Audit Intelligence™ — Continuous Audit Readiness | Kintavo

MODULE 14 / 19

Audit Intelligence™

Surface compliance gaps before inspectors find them.

Continuous readiness scans against your frameworks — scored, prioritized, and turned into work before the audit notice arrives.

✓Readiness score ✓Framework mapping ✓Prioritized gaps ✓Continuous scans

See it in a demo ← All 19 modules

Audit Intelligence™ — connected records LIVE

SCAN-44 ISO 13485 readiness · 2 gaps open PASS

SCAN-45 CLIA scan · 2 low-priority gaps REVIEW

SCORE Readiness 96 · up 4 points this quarter TREND

EVID Evidence pack · 312 records indexed BUILT

THE PROBLEM

Every System Has an Audit Trail. Almost Nobody Reads It.

Part 11 made audit trails mandatory, so every system writes one — into a table nobody opens until a regulator asks. Meanwhile the trail quietly records the patterns that become findings: the review that always happens at 4:58 on Fridays, the corrections that cluster around one workstation, the record activity that stopped when it should not have.

FDA’s data integrity guidance expects audit trail review as a routine control. Done by hand, it is a soul-crushing task that gets skipped; skipped, it becomes the finding itself.

REGULATORY REQUIREMENTS

What Part 11 and Data Integrity Guidance Expect From Audit Trails

Part 11 requires secure, computer-generated, time-stamped audit trails that record operator entries and actions. FDA’s data integrity guidance goes further: audit trails subject to regular review, with attention to changes to critical data. ALCOA+ frames the standard — attributable, legible, contemporaneous, original, accurate — and the trail is where those properties are proven or broken.

A trail nobody reviews satisfies the letter and fails the intent. Kintavo reviews its own: baselines learned from your operation, deviations from pattern surfaced daily, and the review itself documented — closing the loop the guidance asks for.

WHAT AUDITORS WRITE UP

! Audit trail review procedures that exist on paper but produce no evidence of review.

! Batch-signed records — ten completions with timestamps seconds apart.

! Corrections and deletions clustering around one user, one station, one shift.

! Activity gaps in continuous processes — the silence that demands an explanation.

WHAT KINTAVO REPLACES

The old way, retired.

A trail nobody reads → A trail that analyzes itself and briefs the team

Manual trail review, skipped → Documented review of surfaced exceptions

Patterns found by inspectors → Patterns found by the platform, first

Data integrity as an assertion → ALCOA+ properties monitored continuously

Annual forensic panic → A daily brief, five minutes long

EVIDENCE, NOT CLAIMS

This is the actual screen.

Audit Intelligence™ in Kintavo — product screenshot

SHOWN WITH SAMPLE DATA

CORE CAPABILITIES

The Trail Reviews Itself. Your Team Reviews the Exceptions.

Activity Baselines

The platform learns your operation’s normal — by module, role, and time — so deviation from pattern is detectable, not anecdotal.

Anomaly Surfacing

Off-hours activity, correction clusters, batch-signing patterns, silent gaps — flagged daily with the records attached.

Trend Charts

Activity by day, module, and user — the drift that precedes findings, visible while it is still just drift.

Documented Review

Flagged items get dispositioned — expected, investigated, escalated — creating the review evidence the guidance expects.

Escalation Path

An anomaly worth investigating opens a deviation with the trail excerpt attached. No copy-paste forensics.

Inspector-Ready Export

Any slice of the trail — record, user, time window — exports in minutes, with the review history alongside.

IN PRACTICE

Tuesday’s brief flags two items. One is expected — month-end training completions. The other is not: QC corrections on one analyzer cluster on weekend shifts, eleven in three weeks. The quality manager escalates it to a deviation with the trail excerpt attached; the investigation finds a calibration drifting on Saturdays after a Friday power cycle. The pattern an inspector would have found in March was found — and fixed — in January.

NOT A SILO

Part of one connected system.

Audit Intelligence™ shares the same data model, AI engine, and audit trail as the other eighteen modules — so its records see, and are seen by, everything else in your quality system.

INTELLIGENCE AI Smart Assist™ Semantic search and gap detection across every record. Explore → INTELLIGENCE 360° Compliance Map™ See how every record connects to everything else. Explore → INTELLIGENCE Configurable Dashboard Your compliance picture. Real-time. All in one view. Explore →

COMMON QUESTIONS

Audit Intelligence FAQ

Does this satisfy audit trail review requirements?

It operationalizes them: exceptions are surfaced daily, each flag is dispositioned, and the review itself is documented — the evidence FDA’s data integrity guidance expects, produced as a byproduct of a five-minute brief.

What counts as an anomaly?

Deviation from your operation’s learned baseline: off-hours activity, correction clusters, batch-signing patterns, activity gaps. Thresholds are configurable, and every flag shows its underlying records.

Can flagged items become investigations?

Yes — one click opens a deviation with the trail excerpt attached, so escalation carries its evidence with it.

Can inspectors be given trail exports?

Any slice — by record, user, or time window — exports in minutes, alongside the documented review history. That combination is what turns a request into a non-event.

See Audit Intelligence™ run on your workflows.

Your audit trail already knows. Let it brief you.

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