The agentic validation platform for life sciences. Validate·AI authors, executes, and defends the full CSV/CQV lifecycle - URS to PQ - under GAMP 5, EudraLex Annex 11, and 21 CFR Part 11. Private deployment. Your tenant. Your data perimeter.
Reference - Global Top-10 Pharmaceutical Manufacturer · GAMP 5 · Annex 11 · 21 CFR Part 11 · ALCOA+ · CSA-aligned
Reference customer: a Global Top-10 Pharmaceutical Manufacturer. Deployed inside their tenant. Signed by their QA. Defended in their inspections.
Three reasons a Head of Validation buys Qualitum. Agentic, not workflow. Data-centric, not document-centric. Private, not shared. That is the difference.
The signature stays human. Agent-authored IQ/OQ/PQ from URS, P&ID, and your SOP library. Agent-triaged deviations with proposed root cause and draft CAPA. Agent-maintained Requirements Traceability Matrix - continuously. Your QA reviews, approves, signs. Reviewer-assistive by construction, never autonomous on regulated artefacts.
Every requirement, every test step, every signature, every deviation is a queryable, traceable data object - not a PDF. Trace graphs replace trace matrices. Pharma 4.0 ready by construction. ISA-95 and ALCOA+ aligned from the first commit. Your validation work becomes structured data your engineers can reason about.
Single-tenant VPC on AWS, Azure, or on-prem. EU, US, or UAE residency. Frontier or local models - Claude, GPT, Gemini, Llama, your in-house fine-tune. Swap per workflow. Zero training on your data. Zero retention. The agents run inside the security envelope your InfoSec team already controls.
Start with Validate·AI today. Expand to Operate·AI when you are ready. Risk·AI and Investigate·AI ship later in 2026 - design-partner cohorts open now.
URS to PQ. From the V-model to continuous post-go-live monitoring. The full GxP validation lifecycle, agent-authored, human-approved, auditor-ready.
SOPs author themselves. Batch records audit themselves. Every electronic record, every audit trail reviewed for ALCOA+ conformance - on every cycle.
GAMP 5 categorisation, FMEA, HACCP, ICH Q9(R1) critical thinking. The iRisk alternative, AI-native. Six design-partner customers being onboarded now.
Sits above your QMS - Veeva Vault QMS, MasterControl, ETQ, TrackWise. Doesn't replace. Reasons against your evidence, drafts the CAPA, hands the signature to QA.
Clinical, Quality, Manufacturing, Regulatory, Safety & PV, and ATMP teams - one agentic layer above the systems of record you already run.
Your clinical teams spend weeks authoring trial master file content, site qualification packages, and investigator-site validation records. Validate·AI handles the document layer so your team focuses on the science - and on the patients.
Deviations, CAPAs, change controls, and periodic reviews - handled by agents grounded in your QMS policies, escalating to humans only when judgement is required. Every action attributable. Every signature human.
From greenfield commissioning to periodic requalification of clean utilities, HVAC, and critical equipment - agent-authored, engineer-reviewed, audit-ready. Annex 1 (2022) sterile manufacturing in scope.
Regulatory Information Management is a coordination problem. Our agents manage the handoffs, chase the missing data, and assemble submission packages to agency standards - FDA, EMA, MHRA, PMDA, ANVISA.
Case intake, MedDRA coding, narrative drafting, and aggregate report assembly - handled continuously by agents under your PV procedures. Your safety team focuses on medical judgement, not document wrangling.
Cell and gene therapies do not tolerate validation overhead. Personalised batches, vein-to-vein traceability, Annex 1 sterile aseptic envelopes, and chain-of-identity controls demand evidence in days, not quarters. Validate·AI lives where ATMP works.
Authoring time saved across IQ/OQ/PQ protocols, FAT/SAT, and CSV/CSA packages.
Faster than manual CSV cycles - first audited package delivered in days, not months.
From kickoff to first audited agent running in your GxP environment.
Of records ALCOA+ checked, every cycle. Not sampled. Reviewed.
Legacy digital validation platforms built a validated, paperless environment for human authors. A digital file cabinet with workflow on top. That was the right answer for the 2010s. Qualitum answers a different question: what if the agents themselves authored, executed, and defended the validation work - and the system of record became a byproduct?
| Capability | Legacy digital validation (Kneat, ValGenesis, Veeva) |
Qualitum Agentic & data-centric |
|---|---|---|
| Core operating model | Humans author in a validated digital environment. Workflow routes documents for review and approval. | Agents author, execute, and defend. Humans review, approve, and intervene by exception. |
| URS authoring & requirements decomposition | Manual decomposition into a structured template. Document-as-source. | Agent-decomposed from stakeholder inputs into testable, risk-tagged requirement objects. Data-as-source. |
| Risk assessment (GAMP 5, ICH Q9) | Risk register maintained as a controlled document. Categorisation by SME. | Agent-proposed GAMP 5 category and ICH Q9 risk score per requirement; reviewer adjusts. |
| Protocol authoring (IQ/OQ/PQ, FAT/SAT, DQ) | Structured template library; manual content creation per protocol. | Agent-authored from URS, P&ID, OEM manuals, and your SOP library; reviewer-assistive. |
| Test script generation & execution | Test cases authored in-system; execution captured by an operator. | Test cases generated against acceptance criteria; agent-executed where scriptable; evidence captured automatically. |
| Deviation triage & CAPA drafting | Deviation captured and routed; triage performed by a human reviewer. | Agent triages, proposes root cause with citations, drafts CAPA; QA approves and signs. |
| Requirements Traceability Matrix (RTM) | Manually maintained linkages between URS, FS, DS, and test cases. Drifts over time. | Continuously maintained trace graph; no orphan requirements; live impact analysis on change. |
| Data integrity monitoring (ALCOA+) | Sample-based audit trail review. Periodic, often quarterly. | Every record, every cycle. Attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available. |
| Periodic review & revalidation triggers | Calendar-driven periodic review; revalidation scope set manually. | Data-driven triggers; revalidation scope auto-scoped from the trace graph. |
| Inspection readiness (FDA, EMA, MHRA, PMDA) | Audit trail accessible from the eQMS; evidence collected on request. | Inspector walkthrough mode; tamper-evident ledger; defence pack generated on demand. |
| Deployment model | Multi-tenant SaaS with validated release cycle. | Single-tenant private deployment. Your VPC, your region, your models, your data perimeter. |
| Time to first audited agent in production | 6–12 months for enterprise rollout. Years of content migration. | First audited agent in production within 8–12 weeks. No content migration required. |
| Equipment URS-Match for procurement decision | Out of scope. Equipment selection lives in ERP; validation joins after the PO. | Candidate equipment scored against your URS; DQ drafted; technical defensibility on every PO. |
| Version & jurisdiction tracking | Spreadsheet matrix or document index. Drifts across country, site, equipment generations. | Live trace graph across country, site, equipment serial, SOP revision. Periodic review per jurisdiction. |
Focus is the moat. We do one thing - validation, end-to-end, agentic - and make everything you already own work better.
Focus is the moat. One thing - validation, end-to-end, agentic - and we make everything you already own work better.
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.
Single-tenant VPC on AWS, Azure, or on-prem. EU, US, or UAE data residency. Air-gap capable.
Claude, GPT, Gemini, Llama, or your in-house fine-tunes. Swap per workflow.
No vendor training rights. No logging of prompt content. Full DPA. Sub-processor inventory shipped.
Annex 11 and 21 CFR Part 11 aligned. GAMP 5 Category 4 baseline. EU AI Act documented.
Okta, Entra ID, Ping. Five-tier role model enforced at retrieval time, not just the UI.
Every agent action logged with immutable timestamps and attributable e-signatures.
The evidence package is what makes this real. It's not a demo with a model in it - it's a system we can hand to an auditor and defend. That is the difference.
No softening, no marketing speak. Clause-fluent answers a CSV lead can hand to InfoSec, QA, and procurement.
The agent classifies each system per GAMP 5 Second Edition - Category 3 (non-configured COTS), Category 4 (configured), Category 5 (custom developed). Classification drives test depth, supplier assessment, and lifecycle artefact requirements.
Classification is reviewer-assistive, never autonomous. The agent proposes the category and reasoning. Your CSV lead confirms, escalates, or overrides. The decision and rationale enter the audit trail.
CSA is native. Test scripts are scoped against patient-safety, product-quality, and data-integrity risk - not against a defaults checklist. Low-risk functionality gets unscripted dynamic testing or scripted record-light. High-risk gets the full scripted approach with formal evidence capture.
The FDA Draft Guidance Computer Software Assurance for Production and Quality System Software (Sep 2022) is operationalised, aligned with ISPE GAMP 5 Second Edition (Jul 2022) and the ISPE CSA Concept Paper.
Electronic signatures (§11.50, §11.70, §11.100, §11.200). Each signature captures the printed name, date/time, and meaning. Signatures are linked to records so they cannot be excised, copied, or transferred. Two-component signing with optional biometric.
Audit trails (§11.10(e)). Computer-generated, time-stamped, independent of operator action. Operator, date/time, action, prior value. Tamper-evident at the platform layer.
Record retention (§11.10(c)). Records protected for accurate and ready retrieval across the retention period. Configurable retention per record class; legal-hold supported.
§4 (Validation). The platform itself is validated as a GAMP 5 Category 4 baseline; site configuration is validated as part of your CSV lifecycle. VSR available under MNDA.
§7 (Data storage). Data resides inside your tenant, encrypted at rest with customer-managed keys. Periodic accessibility/readability/accuracy checks scheduled and evidenced.
§9 (Audit trails). Computer-generated, time-sequenced, tamper-evident. Reviewed continuously - not sampled.
§17 (Archiving). Archived in a manner that preserves data integrity for the regulatory retention period. Migration controls maintain readability across platform upgrades.
Yes, yes, and yes. The platform is validated as a GAMP 5 Category 4 baseline. Platform validation evidence pack available to qualified prospects under MNDA - includes Validation Plan, Risk Assessment, IQ/OQ summary, Traceability Matrix, and Configuration Management Plan. Site-specific configuration is validated as part of your CSV lifecycle.
The model layer is governed under a documented regime aligned to multiple frameworks. EU AI Act - high-risk AI documentation per Articles 12 (record-keeping) and 13 (transparency); risk management per Article 9; human oversight per Article 14; post-market monitoring per Article 72. NIST AI RMF - GOVERN, MAP, MEASURE, MANAGE per agent. ICH Q9(R1) - risk-based quality risk management on the AI lifecycle. Model cards per agent, signed releases, drift detection, production-data performance monitoring. ISPE GAMP GPG on AI/ML - qualification envelope for the model layer itself.
Bi-directional, validated connectors. Three usage patterns: (A) author here, archive there - Validate·AI authors, your system-of-record stores. (B) author there, augment here - Validate·AI runs deviation triage, RTM maintenance, ALCOA+ audit, inspection-readiness on top of existing records. (C) replace document layer, keep the eQMS - Validate·AI becomes the validation-content layer; CAPAs and change controls flow to your eQMS as before.
Both. Retrospective validation is a common entry point. The agent reads legacy documentation (URS, change-control history, prior IQ/OQ/PQ packages, deviation logs), reconstructs the trace graph, identifies gaps against current GAMP 5 expectations, and drafts the remediation evidence pack.
Every record passes the nine ALCOA+ criteria on every cycle. Operationally that means write-time validation at the moment of capture, plus independent review-time validation against the persisted record. Drift between the two surfaces as a deviation draft. Sample sizes regulators expect (100%) at throughputs humans cannot sustain (1–2%). Aligned with the MHRA GxP Data Integrity Guidance (2018), WHO TRS 1019 Annex 5, and PIC/S PI 041-1.
The agent owns triage. Your QA owns the decision and the signature. The agent immediately drafts a deviation record - what failed, what was expected, what was observed, impact assessment, proposed root cause with citations. Your investigator reviews, adjusts, approves or rejects. Handoff to your eQMS (TrackWise, Veeva Quality, MasterControl, ETQ) is bi-directional.
Three things, on request, in real time. The narrative - inspector walkthrough mode generates a guided narrative from VMP through every system, every deviation, every CAPA, in the language the inspecting authority expects. The defence pack - every action attributable, every record tamper-evident, every decision citable to the SOP clause and the standard. The trace graph - live, queryable, navigable. The inspector can ask “show me the test evidence for URS-014” and get it in two clicks.
Yes. ATMP and cell-and-gene have unique validation pressure - personalised batches, vein-to-vein traceability, chain of identity, tight aseptic envelopes. The platform handles per-batch evidence assembly in line with manufacturing, chain-of-identity/custody captured as data, and Annex 1 (2022) aseptic-process alignment including CCS, PUPSIT, media fills, and environmental monitoring. The CCS is maintained as a living artefact across sites, products, and inspection cycles.
Single-tenant VPC on AWS, Azure, or on-prem. EU, US, or UAE residency. Air-gap capable. Customer-managed keys (AWS KMS, Azure Key Vault, GCP KMS). No prompt content, completions, embeddings, or telemetry leaves your network. Inference runs inside your VPC. Sub-processor inventory shipped; Full DPA available under MNDA.
You choose. Per workflow. Frontier - Claude, GPT, Gemini - via your hyperscaler partnership. Or local open-weights (Llama 3, Mistral, your in-house fine-tune) on your GPU pool. Retraining on customer data is architecturally disabled. Period.
Annual subscription on the platform; volume-based on the agentic systems you activate. No per-seat lock. Year 1 typically opens with a Pilot (8–12 weeks, one system, fixed fee) then an Enterprise agreement scoped to your deployment. See /pricing.
Deeper answers? See the Documentation hub.
Qualitum is built, operated, and audited against the regimes that matter to pharma, biotech, and medical device quality.
Risk-based validation for AI-enabled systems in GxP environments. Category-aware. Reviewer-assistive.
Clauses 4 (validation), 7 (data storage), 9 (audit trails), and 17 (archiving) addressed by architecture.
Tamper-evident records, attributable signatures, full audit trail. ALCOA+ enforced continuously.
Articles 12 and 13 documentation maintained. Human oversight, transparency, post-market monitoring engineered in.
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