IntegrityIQ — Data Integrity. Continuously Assured.
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AI-Powered GxP Data Integrity Intelligence

Continuous GxP
Data Integrity Intelligence

IntegrityIQ transforms audit trails and system activity into trusted, inspection-ready evidence — with immutable storage, intelligent detection, and human quality review.

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Trusted across critical quality systems LIMSeQMSMES ELNERPCDS
The Platform

Four capabilities, one continuous assurance loop

IntegrityIQ continuously transforms GxP system activity into trusted, inspection-ready evidence — combining AI-powered detection with human quality review.

Continuous Oversight

24/7 monitoring across every system and user, so you stay ahead of risk instead of finding out at the next audit.

Immutable Evidence

Tamper-proof, time-stamped evidence, preserved before anything is parsed — trusted for any inspection.

AI Detection & Correlation

Intelligent analytics that surface issues faster and connect the dots across systems that single-system checks miss.

Human Quality Review

Expert review that applies context, experience, and quality judgment. AI assists — your people make every decision.

Why it matters

From raw system activity to confidence you can defend

Data integrity risk hides in the gaps between systems and audits. IntegrityIQ closes them, continuously.

Minutes, not the next audit

Monitor every GxP system and user around the clock, so anomalies and changes surface in minutes — long before an inspection would.

Inspection-ready by default

Every finding links back to tamper-proof, time-stamped evidence and a signed reviewer disposition — a package you can hand an inspector.

AI that connects the dots

Correlate activity across LIMS, eQMS, ERP and more to catch cross-system patterns — a changed result, a re-test, an approval with no deviation.

Your experts stay in control

AI is assistive only and never approves, rejects, or alters a record. Every regulated disposition is a human, attributable, electronically signed decision.

Deployment

Built for qualified AWS environments

IntegrityIQ deploys inside your own AWS account — your data never leaves your control. Validated, secure environments with encryption, immutable Object-Lock evidence storage, full auditability, and high availability.

ValidatedSecureCompliantScalable

Designed to support customer compliance with 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and ALCOA+. No shared data plane across customers.

Encrypted · Object-Lock evidence · Multi-AZ
Reference Architecture

Continuous data integrity, inside your own AWS account

From read-only ingestion to immutable evidence, AI-assisted detection and correlation, and human quality review — deployed entirely within your environment. IntegrityIQ reads data only and never writes back to your source systems.

IntegrityIQ reference architecture: GxP systems (LIMS, ELN, eQMS, ERP, MES, CDS) flow through read-only data ingestion into the IntegrityIQ platform running in the customer's AWS environment — immutable evidence store, audit-trail normalization, detection and correlation engine, AI analysis layer, case management and review workspace, and reporting and inspection evidence — feeding quality review and inspection readiness, with no write-back to source systems.
Deployed within your AWS account using your security, IAM, and network controls. Preserve first, analyze second — your source systems remain the systems of record.
Why IntegrityIQ

Purpose-built for regulated quality teams

Trusted & Inspection-Ready

Purpose-built for GxP compliance and regulatory confidence.

Precise & Actionable

Pinpoints risk with precision so your teams can act with confidence.

Intelligent & Proactive

AI-powered detection finds issues you didn't know to look for.

Secure & Immutable

Immutable storage and end-to-end security protect what matters.

FAQ

Answers for quality & compliance teams

The questions we hear most from Directors of Quality, Compliance, and Validation.

What is IntegrityIQ?+
IntegrityIQ is an AI-powered GxP data-integrity intelligence platform. It continuously turns the audit trails and activity from your regulated systems into trusted, inspection-ready evidence — automatically surfacing data-integrity issues for your quality team to review, decide, and sign off.
Does our data ever leave our environment?+
No. IntegrityIQ deploys inside your own AWS account and processes data there, under your KMS keys and network controls. Your regulated data is never pooled with, or exposed to, other organizations — there is no shared SaaS data plane.
Is it read-only? Can it change our source data?+
It is read-only by design and never writes back to your source systems. Original evidence is stored immutably (write-once, tamper-evident) and can never be altered — by the platform, the AI, or a user. Preserve first, analyze second.
Does IntegrityIQ make us 21 CFR Part 11 / Annex 11 compliant?+
No tool can do that on its own — be cautious of any that claims to. IntegrityIQ is designed to support your compliance program with capabilities aligned to 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and ALCOA+ (immutable evidence, tamper-evident audit chains, e-signatures, full traceability). Your processes and people complete the picture.
How is AI used — does it make decisions?+
AI is strictly assistive. It helps summarize and prioritize, but it never approves, rejects, or alters a record, and its output is clearly labeled “AI-generated — not source evidence.” Every regulated disposition is made by a qualified human and electronically signed.
What kinds of data-integrity issues can it catch?+
Examples include a result changed after approval, the same person modifying and approving a record, an audit trail being disabled, privilege escalation, changes with no reason recorded, repeated reprocessing, statistical outliers, off-hours activity, and a result changed then approved with no linked deviation.
Do you need our vendor’s SDK to connect a system?+
Usually not. Most systems integrate via read-only database access, scheduled exports, or existing APIs — no vendor SDK required. Deeper native integrations are scoped individually, and where a vendor’s API access is needed, we help you arrange it.
How does it help during an inspection?+
Every finding links to tamper-proof, time-stamped original evidence and a signed reviewer disposition, exportable as a single sealed evidence package — so you hand an investigator a complete record instead of assembling one under pressure.
Is IntegrityIQ a replacement for our LIMS, eQMS, or CDS?+
No. Your systems remain the systems of record. IntegrityIQ sits alongside them as an independent, read-only layer of oversight and evidence — it never replaces or writes back to them.
How do we get started?+
With a 30-minute scoping call and a pilot on one or two of your systems, so you can see IntegrityIQ surface real findings in your own data before scaling. Use “Book a Demo” to begin.

More questions? Talk to our team →

See IntegrityIQ on a real GxP scenario

Book a 30-minute demo. We'll walk continuous data integrity assurance end to end — from immutable evidence to a signed, inspection-ready package — and answer how it fits your systems.

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demo@dataintegrityiq.com · Deployed in your AWS environment · Data Integrity. Continuously Assured.