Data IntegrityIQ: Data integrity. Continuously assured.
Watches your GxP systems around the clock, captures tamper-proof evidence and uses AI to connect data-integrity signals across systems — so you find issues in minutes, not at the next inspection.
21 CFR Part 11 · EU GMP Annex 11 · GAMP 5 · ALCOA+
Periodic audit-trail review looks backwards — and only samples.
- Blind spots. Data-integrity risk hides in the gaps between systems and between reviews.
- Late discovery. Issues surface during an FDA or EU inspection — the most expensive moment possible.
- Rising expectations. Regulators expect Part 11, Annex 11, GAMP 5 and ALCOA+ compliance to be demonstrable, not assumed.
- Manual burden. Quality teams spend days assembling evidence by hand for every audit.
What Data IntegrityIQ does
Continuous oversight
24/7 monitoring of user and system activity across your GxP applications — not a quarterly sample.
Immutable evidence
Raw audit trails are preserved in tamper-proof, write-once storage before they are parsed, with timestamps and checksums.
AI detection & correlation
Analytics flag anomalies and connect patterns that span LIMS, MES and eQMS — patterns no single audit trail shows.
Human quality review
Your experts assess each finding, decide and e-sign. AI assists and prioritises; it never makes the regulated decision.
Four steps from signal to evidence
Ingest
Read-only collection of audit trails and system activity, normalised into one model.
Detect
Rules and AI correlation score findings critical, high, medium or low.
Review
Findings route to your quality team for investigation, decision and e-signature.
Prove
Inspection-ready evidence packages on demand. Source systems remain the system of record.
Built for regulated teams
- Pharma, biotech and medical device manufacturers
- CDMOs, contract labs and testing facilities
- Heads of QA, Data Integrity leads, CSV/CSA managers and IT Quality owners
- Teams facing a recent 483, an upcoming inspection, a new system go-live or an audit-trail review backlog
Deployment
Self-hosted and read-only, deployed inside your own AWS account (Azure and GCP available). No shared data plane between customers and full data sovereignty — it never writes back to your validated systems.
Common questions
Will it change my validated systems?
No. Ingestion is read-only. Data IntegrityIQ never touches or changes your source data, and your systems remain the system of record.
Can an AI make GxP decisions?
No. AI only detects and prioritises. Your quality experts review, decide and e-sign every regulated decision.
Where does our data go?
It stays in your own cloud account, encrypted, with write-once evidence storage and multi-zone availability.
How is this different from a SIEM or BI tool?
It is purpose-built for GxP inspection readiness: findings are mapped to ALCOA+ and Part 11 / Annex 11 expectations and packaged as evidence an inspector can follow.
See Data IntegrityIQ in a live 30-minute demo
Bring your questions — we'll show you how it works in a GxP environment like yours.
Also from Adept LSS: ComplyIQ Pro — gxp training & competency and Driftly — gxp cloud compliance.