# Draft the most accurate validation documents in minutes, not weeks. > Agentic computer system validation for life sciences. Qualitum Validate·AI authors, executes and defends CSV and CQV from URS to PQ under GAMP 5 and Annex 11. Canonical URL: https://qualitum.ai/ Agentic computer system validation 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 computer system validation lifecycle - CSV and CQV, URS to PQ - under GAMP 5, Annex 11, and 21 CFR Part 11. **Play explainer videoOnly takes 60-sec** Or try for free by sending us a one package → no login needed GAMP 5 · Annex 11 · 21 CFR Part 11 · ALCOA+ · CSA-aligned **Play 60 sec explainer video and understand how Qualitum works** ###### Time savings - Cycle time reduction - Authoring time reduction - Right first time > “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.” ### Validation isn’t hard. The evidence chain is. 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. ### 4 reasons why Qualitum. #### Every claim traces to its source. 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 author. Humans approve. Agents draft IQ/OQ/PQ, triage deviations, propose root cause and CAPA. Reviewer-assistive by construction - never autonomous on a regulated artefact. #### Your data never leaves your perimeter. 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. #### 100% reviewed. Not 1% sampled. All nine ALCOA+ criteria checked on every record at write-time and review-time. Drift between the two surfaces as a deviation draft. **View a free platform walkthroughand understand how it works** ### Automated validation. Not a digital files that need manual work. 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. ### Multi-Agentic System. Single Platform. Automated - but Validated by Experts. The trace graph and the agent-authored protocol - with the human approval step where it belongs. ##### Full computer system validation lifecycle. URS to PQ, authored and executed - with GAMP 5 categorisation and ICH Q9 risk scoring as steps inside the flow, not a separate product. ##### GMP procedures & ALCOA+ data integrity. SOPs author themselves. Batch records audit themselves - all nine ALCOA+ criteria, every cycle. Next: standalone deviation and CAPA handling for manufacturing-floor events, sitting above the QMS you already run. What’s next → ### Built for the teams that own the evidence. Clinical, Quality, Manufacturing, Regulatory, and ATMP - one agentic layer above the systems of record you already run. **Clinical** **Quality** **Manufacturing** **Regulatory** **ATMP / Cell & Gene** #### Accelerate clinical study startup and site readiness. 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. - Trial master file authored against your TMF reference model - Site qualification and essential document checks - continuous - Clinical system validation (EDC, CTMS, eTMF) as a repeatable pack - Connectors for Veeva Vault Clinical, Medidata Rave, Oracle Health #### Consolidate quality processes on one agentic layer. 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. - Deviation intake, triage, and CAPA drafting within minutes - Periodic product review (PPR) dossiers auto-assembled - Supplier quality audits and follow-ups orchestrated end-to-end - Connectors for Veeva QualityDocs, MasterControl, TrackWise, ETQ #### Faster facility startup. Cleaner lifecycle qualification. 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. - IQ / OQ / PQ from P&ID and URS in hours, not weeks - Clean utility qualification (WFI, PW, Pure Steam, CDA) fully templated - Thermal mapping design, analysis, and reporting in one workflow - CIP / SIP cycle qualification with sampling plan generation #### Submission-ready evidence with less rework. 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. - Global registration tracking with variation triggers - eCTD component assembly and cross-reference validation - Commitment tracking across FDA, EMA, PMDA, MHRA, ANVISA - Handoff to Veeva RIM, ArisGlobal LifeSphere, Lorenz docuBridge #### Validation that keeps up with autologous timelines. 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. - Per-batch validation evidence assembled in line with manufacturing - Chain-of-identity and chain-of-custody captured as data, not paper - Annex 1 (2022) aseptic process aligned by construction - Native integration with Veeva, AVEVA PI, Tulip, PAS-X, PharmaSuite ### End to End Validation Process. Authored, traced, defended. ### Digital validation is pase. AI Driven is the future. 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. - AI inside a QMS vs. validation platform - AI features added to an existing record system - CAPA analytics, batch-record-review copilots. 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. **Show all 15 rows ▾** 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 - not a feature layer on someone else’s record system. You keep your eQMS. We sit above it and feed it cleaner records. ### Compatibility with existing systems. We do one thing - validation, end-to-end, agentic - and make everything you already own work better. #### The systems of record your QA already runs. - Kneat Gx · ValGenesis VLMS · Veeva Vault Validation - Veeva QualityDocs / QMS · MasterControl · TrackWise · ETQ - Werum PAS-X · Rockwell PharmaSuite · Tulip - AVEVA PI / OSIsoft PI · Maximo · SAP PM - SAP · Oracle · Workday (equipment master data) - Okta · Entra ID · Microsoft 365 · Google Workspace #### The work other categories already own. - Training / LMSVeeva Training, Cornerstone, SuccessFactors own this. - Clinical ops, EDC, eTMFVeeva owns this. We validate it - we don’t replace it. - PharmacovigilanceArisGlobal, Oracle Argus. We feed clean records in. - Regulatory submissions, eCTDVeeva RIM owns this. We feed it. - ERP-side procurementSAP, Oracle, Workday own the PO. We make the equipment choice defensible. - eQMS as system-of-recordYou keep yours. We sit above it and feed it cleaner records. No rip and replace. No migration. We sit above the system of record and feed it cleaner records than it has ever had. ### Send one package. Get a real Validation Gap Report. Email us one URS and the vendor test specification you validate it against - FAT, SAT, IQ or OQ. We compare what you specified against what was actually tested and name every gap, with what each one would mean at audit. Same Validate·AI engine that runs live inside a Global Top-10 pharmaceutical manufacturer. Report back within 48 hours of us receiving your files. - You email the two files. Straight to gapcheck@qualitum.ai - no account, no login, no access to your systems. - We send you an NDA. Countersigned by us, from our side, before the analysis starts. You do not have to ask for it. - You get the report. Within 48 hours, to the address you sent from. - We delete your data. The files and everything derived from them are destroyed once the report is delivered. No retention, no training rights, no disclosure. Received by email, handled by named engineers only, deleted after delivery. If your policy needs the NDA in place before anything leaves your building, reply first and we will send it ahead. Attach your URS and your test specification to one message. PDF or Word. Prefer to talk it through first? Book a working session → ### Fifteen questions a Head of Validation asks first. Clause-fluent answers you can forward to InfoSec, QA, and procurement without editing. **How does Validate·AI handle GAMP 5 categorisation across Categories 3, 4, and 5?+** 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. **How is CSA applied? Risk-based testing - native or bolted on?+** 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. **21 CFR Part 11 - electronic signatures, audit trails, record retention. Walk me through it.+** 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. **EudraLex Annex 11 - specifically §4, §7, §9, and §17. How do you handle each?+** §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. **Is the platform itself validated? Where is the VSR? Is there a Configuration Management Plan?+** 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. **Who validates the AI? Model governance, EU AI Act, NIST AI RMF, ICH Q9(R1)?+** 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. **How do you integrate with our system of record - Kneat, ValGenesis, Veeva Vault?+** 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. **Can we use this for legacy retrospective validation, or only forward-looking projects?+** 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. **How is ALCOA+ enforced? What does “continuously audited” mean operationally?+** 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. **Deviation handling during test execution - who owns it? Who signs the CAPA?+** 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. **Inspection readiness - when the inspector arrives, what do they see?+** 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. **ATMP, cell-and-gene, Annex 1 (2022) sterile - does the platform handle those today?+** 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. **Deployment - private tenant, EU/US/UAE residency, on-prem. Walk me through the architecture.+** 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. **Models - frontier or local open-weights? Who chooses? Who retrains?+** 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. **How is this different from AI features inside our existing QMS?+** MasterControl, Veeva, and the batch-record copilots add AI inside a system of record - CAPA analytics, review-by-exception, document summarisation. Useful, and we integrate with all of it. But the computer system validation lifecycle around those records stays human-authored: someone still writes the URS decomposition, the risk assessment, the IQ/OQ/PQ scripts, and the traceability matrix. Qualitum runs that lifecycle. Agents author, execute, and defend it end-to-end, and the platform is validated as a GAMP 5 Category 4 baseline with its own Validation Plan, IQ/OQ summary, Traceability Matrix, and Configuration Management Plan - a validated system, not a feature toggle in someone else’s. Waiting for your eQMS vendor to ship AI gets you a faster document workflow; it does not get you an agent that can be inspected. **Pricing model - perpetual, subscription, outcome-based? What does Year 1 look like?+** 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. #### Read the written recommendation. We will send the recommendation to your email within a few minutes. Don’t fill: **Send me the recommendation** By submitting you agree to be contacted by Qualitum. We will not share your details. ##### On its way. Check your inbox in a few minutes. If you don't see it, search for hello@qualitum.ai or check spam. ### Stop authoring validation. Start approving it. Two ways in. Pick whichever fits the week you're having. Book a 45-minute working session with a forward-deployed engineer. Bring a real URS, a real validation package, a real audit finding. We'll show you what an agent does with it. Email your URS + test spec, get a gap report in 72h, no call required. Or email hello@qualitum.ai --- Qualitum — agentic computer system validation (CSV/CQV) for life sciences. - Site summary: https://qualitum.ai/llms.txt - Agent instructions: https://qualitum.ai/agent-instructions.md - API documentation: https://qualitum.ai/docs/api - OpenAPI specification: https://qualitum.ai/openapi.json - Contact: hello@qualitum.ai