SYSTEM / 01
Validate·AI
Agentic CQV - IQ, OQ, PQ, CSV. Protocols authored, traceability matrices generated, deviations triaged, inspection-ready evidence packs produced. GAMP 5 & 21 CFR Part 11.
Explore Validate·AI →The Trusted Agentic Enterprise Platform
World's top life science institutions and global companies trust Qualitum to optimize their work daily
Proven to deliver data integrity, efficiency, and value on a global scale.
Trusted by
Why Qualitum
Engineering trust into life-critical industries.
Digitalize any validation process in one platform, your way. Assure integrity, optimize efficiency, and be audit-ready.
Assure
integrity
Assure data integrity, traceability, and compliance across the entire validation lifecycle - with agents grounded in your SOPs.
One platform; Any Process - Automated
Digitalize any validation process your way in one easy-to-use, highly configurable no-code solution.
Validation Protocols
Agent running - 3 active
IQEquipment · FT-IR spectrometer
OQCSV · Laboratory data system
PQCommissioning · Cleanroom HVAC
DQAnalytical · HPLC system suitability
SYSTEM / 02
Source·AI
From intake to PO. Agents draft specifications, shortlist qualified suppliers, run compliant RFQs, and negotiate within your policy envelope. Source-to-contract collapsed by 4×.
Explore Source·AI →SYSTEM / 03
Tender·AI
A fully digital DPS under EU Directive 2014/24/EU. Continuous admission review, mini-competition orchestration, MEAT evaluation, and the audit trail supervisory bodies require.
Explore Tender·AI →Use Cases
Empowering regulated teams at every stage
Clinical, Quality, Manufacturing, Regulatory, and Procurement teams - one agentic layer, your systems of record.
CLINICAL
Accelerate clinical study startup and site readiness.
Your clinical teams spend weeks authoring TMF documents, site qualification packages, and investigator-site validation records. Qualitum handles the document layer so your team focuses on the science.
Use cases
- Trial master file drafted against your TMF reference model
- Site qualification and essential document checks - continuous
- Clinical system validation (EDC, CTMS, eTMF) as a repeatable pack
- Integrations with Veeva Vault Clinical, Medidata Rave, Oracle
QUALITY
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.
Use cases
- Deviation intake, triage, and draft CAPA within minutes
- Periodic product review (PPR) dossiers auto-assembled
- Supplier quality audits and follow-ups orchestrated end-to-end
- Connects to Veeva QualityDocs, MasterControl, TrackWise, ETQ
MANUFACTURING
Faster facility startup and lifecycle qualification.
From greenfield commissioning to periodic requalification of clean utilities, HVAC, and critical equipment - agent-authored, engineer-reviewed, audit-ready.
Use cases
- IQ / OQ / PQ from P&ID and URS in hours, not weeks
- Clean utility qualification (WFI, PW, Pure Steam) fully templated
- Thermal mapping design, analysis, and reporting in one workflow
- CIP / SIP cycle qualification with sampling plan generation
REGULATORY
Submission-ready dossiers 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.
Use cases
- Global registration tracking with variation triggers
- eCTD component assembly and cross-reference validation
- Commitment tracking across FDA, EMA, PMDA, and emerging markets
- Handoff to Veeva RIM, ArisGlobal LifeSphere, Lorenz docuBridge
SAFETY & PHARMACOVIGILANCE
Never miss an ICSR. Never miss a timeline.
Case intake, MedDRA coding, narrative drafting, and aggregate report assembly - handled continuously by agents under your PV procedures. Your safety team focuses on medical judgment, not document wrangling.
Use cases
- ICSR intake from any channel with auto-triaged seriousness
- MedDRA coding and narrative drafting, reviewer-assistive
- PSUR / PBRER / DSUR sections assembled from the safety database
- E2B(R3) ready for Argus, ArisGlobal, and gateway submission
COMMERCIAL & MEDICAL AFFAIRS
Faster medical content. Same level of scrutiny.
From promotional materials to medical information responses, agents draft against your claims library and reference sources - with a defensible evidence trail for MLR review.
Use cases
- Promotional claims drafted against your reference library
- MLR-ready packages with linked citations and approval trail
- Standard response letters auto-drafted from the medical library
- Works alongside Veeva PromoMats, Vault MedComms, Aprimo
PROCUREMENT
Rationalise tail-spend. Compete every category.
The categories procurement never has time for - now run continuously by agents within your policy envelope. Savings appear. Maverick spend disappears.
Use cases
- Structured intake with threshold-based controls
- Supplier discovery, qualification, and risk screening
- RFQ orchestration with normalised evaluation matrices
- Integrations with SAP Ariba, Coupa, Oracle Fusion, Ivalua
PUBLIC SECTOR
Dynamic Purchasing Systems that actually run.
For contracting authorities: an end-to-end DPS that meets EU Directive 2014/24/EU to the letter. Admissions on time. Mini-competitions run properly. Defensible on review.
Use cases
- Contract notices with correct CPV codes and OJEU structure
- ESPD handling, exclusion checks, and selection criteria
- MEAT evaluation with transparent weightings and sign-off
- Full audit trail ready for oversight bodies and review
More ways teams use Qualitum
USE CASE
Equipment validation
Ensure equipment is validated, tested, documented, and maintained to meet operational and regulatory requirements - assuring consistent and efficient performance.
See use case
USE CASE
Computer system validation (CSV)
Ensure computer systems are validated, tested, and maintained in compliance with requirements - guaranteeing efficiency and effectiveness throughout their lifecycle.
See use case
USE CASE
Commissioning & qualification
Ensure facilities, systems, and equipment are designed, installed, tested, and operated per requirements - as efficiently as possible.
See use case
USE CASE
Analytical instrument validation
Ensure analytical instruments are qualified, calibrated, and maintained to provide accurate, reliable, and traceable results.
See use case
USE CASE
Audit readiness
Maintain a state of continuous compliance and documentation accuracy to ensure preparedness for regulatory inspections and all forms of audits.
See use case
Where we differ
Digital was the last decade. Agentic is this one.
Legacy 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?
| Capability | Legacy digital validation | Agentic & Automated |
|---|---|---|
| Core operating model | Humans author documents in a validated digital environment | Agents author and execute. Humans review, approve, and intervene by exception. |
| Protocol authoring | Template library; manual content creation with structured fields | Agent-authored IQ / OQ / PQ from URS, P&ID, and your SOP library |
| Deviation triage | Captured and routed; triage performed by a human reviewer | Agent triages, proposes root cause, and drafts CAPA; human approves |
| RTM generation | Manual linking between URS, FS, DS, and test cases | Continuously maintained trace graph; no orphan requirements |
| Procurement & DPS | Not in scope | Native agentic systems for procurement and EU-compliant DPS |
| Deployment model | Multi-tenant SaaS | Private deployment; your tenant, your models, your data perimeter |
| Time-to-value | 6–12 months for enterprise rollout | First audited agent in production within 8–12 weeks |
Measured against the legacy baseline.
Results from production.
70%
Reduction in validation document authoring time across IQ/OQ/PQ protocols.
4×
Faster supplier pre-qualification cycles versus traditional procurement tooling.
12wk
From kickoff to first audited agent running in your GxP environment.
Your data never leaves your perimeter.
ISO 27001
SOC 2 II
GDPR
21 CFR Part 11
04 - Private AI. Enterprise-grade.
Built for your security envelope
Qualitum deploys as a private tenant - your VPC, your region, your models. No training on your data. No shared inference pool. The agents run inside the security envelope your InfoSec team already controls.
DEPLOYMENT
Private tenant
Single-tenant VPC on AWS, Azure, or on-prem. EU, US, or UAE data residency.
MODELS
Frontier or local
Claude, GPT, Gemini, Llama, or your in-house fine-tunes. Swap per workflow.
DATA POSTURE
Zero-retention
No vendor training rights. No logging of prompt content. Full DPA.
CERTIFICATIONS
ISO 27001 · SOC 2 II
Annex 11 and 21 CFR Part 11 aligned. GDPR by design. EU AI Act documented.
ACCESS
SSO & RBAC
Okta, Entra ID, Ping. Fine-grained permissions to agent and action scope.
AUDITABILITY
Tamper-evident
Every agent action logged with immutable timestamps and attributable signatures.
Integrations
Compatible with the systems that already run your enterprise
Validation
Kneat Gx
Bi-directional connector. Qualitum authors, Kneat archives - or archive agent outputs as validated records.
QMS / eQMS
Veeva Vault Quality
QualityDocs, QMS, Training. Live handoff of agent-authored content into your Vault tenant.
QMS / eQMS
MasterControl
Documents, processes, and training events synchronised with agent actions.
QMS / eQMS
Sparta TrackWise
Deviation, CAPA, and change control handoff via validated connector.
ERP
SAP S/4HANA
Master data, materials, and PO generation through certified integration.
ERP
Oracle Fusion
Financial and procurement record-of-truth integration with full lineage.
Procurement
SAP Ariba · Coupa
Source-to-pay platforms. RFQ orchestration, contract handoff, PO flip.
Clinical
Veeva Vault Clinical
eTMF, CTMS, and Study Startup integrated for agent-assisted site readiness.
Regulatory
Veeva RIM · ArisGlobal
Registrations, submissions, and commitment tracking with regulatory systems.
MES
Werum PAS-X · Rockwell
Manufacturing execution systems for batch record and equipment data.
Identity
Okta · Entra ID
Enterprise SSO, SCIM provisioning, and role-based agent permissions.
Collaboration
Microsoft 365 · Google
SharePoint, OneDrive, Teams, Gmail, Drive - agents read and write natively.
The evidence package is what makes this real. It's not a demo with a model in it - it's a system we can hand to an auditor and defend. That is the difference.
Head of Quality Engineering
Global Top-10 Pharmaceutical Manufacturer
Built for regulation
The forcing functions are already on the calendar
Qualitum is architected around the regulatory regimes shaping the next decade of GxP and public procurement.
GAMP 5 / ANNEX 11
Computerised System Validation
Risk-based validation for AI-enabled systems in GxP environments. Agent outputs traced to specification and test.
21 CFR PART 11
Electronic Records & Signatures
Tamper-evident records, attributable signatures, and the full audit trail regulators expect.
EU AI ACT
High-Risk AI Systems
Transparency, human oversight, risk management, and post-market monitoring engineered into every deployment.
DIRECTIVE 2014/24/EU
Public Procurement · DPS
Structured dynamic purchasing systems, lawful and defensible for contracting authorities across the EU.