent in 8–12 weeks
From kickoff to production. Measured against legacy 6–12 month rollout baselines.
Private tenant. Your VPC. Your region.
Qualitum deploys into a single-tenant VPC on AWS, Azure, or on-prem. EU, US, or UAE data residency — your choice, your contractual commitment. No shared inference pool. No cross-tenant data flow. Ever.
Clouds
AWS · Azure · GCP · On-prem
Deploy into your existing cloud landing zone. Bring your own networking and key management.
Regions
EU · US · UAE
Data residency guaranteed in contract. Sovereignty requirements supported by construction.
Isolation
Single-tenant by default
No shared inference. No cross-tenant routing. Your tenant, your perimeter, your controls.
CI/CD
Validated pipelines
Every deployment follows a validated release pipeline with full change control and rollback.
Frontier or local. Your choice per workflow.
The Qualitum platform is LLM-agnostic. Claude, GPT, Gemini, Llama, or your in-house fine-tunes — swap per workflow, per agent, per deployment. AI agents are specialised for regulated industry functions; the underlying model is an implementation detail you control.
This means you're never locked into a single vendor, and you can route sensitive workflows to local models while keeping frontier capability available for lower-risk tasks.
Frontier
Claude · GPT · Gemini
Via zero-retention enterprise agreements. No training rights, no logging of prompt content.
Local
Llama · Mistral · In-house
Fine-tune on your SOPs. Run entirely offline. Ideal for PHI, PII, and defence-grade workloads.
Routing
Per-agent, per-workflow
Sensitive steps routed to local. Non-sensitive steps to frontier. Policy-driven, reviewable.
Compatible with the systems that already run your enterprise.
Qualitum connects into your validated systems of record. Veeva Vault (Quality, Clinical, RIM, PromoMats), Kneat Gx, MasterControl, Sparta TrackWise. ERP via SAP S/4HANA and Oracle Fusion. Procurement via SAP Ariba and Coupa. MES via Werum PAS-X and Rockwell. Collaboration via Microsoft 365 and Google Workspace. Microsoft Copilot compatible.
QMS / eQMS
Veeva · MasterControl · TrackWise · ETQ
Live handoff of agent-authored content into your QMS tenant. Validated connectors, change control aware.
Validation
Kneat Gx
Bi-directional. Qualitum authors, Kneat archives — or archive agent outputs as validated records.
ERP
SAP S/4HANA · Oracle Fusion
Master data, materials, financial lineage. Certified integrations with full reconciliation.
Procurement
SAP Ariba · Coupa · Ivalua
Source-to-pay platforms. RFQ orchestration, contract handoff, PO flip — all policy-governed.
Clinical / Reg
Veeva Vault · ArisGlobal · docuBridge
eTMF, CTMS, RIM, submission assembly, commitment tracking across FDA/EMA/PMDA.
MES
Werum PAS-X · Rockwell
Batch record, equipment, process data — integrated for manufacturing validation lifecycle.
Enterprise SSO, SCIM provisioning, and role-based agent permissions down to action scope.
Your data never leaves your perimeter.
Qualitum operates under a zero-retention posture with every model provider. No vendor training rights. No logging of prompt content. Full DPA in place. Every agent action is cryptographically signed, immutably timestamped, and attributable to a specific human-in-the-loop approval where required.
Encryption
AES-256 · TLS 1.3
Customer-managed keys at rest. TLS 1.3 in transit. Qualitum never holds encryption keys.
Permissions down to agent, action, and document. Least-privilege by default.
Audit
Tamper-evident logs
Every agent action logged with immutable timestamps and attributable signatures.
Data posture
Zero-retention
No vendor training rights. No prompt content logging. Full DPA with every provider.
Perimeter
VPC-native
All inference, all RAG, all orchestration — inside your VPC. No egress unless you approve it.
Architected around the forcing functions shaping the next decade.
Qualitum is built around the regulatory regimes that will shape the next decade of GxP and public procurement: GAMP 5 and Annex 11, 21 CFR Part 11, the EU AI Act's high-risk system requirements, and EU Directive 2014/24/EU for dynamic purchasing systems. Each certification is not a badge — it is a structural property of how the platform is built.
CSV
GAMP 5 · Annex 11
Risk-based validation for AI-enabled systems in GxP environments. Agent outputs traced to specification and test.
Records
21 CFR Part 11
Tamper-evident records, attributable signatures, and the full audit trail regulators expect.
AI regulation
EU AI Act · High-risk
Transparency, human oversight, risk management, and post-market monitoring engineered into every deployment.
Procurement
Directive 2014/24/EU
Structured DPS, lawful and defensible for contracting authorities across the EU.
Certifications
ISO 27001 · SOC 2 Type II
Independently audited annually. Report available under NDA to prospective clients.
Privacy
GDPR by design
DPIA templates, SCCs, data residency commitments, and full data subject rights workflows.