For Heads of Validation at pharma, biotech, and medical device - first audited IQ/OQ/PQ in weeks, not quarters.
Validate·AI authors, executes, and defends the full CSV/CQV lifecycle - URS to PQ - under GAMP 5, Annex 11, and 21 CFR Part 11.
GAMP 5 · Annex 11 · 21 CFR Part 11 · ALCOA+ · CSA-aligned
“We’ve cut more than 50% of the time out of our validation process - and the cost saving has been enormous. The evidence package is what makes it real: a system we can hand to an auditor and defend.”
Every audit finding lives in the same place: the seam between one document and the next. Four breaks, every time.
The URS is a Word file. The requirements live in someone’s head.
The protocol is authored from a template, not from the URS.
The RTM is a spreadsheet that drifts the day after it’s signed.
The inspector asks for the evidence behind URS-014. Someone opens a folder.
Qualitum keeps the chain intact - as data, not documents.
Every requirement, test step, signature, and deviation is a queryable data object in a live trace graph - not a PDF. Trace graphs replace trace matrices.
Agents draft IQ/OQ/PQ, triage deviations, propose root cause and CAPA. Reviewer-assistive by construction - never autonomous on a regulated artefact.
Single-tenant VPC on AWS, Azure, or on-prem. EU, US, or UAE residency. Air-gap capable. Zero training rights. Zero retention. Customer-managed keys.
All nine ALCOA+ criteria checked on every record at write-time and review-time. Drift between the two surfaces as a deviation draft.
Legacy digital validation built a paperless environment for human authors. We built a system where the agents do the authoring - and the record of truth is a byproduct.
The agent does the work. Workflow just routes documents between people.
Requirements and evidence are objects in a graph. The PDF is an export.
Single-tenant, in your perimeter. No shared inference pool. No training rights.
GAMP 5 Category 4 baseline. The platform is validated. The evidence defends.
The trace graph and the agent-authored protocol - with the human approval step where it belongs.
URS to PQ. Agent-authored, human-approved, auditor-ready.
SOPs author themselves. Batch records audit themselves. Every cycle.
GAMP 5 categorisation, FMEA, ICH Q9(R1) critical thinking.
Sits above your QMS - Veeva, MasterControl, ETQ, TrackWise. Doesn’t replace.
Clinical, Quality, Manufacturing, Regulatory, and ATMP - 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.
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.
Legacy platforms built a paperless environment for human authors. Qualitum makes the agents the authors - the system of record is the byproduct.
| Capability | Legacy digital validation (Kneat, ValGenesis, Veeva) |
Qualitum Agentic & data-centric |
|---|---|---|
| Operating model | Humans author in a validated digital environment. Workflow routes documents for approval. | Agents author, execute, and defend. Humans review, approve, and intervene by exception. |
| Protocol authoring (IQ/OQ/PQ) | Structured template library; manual content creation per protocol. | Agent-authored from URS, P&ID, OEM manuals, and your SOP library. |
| Requirements Traceability Matrix | Manually maintained links between URS, FS, DS, tests. Drifts over time. | Continuously maintained trace graph; no orphan requirements; live impact analysis. |
| ALCOA+ data-integrity monitoring | Sample-based audit-trail review. Periodic, often quarterly. | Every record, every cycle. All nine criteria, write-time and review-time. |
| Deployment model | Multi-tenant SaaS with a validated release cycle. | Single-tenant private deployment. Your VPC, region, models, data perimeter. |
| Time to first audited agent | 6–12 months for enterprise rollout. Years of content migration. | In production within 8–12 weeks. No content migration required. |
| URS authoring & decomposition | Manual decomposition into a structured template. Document-as-source. | Agent-decomposed 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. |
| Test script generation & execution | Test cases authored in-system; execution captured by an operator. | Generated against acceptance criteria; agent-executed where scriptable; evidence auto-captured. |
| 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. |
| Periodic review & revalidation triggers | Calendar-driven review; revalidation scope set manually. | Data-driven triggers; revalidation scope auto-scoped from the trace graph. |
| Inspection readiness | Audit trail accessible from the eQMS; evidence collected on request. | Inspector walkthrough mode; tamper-evident ledger; defence pack on demand. |
| Equipment URS-Match for procurement | Out of scope. Equipment selection lives in ERP; validation joins after the PO. | Candidate equipment scored against your URS; DQ drafted; defensible on every PO. |
| Version & jurisdiction tracking | Spreadsheet matrix. Drifts across country, site, equipment generations. | Live trace graph across country, site, equipment serial, SOP revision. |
We do one thing - validation, end-to-end, agentic - and make everything you already own work better.
No rip and replace. No migration. We sit above the system of record and feed it cleaner records than it has ever had.
Paste a system description. Get a proposed Category 3 / 4 / 5 classification with the GAMP 5 reasoning - the same first move the agent makes.
Clause-fluent answers you can forward to InfoSec, QA, and procurement without editing.
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 a defaults checklist. Low-risk functionality gets unscripted dynamic testing; high-risk gets the full scripted approach with formal evidence capture.
The FDA Draft Guidance Computer Software Assurance (Sep 2022) is operationalised, aligned with ISPE GAMP 5 Second Edition and the ISPE CSA Concept Paper.
Electronic signatures (§11.50, §11.70, §11.100, §11.200). Each signature captures printed name, date/time, and meaning, linked to records so they cannot be excised, copied, or transferred.
Audit trails (§11.10(e)). Computer-generated, time-stamped, independent of operator action. Tamper-evident at the platform layer.
Record retention (§11.10(c)). Records protected for accurate, ready retrieval across the retention period. Configurable per record class; legal-hold supported.
§4 (Validation). The platform is validated as a GAMP 5 Category 4 baseline; site configuration is validated in your CSV lifecycle.
§7 (Data storage). Data resides in your tenant, encrypted at rest with customer-managed keys.
§9 (Audit trails). Computer-generated, time-sequenced, tamper-evident. Reviewed continuously - not sampled.
§17 (Archiving). Data integrity preserved for the regulatory retention period; migration controls maintain readability.
Yes to all three. The platform is validated as a GAMP 5 Category 4 baseline. The validation evidence pack is available under MNDA - Validation Plan, Risk Assessment, IQ/OQ summary, Traceability Matrix, and Configuration Management Plan. Site configuration is validated in your CSV lifecycle.
The model layer is governed against multiple frameworks. EU AI Act - high-risk documentation per Articles 12 and 13; 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 QRM on the AI lifecycle. Model cards per agent, signed releases, drift detection.
Bi-directional, validated connectors. Three patterns: (A) author here, archive there. (B) author there, augment here - deviation triage, RTM maintenance, ALCOA+ audit on top of existing records. (C) replace the document layer, keep the eQMS.
Both. Retrospective validation is a common entry point. The agent reads legacy documentation, 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: write-time validation at capture, plus independent review-time validation against the persisted record. Drift surfaces as a deviation draft. The sample size regulators expect (100%) at a throughput humans cannot sustain. Aligned with MHRA GxP Data Integrity Guidance, 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 drafts the deviation record - what failed, what was expected, what was observed, impact, proposed root cause with citations. Handoff to your eQMS is bi-directional.
Three things, on request, in real time. The narrative - walkthrough mode generates a guided narrative from VMP through every system, deviation, and CAPA. The defence pack - every action attributable, tamper-evident, citable to the SOP clause. The trace graph - live and queryable: “show me the evidence for URS-014” in two clicks.
Yes. Per-batch evidence assembly in line with manufacturing, chain-of-identity and custody captured as data, and Annex 1 (2022) aseptic 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.
You choose, per workflow. Frontier - Claude, GPT, Gemini - via your hyperscaler partnership. Or local open-weights (Llama 3, Mistral, your fine-tune) on your GPU pool. Retraining on customer data is architecturally disabled.
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. See pricing.
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