Agentic computer system validation for Heads of Validation at pharma, biotech and medical device. Qualitum authors, executes and traces the full lifecycle, CSV and CQV, URS to PQ, under GAMP 5, Annex 11 and 21 CFR Part 11. First audited IQ/OQ/PQ in weeks, not quarters.
“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 requirements live in someone’s head.
It is authored from last year’s protocol, not from the URS.
It is a spreadsheet that goes stale the day after it’s signed.
Someone opens a folder and starts searching.
Qualitum keeps the chain intact - as data, not documents.
Nineteen deliverables across the CSV and CQV lifecycle, each linked to the requirement it proves.
Clause-level, not keyword-level. Each requirement carries the regulation it comes from.
Validation, QA and engineering teams who own the URS and sign the qualification.
OEMs, skid builders and software vendors who supply GMP environments.
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. Qualitum 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. Qualitum lives where ATMP works.
The validation documents your customer’s QA approves are the same ones you have to write, for every project, against a different URS each time. Qualitum drafts them from your own templates and past projects, so your engineers review instead of retype.
Legacy platforms built a paperless environment for human authors. Qualitum makes the agents the authors. The system of record is the byproduct.
The templates moved into a browser. The authoring, the traceability matrix and the audit defence stayed with your people.
Agents author and execute the lifecycle. The system of record, and the defence pack, is the byproduct, not the project.
| 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. |
| AI inside a QMS vs. validation platform | AI features added to an existing record system. The lifecycle stays human-authored. | The validation lifecycle itself is agent-run, and the platform is validated as a GAMP 5 Category 4 baseline in its own right. |
| Version & jurisdiction tracking | Spreadsheet matrix. Drifts across country, site, equipment generations. | Live trace graph across country, site, equipment serial, SOP revision. |
Searching “AI for computer system validation” also surfaces point solutions bolted onto QMS platforms: MasterControl’s AI CAPA analytics, Veeva’s AI partner ecosystem, batch-record-review copilots such as Leucine. Those add an AI feature inside a system built to digitise paperwork; the validation lifecycle around it stays human-authored.
Qualitum’s agents author, execute and defend the CSV/CQV lifecycle itself, and the platform is validated as a GAMP 5 Category 4 baseline in its own right. You keep your eQMS. We sit above it and feed it cleaner records.
We do one thing, validation end-to-end, and make everything you already own work better.
Email one URS and the vendor test specification you validate it against: FAT, SAT, IQ or OQ. We compare what you specified with what was actually tested and name every gap, with what each one would mean at audit.
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, 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.
Bring a real URS, a real validation package, a real audit finding. We’ll show you what an agent does with it.