One agentic platform for computer system validation. The full CSV/CQV lifecycle - user requirements to performance qualification, every risk assessment and periodic review after - plus GMP procedure and ALCOA+ data-integrity automation. All running privately on your infrastructure, under your QA's signature.
URS to PQ. The full GxP validation lifecycle, agent-authored, human-approved. From the V-model to continuous post-go-live monitoring. Periodic review triggered by data, not calendar.
SOPs author themselves. Batch records audit themselves. Operator knowledge layer for the shop floor - cited, traceable, training-record-aware. ALCOA+ checked on every cycle.
GAMP 5 categorisation, FMEA, HACCP, fault-tree analysis, ICH Q9(R1) critical thinking - agent-reasoned, human-approved. Runs today as a step inside the validation lifecycle, not a separate module.
Sits above Veeva Vault QMS, MasterControl, ETQ Reliance, TrackWise Digital. Deviation triage, root-cause reasoning, CAPA drafting, change-control reasoning for manufacturing-floor events. The QMS keeps the signature; the agent does the thinking.
Not a roadmap. Both run today, in customer tenants, under customer signatures.
URS to PQ - requirements decomposition, functional and design specification, IQ/OQ/PQ protocol authoring, execution with evidence capture, the traceability matrix, deviation handling during test execution, periodic review and revalidation. Agent-authored, human-approved, auditor-ready.
GAMP 5 categorisation and ICH Q9 risk scoring happen inside this flow - the agent proposes a category and a risk score per requirement, your CSV lead confirms or overrides, and test depth follows from that decision. Risk assessment is a step in validation here, not a separate product.
GMP procedures and machine manuals drafted from OEM documentation and your existing library, kept queryable for operators on the floor - cited, traceable, training-record-aware. Batch records and audit trails are checked against all nine ALCOA+ criteria on every cycle, write-time and review-time, with drift surfacing as a deviation draft.
Standalone deviation intake, triage and CAPA drafting for events arising on the manufacturing floor - distinct from the deviation handling already covered during test execution. It will sit above the QMS you already run (Veeva, MasterControl, ETQ, TrackWise) and feed it; it will not replace it. In development, not yet sellable.
Every domain a CSV/CQV professional recognises. Each runs on the same agentic spine - private deployment, regulator-fluent, reviewer-assistive.
Stakeholder inputs decomposed into testable, risk-tagged requirement objects.
Agent reads inputs, classifies per GAMP 5 category, scores risk per ICH Q9.
FS, DS, and DQ authored against URS with continuous trace links.
Agent drafts, reviewer adjusts, trace graph stays current.
Risk register maintained as live data, not a controlled document.
Agent proposes category and risk; QA approves or escalates.
IQ protocols drafted from P&ID, OEM manuals, and SOP library.
Agent assembles, pre-populates test scripts, captures evidence.
Functional test execution against acceptance criteria; deviations triaged inline.
Agent executes scriptable tests, captures evidence, escalates exceptions.
Performance verified across operating ranges; monitoring continues post go-live.
Agent drafts protocol, monitors live data, triggers revalidation.
FAT and SAT packages aligned to the V-model; commissioning evidence captured.
Agent assembles documents, ties tests to URS, hands off to IQ.
CSV/CSA evidence assembled risk-first, not document-first.
Agent runs critical-thinking decisions, focuses test effort by risk.
DEEP DIVE →Cleaning protocols anchored to PDE/ADE and toxicology-driven limits.
Agent applies EMA Q&A guidance, schedules sampling, drafts reports.
Every cleaning event scheduled, executed, signed - ALCOA+ on every cycle.
Operate·AI schedules, serves SOPs, captures records, routes to QA. MES-adjacent.
USP<1058> Group A/B/C classified, qualified, and method-validated.
Agent reads vendor manuals, applies ICH Q2(R2), drafts qualification.
Mapping studies designed, analysed, and reported in one workflow.
Agent designs probe placement, aggregates data, drafts conclusions.
Stage 1, 2, and 3 evidence assembled against the FDA 2011 lifecycle approach.
Agent runs ICH Q8/Q9/Q10, drafts PPQ, monitors continued performance.
Annex 1 (2022) aseptic envelope and media-fill evidence kept current.
Agent applies ISO 13408, schedules requalification, drafts deviations.
DEEP DIVE →Utility qualification and cleanroom classification fully templated.
Agent drafts protocols, schedules requalification, aligns to ISO 14644.
Continuous compliance instead of calendar reviews.
Agent monitors triggers in the trace graph, scopes revalidation work.
Every record, every cycle - not sampled, reviewed.
Agent applies ALCOA+, surfaces anomalies, drafts deviations.
Live trace graph between URS, FS, DS, test cases, and signed records.
Agent maintains continuously; reviewer sees orphan-free state always.
Deviation triaged in minutes; CAPA drafted with citations; eQMS-integrated.
Agent proposes root cause; QA owns the decision and the signature.
Site-level VMP authored against Annex 15 and maintained as data.
Agent drafts initial VMP, maintains revisions, links to site evidence.
Inspector walkthrough mode and defence pack generated on demand.
Agent assembles narrative, evidence, and citations for the inspector.
Candidate equipment scored against your URS for the procurement decision. Defensible. Auditable.
Inside Validate·AI - technically defensible, vendor-neutral, no PO data leaves your perimeter.
Validation status across country, site, equipment, and regulatory permutations - a live trace graph, not a spreadsheet.
Trace graph tracks every variant: site, regulator, equipment serial, SOP revision. Periodic review per jurisdiction.
Book a 45-minute working session. Bring a real URS, a real validation package, a real audit finding. We'll show you what an agent does with it.
Book a working sessionOr email hello@qualitum.ai