// the private agentic platform for regulated industries — validation, operating procedures & data integrity, enterprise procurement, EU public procurement. same agentic core · four regulatory regimes.
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Full product story, integrations, regulatory posture, and how Qualitum sits above your validated systems of record.
Agentic procedures, knowledge & data integrity. SOPs and machine manuals authored from OEM docs and your library, queryable for operators, audited for ALCOA+ on every record. GMP & 21 CFR Part 11.
100% records checked, every cycle
Procurement
● live
System / 03
Source·AI
Agentic enterprise procurement. Agents draft specifications, shortlist qualified suppliers, run compliant RFQs, and negotiate within your policy envelope. Source-to-contract collapsed by 4×.
4× faster sourcing cycles
Soon
System / 04
Tender·AI
Agentic EU public procurement. Continuous admission review, mini-competition orchestration, MEAT evaluation, and the audit trail supervisory bodies require — including fully digital DPS under Directive 2014/24/EU.
100% defensible to oversight
Operations & HSE
● live
Module · HSE
HSE
Voice-first incident reporting, ISO 45001-aligned audit packages, regulatory form pre-fill. Field workers report by speaking; the system transcribes, structures, and logs — defensible on inspection.
System-of-Record HandoffBi-directional connector for Kneat Gx, ValGenesis. Qualitum authors; your validated system archives.
Use Cases
Equipment Validation
FT-IR, HPLC, autoclaves, lyophilisers — qualified, calibrated, and maintained with full lifecycle evidence.
CSV
Laboratory data systems, LIMS, MES — validated against requirements with reusable evidence packs.
Commissioning & Qualification
Cleanroom HVAC, WFI, Pure Steam — design, install, test, and operate to spec, templated.
GAMP 521 CFR Part 11EU Annex 11IQ / OQ / PQCSVKneat GxValGenesisAudit-Ready
System / 02 · Operations & Data Integrity
Operate·AI
Agentic procedures, knowledge & data integrity. SOPs and machine manuals authored from OEM documentation and your existing library, made queryable for operators, audited for ALCOA+ on every record. Authors the procedure. Makes it knowable. Audits the record. Your QA signs. Sits above Veeva Vault QualityDocs, MasterControl, Werum PAS-X, and OSIsoft PI.
// In Development · Coming Soon
100%
records checked, every cycle
ALCOA+
data integrity, continuous
GMP
21 CFR Part 11 · Annex 11
Planned Capabilities
SOP AuthoringGenerates SOPs and machine manuals from OEM documentation and your existing library — queryable for operators.
ALCOA+ Continuous AuditEvery record audited against ALCOA+ data integrity criteria — every cycle, not sampled.
Operator-Facing KnowledgeProcedures made queryable in the language operators actually use — fewer errors, fewer deviations.
21 CFR Part 11 RecordsTamper-evident records with attributable e-signatures — regulators find everything where they expect it.
QA Sign-Off LoopAuthors the procedure. Audits the record. Your QA reviews and signs — the signature stays human.
GMPALCOA+21 CFR Part 11EU Annex 11Veeva VaultMasterControlWerum PAS-XOSIsoft PI
Live · HSE Module
Module · Health, Safety & Environment
HSE
Voice-first HSE incident reporting, risk assessment, and compliance logging. Field workers capture incidents on-site via mobile or voice. The system transcribes, structures, and logs. ISO 45001-aligned outputs, regulatory form pre-fill, non-conformance tracking — all defensible on inspection. Available now at hse.qualitum.ai.
HSE is live at hse.qualitum.ai. Voice-first incident capture, ISO 45001-aligned audit packages, regulatory form pre-fill — incidents are structured, logged, and inspection-ready without anyone returning to a desk.
Capabilities
Voice Incident CaptureField workers report incidents by speaking — the system transcribes, structures, and logs the report automatically.
ISO 45001 AlignedAll outputs align with ISO 45001 occupational health and safety management requirements.
Non-Conformance TrackingLogs deviations, assigns corrective actions, and tracks resolution status through to closure.
Regulatory Form Pre-FillGenerates submission-ready forms for national regulatory authorities in the correct format.
Risk Assessment AutomationProduces structured risk matrices from incident data and assigns residual risk ratings.
Private DeploymentRuns on your infrastructure — incident data never leaves your environment or reaches external AI providers.
ISO 45001Voice-FirstMobile CaptureRegulatory Pre-FillNon-ConformanceRisk MatrixLive · hse.qualitum.ai
Live · Enterprise Procurement
System / 03 · Enterprise Procurement
Source·AI
Agentic enterprise procurement. Agents draft specifications, shortlist qualified suppliers, run compliant RFQs, and negotiate within your policy envelope. Source-to-contract collapsed by 4×. Sits above SAP Ariba, Coupa, Jaggaer, and Oracle Fusion. Your sourcing team reviews 30 offers × 200 line-items in minutes, not weeks.
Reference outcome · global top-10 industrial manufacturer: €40M tail-spend rationalised in 90 days. 12 categories competed in parallel; offer-to-recommendation reduced from 6 weeks to 4 days; defensible to internal audit and SOX controls.
Capabilities
Specification DraftingAgents draft technical specifications from internal context, prior buys, and your category playbooks.
Supplier Discovery & QualificationSearches and pre-qualifies suppliers against compliance, capability, risk, and ESG criteria before human review.
RFQ OrchestrationRuns compliant RFQs end-to-end with normalised evaluation matrices and weighted scoring.
Policy-Envelope NegotiationNegotiates within thresholds your team configures. Escalates anything outside the envelope — no rogue agent moves.
Decision MemoGenerates a formal decision memo with full justification trail for governance, internal audit, and SOX controls.
S2P HandoffSits above SAP Ariba, Coupa, Jaggaer, Oracle Fusion. Contract handoff and PO flip stay in your validated S2P.
SAP AribaCoupaJaggaerOracle FusionSOX-AlignedInternal AuditISO 27001Live · source.qualitum.ai
System / 04 · EU Public Procurement
Tender·AI
Agentic EU public procurement. Continuous admission review, mini-competition orchestration, MEAT evaluation, and the audit trail supervisory bodies require — including fully digital Dynamic Purchasing Systems under EU Directive 2014/24/EU. Buyer-side, not bidder-side. Sits above TED, eTendering, PPDS, and member-state platforms. Defensible to the EU Court of Auditors.
// In Development · Coming Soon
100%
defensible to oversight
DPS
fully digital, 2014/24/EU
MEAT
transparent weighted eval
Planned Capabilities
OJEU-Structured NoticesContract notices generated with correct CPV codes and full OJEU structure. Published to TED on time, every time.
ESPD & Exclusion ChecksAutomated ESPD handling, exclusion verification, and selection criteria evaluation — continuous, not batched.
DPS LifecycleDynamic Purchasing Systems run end-to-end: admissions on time, mini-competitions run properly, audit trail intact.
Oversight-Ready Audit TrailTamper-evident records ready for the EU Court of Auditors, national review bodies, and supervisory authorities.
Platform ConnectorsIntegrates with TED, eTendering, PPDS, and member-state e-procurement platforms — buyer-side workflows only.
Directive 2014/24/EUEU AI Act (high-risk)MEATDPSTEDeTenderingPPDSEU Court of Auditors
Privacy & Security
Built for environments where data leaks are not options.
// regulated industries, critical infrastructure, and public sector bodies operate where security is not a feature — it is a precondition. private tenant, zero-egress inference, customer-managed keys, 5-tier permission model enforced at retrieval.
Three things we got right before anything else.
The architectural decisions that determine whether everything else holds.
Encryption at rest & in transit
All tenant data — documents, metadata, vector embeddings, audit records — encrypted with AES-256 under customer-managed keys in your KMS. TLS 1.3 end-to-end. Qualitum never holds your encryption keys.
Identity & authentication
SAML 2.0, OIDC, OAuth 2.0, LDAP. Native connectors for Microsoft Entra ID, Okta, Ping, and Active Directory with SCIM provisioning. MFA enforced at platform level. No parallel user directory.
Five-tier role-based access
Platform Admins → Process Owners → Knowledge Owners → Validators → Agent Users. Every permission enforced at document level. RAG retrieval respects RBAC at query time — agents cannot surface what the user cannot see.
14d
to live production
0
data sent externally
5
tier RBAC at retrieval
∞
perpetual licence
Inside your tenant. Your cloud. Your region. Your keys.
Qualitum is a single-tenant deployment model. Each customer runs in a dedicated environment on their chosen cloud, in their chosen region, under their IAM. There is no shared data store, no shared model state, and no shared inference pool between customers — ever.
Cloud
AWS · Azure · GCP · on-prem. Bring your own. Air-gap supported for classified workloads.
Region
EU (Frankfurt, Ireland, Paris), US, UK, UAE, Singapore, Sydney — pinned to your residency requirement.
Network
Your VPC. Private subnets, VPC endpoints, PrivateLink. No public ingress required for the agent runtime.
Storage
Your buckets, your database. Object storage in your S3/Blob/GCS. Postgres in your RDS/Cloud SQL. Your snapshots, your retention.
Keys
You hold them. Customer-managed KMS keys (AWS KMS, Azure Key Vault, GCP KMS). Revoke anytime and the data becomes unreadable.
Egress
Zero. Inference happens inside your VPC. No prompt content, no completions, no embeddings, no telemetry leaves your network.
Zero Egress Architecture: The LLM model runtime is deployed inside your private network or dedicated environment. All inference happens locally. No prompt content, no completions, no embeddings, no diagnostic telemetry is transmitted to external providers — ever.
Copilot is a chat surface. Qualitum is operational agents.
Microsoft Copilot, ChatGPT Enterprise, and Gemini Enterprise are general-purpose assistants: a chat box over your documents. Qualitum is not a chat box. It is a set of domain-specific, validated operational agents that execute regulated workflows end-to-end.
Different primitive
Copilot: user asks, model responds. Qualitum: validated agents author, execute, and defend a specific regulated workflow. No human prompt engineering required.
Different deployment
Copilot: multi-tenant SaaS in Microsoft's / OpenAI's cloud, under their keys. Qualitum: single-tenant. Your cloud, your region, your keys, your IAM. Air-gap capable.
Different regulatory posture
Copilot: generic enterprise compliance. Qualitum: purpose-built for GxP, Annex 11, 21 CFR Part 11, GAMP 5, EU AI Act, Directive 2014/24/EU. Validated agent outputs.
Training on your data: with Copilot it's a contractual opt-out, subject to vendor terms. With Qualitum it's architecturally impossible — the pipeline does not exist. Model weights sit inside your tenant. Inference runs in your VPC. There is nowhere for the data to go.
The two are not competitors — they solve different problems. Most Qualitum customers continue to run Copilot for general productivity. Qualitum handles the regulated work Copilot is not architected for.
A private agentic runtime, not an LLM wrapper.
Qualitum is the agentic layer. It combines domain knowledge, deterministic workflow, and context isolation into auditable agents that execute regulated work. The LLM is a component we swap. The agent behaviour — what gets drafted, how it is checked, what the audit trail looks like — is ours.
What this means practically: When the next-generation frontier model ships, your Source·AI gets better overnight. When your InfoSec team decides one provider is off the approved list, you flip to Anthropic, Gemini, or a self-hosted LLaMA with a config change. No re-implementation. No vendor lock-in.
Domain knowledge
Agents pre-trained on industry-specific process patterns, regulatory requirements, and domain terminology — GxP, procurement law, EU AI Act.
Deterministic workflow
Process rules layered above the LLM ensure consistent, auditable outputs — regardless of which model is running underneath.
Context isolation
Each agent operates in a fully isolated context. No data bleed between agent types, no shared conversation state across tenants.
LLM agnostic by design.
Qualitum is not tied to any single model. Bring your preferred LLM — Azure OpenAI, Anthropic Claude, Google Gemini, a self-hosted Mistral or LLaMA, or a custom fine-tune — or use the default private model runtime that ships with the platform. Route different workflows to different models.
Why it matters: LLM capabilities evolve faster than procurement cycles. Agnostic architecture means your agents improve as models improve — with no re-implementation, no vendor renegotiation, and no forced migration path when your current provider's policy changes.
Azure OpenAI
EU data boundary, Microsoft Entra ID integration, private endpoint.
Anthropic Claude
Claude via AWS Bedrock or direct enterprise API with zero data retention.
Google Gemini
Gemini via Vertex AI in your GCP project, no cross-project data flow.
Self-hosted
LLaMA 3, Mistral, Qwen, or your in-house fine-tune on your GPU fleet.
Fully automated CI/CD pipeline. From contract to live production agents in under 14 days for standard connectors. All environment provisioning defined as code — repeatable, version-controlled, auditable.
Infrastructure as Code: Tenant setup, connector configuration, and agent deployment are automated from a single pipeline run. Your SRE team sees the full Terraform / Bicep / CloudFormation manifest. Nothing is "magic."
Isolated tenants
Each client runs on a fully isolated tenant. No shared infrastructure, no shared data stores, no cross-client exposure of any kind.
Cloud agnostic
Deploy on AWS, Microsoft Azure, Google Cloud, or on-premises. The pipeline is cloud-neutral and infrastructure-agnostic.
Air-gap capable
For classified or high-security environments, Qualitum can be deployed in a fully air-gapped configuration with no external network dependency.
Enterprise-grade identity and access management out of the box. Qualitum integrates with your existing identity provider — no parallel user directory, no shadow credential management, no separate login portal. If someone loses access in your IdP, they lose access to Qualitum the same second.
SSO / LDAP
Active Directory, Entra ID, Okta, Ping, any LDAP-compatible IdP via SAML 2.0 or OIDC.
5-tier RBAC
Granular roles enforced at the retrieval layer — not just the UI. Governs which agents, data sources, and outputs each role can access.
Automated lifecycle management. Accounts provision and deprovision automatically when employees join, move, or leave.
Microsoft Entra ID: For M365-deployed tenants, authentication flows through Microsoft Entra ID. Users sign in once with existing corporate credentials — no additional accounts, no separate passwords, no parallel identity surface to manage.
Azure AD / Entra IDOktaPingSAML 2.0OIDC / OAuth 2.0LDAPSCIMMFA5-Tier RBAC at retrieval
Certified where it matters. Aligned where it is required.
Qualitum is built, operated, and audited against the regimes that govern the next decade of regulated work.
ISO/IEC 27001
InfoSec management system. Annual surveillance audit, recertification every three years.
Privacy information management extension. Aligned with GDPR controller and processor obligations.
GDPR · By design
Article 25 architecturally enforced. Data minimisation at ingest, DPIA templates ship with the platform.
21 CFR Part 11
US FDA electronic records and signatures. Tamper-evident logs, attributable e-signatures, validation evidence.
EU Annex 11
EMA GxP — computerised systems used in GMP-regulated activities. Risk-based validation lifecycle.
GAMP 5
ISPE Good Automated Manufacturing Practice — second edition, AI/ML-aware.
NIS2 / DORA
EU cyber resilience & financial sector digital operational resilience. Incident reporting aligned to disclosure windows.
EU AI Act
High-risk system alignment. Conformity-assessment-ready technical file ships with deployment.
ISO 27001SOC 2 Type IIISO 27701GDPR21 CFR Part 11EU Annex 11GAMP 5HIPAANIS2DORAEU AI ActDirective 2014/24/EU
Everything your InfoSec team will ask.
The hard questions, answered the way the CISO needs them answered.
Can you train on our data?
No — and not because of a contractual clause. Because the pipeline does not exist. Inference runs inside your tenant; model weights never leave it; there is no upstream channel to Qualitum. Even if we wanted to, there is nowhere for the data to go.
What happens if we terminate?
The deployment is yours under the perpetual licence — it keeps running. You retain all data, all audit logs, all configurations, and all fine-tune weights. We can offer a 90-day transition package where we hand over knowledge-transfer documentation and detach from operational support; after that your platform keeps operating without us.
Who holds the encryption keys?
You do. Keys live in your KMS (AWS KMS, Azure Key Vault, GCP KMS, or your on-prem HSM). We configure the platform to use them; we never have access to the key material. If you revoke the key, Qualitum can no longer read your data — and neither can anyone else.
Can you see our prompts, our documents, or our agent outputs?
No. Qualitum engineers have no standing access to your tenant. Break-glass support requires explicit, time-bound, customer-approved access through your IAM — every session logged in your audit trail, not ours. Most customers never grant it.
What about the LLM provider — does OpenAI or Anthropic see our data?
Only if you choose a hosted LLM and only under the contractual terms you sign with them. Most regulated customers run inference through Azure OpenAI in their own EU data boundary, Bedrock in their own AWS account, Vertex in their own GCP project, or a self-hosted open-weight model — in which case no external provider sees anything. Every option is configurable per workflow.
How do you handle GDPR Article 25 / privacy by design?
The architecture is the privacy control. No telemetry egress, no shared inference, no cross-tenant data flow, RBAC enforced at retrieval. Data minimisation is enforced at ingest (we index only what you scope). DPIA templates and sub-processor inventory ship with the platform.
Is there an air-gapped deployment option?
Yes. Fully air-gapped deployments are supported for defence, public-sector classified environments, and pharma facilities with strict network isolation. A self-hosted open-weight model runs locally; updates are shipped via signed, offline artefacts; no outbound network dependency exists.
How do you handle the EU AI Act?
Qualitum deployments classified as high-risk AI systems ship with a conformity-assessment-ready technical file: risk management documentation, data governance records, logging, human oversight configuration, and transparency artefacts. We align to the August 2026 enforcement timeline.
Can we audit the codebase?
Yes. Enterprise-tier customers receive full source access under the perpetual licence, with a signed SCA (source-code access) agreement. Your security team can review, pentest, fork, and extend the platform. Most customers do not modify it; all of them can.
What is your incident response SLA?
Sev-1 incidents: 15-minute acknowledgement, 4-hour mitigation target, post-incident RCA within 5 business days. Sev-2 and Sev-3 scaled accordingly. Every incident reported to you within the NIS2 / DORA disclosure windows applicable to your jurisdiction.
Bring your hardest questions. Book a working session with a Qualitum security engineer — we walk through architecture, audit trail, and the exact answers your CISO is paid to ask. Book a security review →