The full validation lifecycle - one agent.
Validate·AI covers the complete CQV surface area: commissioning, qualification, and validation across equipment, systems, and processes. One agent. One audit trail. One source of truth.
Ingest → reason → draft → execute → defend.
Five agent stages, fully observable. Every step produces a GxP-aligned artifact, signed by a human reviewer, with an immutable audit trail back to the source requirement.
Read your stack
URS, SOPs, P&IDs, drawings, vendor manuals, LIMS, SharePoint, prior protocols. Everything, parsed and indexed inside your tenant.
Apply regulation
GAMP 5 risk classification, Annex 11 and 21 CFR Part 11 mapping, ALCOA++ scoring. The agent knows what applies and why.
Author artifacts
IQ, OQ, PQ, FS, DS, test cases, RTM, summary reports. Drafts match your approved template, voice, and numbering.
Run & witness
Execute test scripts against live systems. Capture evidence. Flag deviations. Propose root cause and CAPA for human approval.
Audit on demand
Tamper-evident ledger, attributable e-signatures, live trace graph. Regulators see the same view your QA team does.
What it reads. What it produces.
Validate·AI connects to the data you already have and produces the artifacts your QA team already recognises - nothing invented, nothing orphaned.
Data sources
- User requirements (URS, stakeholder interviews)
- SOP library (SharePoint, Veeva, file share)
- Prior validation protocols and reports
- LIMS (LabWare, STARLIMS, Thermo SampleManager)
- Vendor manuals, P&IDs, equipment drawings
- Regulatory corpus (FDA, EMA, ICH, ISPE)
- ERP & asset registers (SAP, Oracle)
Artifacts produced
- URS, FS, DS - aligned and traced
- IQ, OQ, PQ protocols + test cases
- Summary reports + executive briefings
- Requirements traceability matrix (RTM)
- Deviation reports + proposed CAPA
- Audit trail - every token, every edit
- 21 CFR Part 11 signed record set
A respectful side-by-side.
Digital validation platforms built a validated, paperless environment for human authors - a digital file cabinet with workflow. Qualitum is built for a different question: what if the agents themselves author, execute, and defend the validation work, and the system of record becomes a byproduct? We respect what digital validation accomplished. We're building what comes next.
| Capability | Digital validation | Agentic validation |
|---|---|---|
| Operating model | Humans author documents in a validated digital environment. Workflow routes them for review and signature. | Agents author and execute. Humans review, approve, and intervene by exception. |
| Protocol authoring | Template library. Structured form fields. Content typed by a validation engineer over days. | Agent-authored IQ / OQ / PQ from URS, P&ID, and your SOP library in minutes, not days. |
| Test execution | Protocols executed manually. Evidence attached by an operator to a structured record. | Agent executes scriptable tests against live systems. Captures evidence. Escalates exceptions. |
| Deviation triage | Captured in the eQMS and routed. Triage performed by a human reviewer against prior CAPAs. | Agent triages, proposes root cause with citations, and drafts CAPA. Human approves. |
| RTM generation | Manual linking between URS, FS, DS, and test cases. Drift over time as specifications change. | Continuously maintained trace graph. No orphan requirements. No stale links. |
| Change control | Engineers assess impact. Documents re-routed for signatures. Impact analysis performed by hand. | Agent computes downstream impact across RTM, drafts change request, and surfaces regressions. |
| Analytical instrument validation | USP<1058> instrument classes mapped to templates. Protocols authored per instrument, per site. | Agent reads vendor manual, classifies per USP<1058>, and produces the qualification package. |
| Audit readiness | Audit trail accessible from the eQMS. Evidence collected on request. | Regulator-ready view. Tamper-evident ledger. Live trace. Every token, every edit, every approval. |
| Architecture | Document-first. Multi-tenant SaaS with validated release cycle. | Agent-first. Private tenant. Your cloud, your models, your data perimeter. |
| Time-to-value | 6–12 months for enterprise rollout. Years of content migration. | First audited agent in production within 8–12 weeks. No migration required. |
Analytical instrument validation with Validate·AI.
USP<1058>, Annex 15, and ICH Q2 aligned. HPLC, GC, MS, FT-IR, dissolution, particle size, NMR. The agent reads the vendor manual, classifies the instrument, and produces the qualification package - from URS to PQ, with method transfer baked in.
OQ Protocol · HPLC-BSL-0412
Operational qualification of Agilent 1290 Infinity II HPLC, Basel QC Lab, for use in impurity profiling per SOP-ANA-0847.
URS-014 → FS-03 → DS-02 → OQ-01…05
- Authored by Validate·AI. Reviewed by human. Audit trail: every token.
Architected around the regimes that matter.
Validate·AI is engineered to produce GxP-aligned output by construction - not by policy review. Compliance isn’t a band-aid layered on top; it’s how the system works.
Risk-based CSV
Category 1–5 classification applied automatically. Risk-proportionate protocols. Supplier assessment. Critical thinking by construction.
Computerised systems
Validation, data, accuracy checks, audit trails, change control, business continuity - every requirement mapped and evidenced.
Electronic records
Tamper-evident ledger, attributable e-signatures, sequence of actions, open-system safeguards, record retention integrity.
Data integrity
Attributable, Legible, Contemporaneous, Original, Accurate - plus Complete, Consistent, Enduring, Available. Scored per record.
Analytical instruments
Group A / B / C classification. Qualification requirements mapped per group. Method validation lifecycle integrated.
Method & quality risk
Method validation per ICH Q2(R2). Quality risk management per Q9. Pharmaceutical quality system per Q10. Native citation support.
High-risk AI governance
Human oversight, transparency, risk management, post-market monitoring - operational, not documentary.
AI/ML in GxP
Aligned with the ISPE GAMP Good Practice Guide on AI/ML. Qualification envelope for the model layer itself.
Sits on your stack. Your data never leaves your tenant.
Kneat Gx
Bi-directional connector. Validate·AI authors, Kneat archives - or archive agent outputs as validated records.
Veeva Vault Quality
QualityDocs, QMS, Training. Live handoff of agent-authored content into your Vault tenant.
MasterControl
Documents, processes, and training events synchronised with agent actions.
Sparta TrackWise
Deviation, CAPA, and change control handoff via validated connector.
LabWare · STARLIMS
Instrument registry, method library, and qualification status bi-directionally synced.
Thermo SampleManager
Sample lifecycle and instrument-event feed into agent-authored PQ runs.
SAP S/4HANA · Oracle
Asset register, maintenance records, and equipment master-data alignment.
Werum PAS-X · Rockwell
Manufacturing execution and batch record data feed into process validation.
SharePoint · OneDrive
SOP libraries, prior protocols, drawings - read-native, write with governance.
Okta · Entra ID
Enterprise SSO, SCIM provisioning, role-based agent permissions.
First audited IQ/OQ/PQ package in 9 weeks. Zero re-work on the QA review.
A top-5 global pharma deployed Validate·AI to qualify a new analytical lab. Instead of 4 validation engineers for 5 months, one engineer supervised the agent across 34 instruments and the full method library.
Stop authoring validation. Start approving it.
Book a 45-minute working session with a forward-deployed engineer. Bring a real SOP, a real validation package, or a real qualification backlog.
Book a working sessionOr email hello@qualitum.ai