Your AI is guessing. Qualitum is not.

Meet Qualitum, the world’s first AI Chief Quality Officer.

One platform for every requirement and document check. Agents for every workflow, working 24/7.

Get a free gap reportMeet the agents

Deployed inside a Global Top-10 pharmaceutical manufacturer. Signed by their QA.

The problem

Meeting every standard, every time, is brutally hard.

Quality assurance should prevent mistakes before they happen. Today it still means people reading thousands of pages by hand, like checking three supplier offers against one specification.

Time

Weeks of reading.

Hundreds of requirements checked against dozens of documents, line by line, by hand.

Expertise

Scarce experts.

Only a few people can judge a spec against evidence. They are the bottleneck on every deadline.

Method

No two reviewers agree.

What counts as met, partial or missing lives in people’s heads. It leaves when they do.

Cost of mistakes

One missed line costs millions.

A failed audit, a rejected batch or a lost tender costs far more than finding the gap.

Matt (Matevž) Baškovc, Founder & CEO of Qualitum
Why we built Qualitum · A note from our founder

Quality is the 1% that makes or breaks a company. Until now, only the biggest could afford to get it right.

Every product that reaches a patient, a plane or a power grid stands on quality assurance. It is the standard customers trust and auditors test. When it slips, one missed line can sink a launch, a batch or a brand.

Doing QA properly takes rare people: auditors, validation engineers and subject-matter experts for every standard, applied to every document, every time. No team can hire enough of them.

So we built Qualitum: an AI Chief Quality Officer with a swarm of agents that learn your company’s knowledge and do the expert work, with proof behind every answer.

  • Better quality
  • Better decisions
  • Competitive edge
  • Compliance and trust
Matt BaskovcFounder & CEO · MBA · 3x exits · ex-BotechISO 27001 Lead Auditor · Cybersecurity & tech expert
Book a 1:1 with meConnect with me

ChatGPT gives you a best guess. Qualitum gives you audit-ready proof.

87% of buying decisions made with frontier AI models still get re-checked by a person. In B2B it is every decision, by hand. When an answer has even a 1% chance of being wrong, the consequences are brutal. And someone has to sign for it.

See how Qualitum proves it
Solution

Every quality check,
turned into apples to apples.

Qualitum reads every document and puts them in one structured comparison. Every cell traced to its source page. One place for all the work.

InputsAny format, any language
DOC
Customer URSrev. 4 · Word
PDF
Supplier offers3 files · DE / EN
XLS
Comparison sheetsExcel matrices
REG
RegulationsAnnex 11 · Part 11 · GAMP 5
PDF
Machine & technical guidesFR / IT / DE
PDF
Vendor documentsCertificates · FAT · DoC
Compare all three offers against URS rev. 4
Done. 312 requirements compared across 4 documents. 7 deviations flagged for your review.
RequirementURS rev. 4Supplier ASupplier BSupplier C
3.2.1 Operating range−20…+55 °CMetTR-118 §4.2MetSpec p.12Partial+45 °C only
4.2.7 Reject verificationEvery packMetFS-M04 §3.1Metp.22Metp.9
6.1.3 Data retention10 yearsMetFS §2.4Conflict7 years, p.31Metp.14
6.1.7 Audit trail PDF/ARequiredMetOQ-23Metp.33GapNo evidence
8.4.1 Changeover< 15 minPartial18 min, p.40Metp.45Metp.21
Score312 req.291 met274 met184 met
OutcomesWhat you get from every comparison
10×faster comparison
50%less reading
1:1apples to apples, every offer on the same terms
Bestquality decision, every time, with proof
Principle

Finally, apples to apples. Without hundreds of hours.

Before anything is compared, every document is normalised to the same requirement, the same unit and the same language. Only then is it scored.

Same requirementEvery offer mapped to URS IDs, not to its own chapter numbers.
Same units°C, years, minutes and dB(A), converted before comparison.
Same languageGerman, French and Italian sources read side by side with English.
Same evidence barNo page, no status. Claims without proof count as gaps.
50%lower costGaps caught at the document stage, not as a recall or a customer complaint.
ISO-leveltrust on autopilotConsistent, proven quality that customers and auditors can rely on.
80%less wasteStandardised checks that save time, material and rework.
60%better decisionsEvery offer scored on the same evidence, so the right choice is clear.

Validation that drafts itself

URS-014 rev. 4 received from Engineering.

Reading 4 linked documents… no action from you.

OQ-11 drafted, traced to 9 requirements.

Ready for your signature. 1 conflict flagged for review.

Document comparison without chasing evidence

Qualitum · Document comparison
URS rev. 4 vs. 3 supplier offers · 318 requirements
Supplier A291
Supplier B274
Supplier C184
Every score linked to the page that proves it.
Your AI CQO runs 10+ quality agents, 24/7

One agent for every job your quality team does by hand.

See all agents
Built for buyers atPharma, biotech and medical device companies
How it works

Learn. Execute. Sign. Three steps, every time.

The full seven-step engine is on the Consensus OS page. Here is the short version.

1Learn

Consensus OS builds your quality brain first.

Your requirements, SOPs, templates, past projects and the current regulations become one knowledge graph. Nothing is answered from the open internet.

2Execute

Agents do the work, requirement by requirement.

Each agent does one job. Together they compare every document against every requirement and show you the result side by side.

Evidence, not guesses.Every result is matched to a source clause. Several independent models must agree. If they don’t, a person decides.
Don’t believe us. Inspect us.Every cell opens the document, page, clause and version behind it.
3Sign & record

Your qualified person signs. Everything is logged.

Nothing regulated moves without a person. Every draft, check, edit and signature is recorded, attributable and exportable for the auditor.

Customers
“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.”
Portrait of a head of quality engineering
Head of Quality EngineeringGlobal Top-10 Pharmaceutical Manufacturer
>50%Time cut from the validation process
70%Less authoring on IQ/OQ/PQ
48 hFrom two documents to a gap report
3–4×Faster CSV cycle vs. manual
8–12 wkTo first agent in production

Measured inside a Global Top-10 pharmaceutical manufacturer.

What your AI CQO replaces

A quality department’s workload. One platform.

Your experts stay. The reading, cross-checking and first drafts move to agents.

Without QualitumWith Qualitum
ProtocolsValidation engineers write every IQ/OQ/PQ by hand.[€X] per protocolThe Drafting Agent writes them in your templates. Engineers review and sign.70% less authoring
Compliance matricesConsultants build them in Excel, project by project.[€X] per projectThe Evidence Agent links every row to the page that proves it.
Cross-readingReviewers read five documents to check one requirement.One review pass, with the matching passage in each document highlighted.
Supplier offersCompared in Excel over weeks, each offer in its own format.[€X] per tenderThe Supplier Comparison Agent scores every offer against your URS, apples to apples.
Audit prepWeeks assembling evidence packs before every audit.[€X] per auditAn audit-ready record you can export on any day.
Coverage100% is not possible by hand. Teams sample.Every requirement, every document, every cycle.
AvailabilityOffice hours. 24/7 is not possible.Agents work 24/7. People sign when they are ready.
Two sides, one engine

One side writes the requirements. The other has to prove them.

Your AI CQO works for both. Same evidence chain, from both ends.

Buyers & operators

Check what you receive.

  • Requirements split into testable, risk-tagged items.
  • Supplier evidence matched to the page that proves it.
  • Gaps found before you sign the PO or the acceptance.
  • Bids scored against your tender, clause by clause.
Supplier Comparison Agent
Builders & suppliers

Prove what you built.

  • Protocols drafted from your engineering data: IQ/OQ, FAT/SAT, test specs.
  • Compliance matrices answered against the customer’s URS.
  • Manuals and declarations kept consistent and versioned.
  • Pre-checked against what the buyer will audit.
For Builders
Industries

Built on pharma validation. Now running across regulated industries.

We started where the regulator is strictest. The same agents read the requirements and evidence of every regulated industry.

ImageReference deployment
URS-014OQ-11 · PASSSigned · Part 11

Life Sciences

CSV and equipment qualification, URS to PQ. Live inside a Global Top-10 pharma.

CSV/CQVURS→PQGAMP 5Annex 1121 CFR Part 11ALCOA+
Explore Life Sciences
Design input DI-22Verification VR-09Technical file §II

Medical Devices

Design inputs traced to verification. Technical files from your evidence.

ISO 13485EU MDRIEC 62304DHFTechnical file
Explore Medical Devices
HLR-118Test case TC-4471Compliance matrix CS-25

Aerospace

Every certification requirement traced to a verified test.

DO-178CDO-254AS/EN 9100Part 21 / 145
Explore Aerospace
Logbook 1998–2026Form 8130-3AD 2019-14-07 · gap

Aviation

Aircraft records checked for pre-buy and sale readiness.

LogbooksADs / SBsBack-to-birthPre-buy
Explore Aviation
RFP clause 7.3.2Vendor responseAcceptance test AT-31

Telecom

Vendor tenders and network acceptance, clause by clause.

Compliance matricesNetwork acceptanceProcurement
Explore Telecom
Tender item 4.12DoP · EN 13241Handover file

Construction & Infrastructure

Tender compliance, CE/EN conformity and handover files.

Tender complianceCE / ENCPRHandover
Explore Construction
Customer URS §5FAT protocol FP-02EU DoC

Industrial Machinery / OEMs

FAT/SAT, IQ/OQ packs and conformity files from your data.

FAT/SATIQ/OQManualsMachinery Regulation
Explore Industrial OEMs
 Any regulated industry

Same engine, your requirements.

Requirements on one side, evidence on the other? Your AI CQO can check it.

Tell us about your project
Trust

Four things we will not compromise on.

Learned inside pharma validation, where a missing signature is a finding and a drifting matrix is a warning letter.

Traceability

Trace graphs, not trace matrices.

Every requirement, piece of evidence, test and signature is a linked record, not a row in a spreadsheet.

Asked for the proof behind REQ-057, you answer in two clicks.
Human authority

Agents prepare. Humans sign.

Agents never decide or approve. A qualified person on your side reviews and signs every regulated output.

Your approval process stays exactly as it is. The typing disappears.
Data sovereignty

Your perimeter. Your models.

Single-tenant, deployed inside your environment. Any LLM. EU, US or UAE residency. Air-gap capable.

Zero training rights. Zero retention. Customer-managed keys.
Continuous assurance

100% reviewed. Not sampled.

Every requirement and every record is checked, every cycle, not the 1–5% a human team has time for.

The coverage auditors expect, at a pace people cannot sustain.
Standards we work toGAMP 5EU Annex 1121 CFR Part 11ALCOA+ISO 13485EU MDRDO-178CAS/EN 9100ISO 27001
Your AI CQO prepares. Your qualified person signs.Always
Free gap report

Hire your AI CQO for one job. Free.

Send one requirement document and one piece of evidence. The same agents that run inside a Global Top-10 pharmaceutical manufacturer find every gap and tell you what it would mean at audit. You get the report in 48 hours.

48 hFrom receiving your files to the report in your inbox
€0€2,500Free for your first document pair
2 filesOne requirement, one piece of evidence
NDA from our sideData deleted after deliveryNo login, no call required

Request your gap report

Upload now, or email both files to gapcheck@qualitum.ai.

Equipment supplier? Send a customer URS instead →

Prefer the NDA in place before anything leaves your building? Send the email first and we will countersign it ahead.

Received.

We will send our NDA today and your report within 48 hours of receiving both files.

FAQ

Short answers.

Each agent page has its own FAQ. The full pharma FAQ is on Life Sciences.

What is an AI Chief Quality Officer?

A team of AI agents that does the reading, comparing, gap-finding and drafting work of a quality department, 24/7. Every answer is traced to the page that proves it. Your AI CQO prepares. Your qualified person signs.

Does the AI approve or sign anything?

No. Agents prepare and check. A qualified person on your side reviews, approves and signs every regulated output with an attributable e-signature. The Verifier Agent re-checks drafts before a person sees them, but the decision is always human.

How is this different from ChatGPT or Copilot?

A general chatbot gives you an answer. Qualitum checks every requirement one by one, against every document, and links each result to the page and clause that proves it. If there is no proof, it is a gap. Several models must agree before a result is shown.

Where does our data go?

Nowhere outside your perimeter. Qualitum runs single-tenant inside your cloud or on-prem, with EU, US or UAE residency and air-gap capability. You choose the model. We have no training rights and keep no data.

Which industries does it work in?

Any industry where requirements must be proven with evidence: life sciences, medical devices, aerospace, aviation, telecom, construction and industrial machinery. Our reference deployment is inside a Global Top-10 pharmaceutical manufacturer; the results we quote come from there.

What do we need to start?

Two documents for the free gap report. For a pilot: one project, one requirement set and its evidence, and one qualified reviewer. First agent in production in 8 to 12 weeks.

10+ quality agents, working 24/7. Send two documents and see what they find.

Get a free gap reportMeet the agents