AudRI for GxP/a vertical of the AudRI compliance platform

GxP audits,
reduced 85–90%.

AudRI automates Computer System Validation periodic reviews for life sciences. Ingest SOPs and validation packages. Extract rules. Match evidence. Generate inspection-ready findings — in hours, not weeks.

See how it works

Demo is read-only — browse audits, findings and the tour without signing up. Ready for a pilot? Book a 30-min walkthrough.

21 CFR Part 11 · GAMP 5 · Annex 11 · ALCOA+

Periodic Review · LIMS-PROD-01LIVE

Compliance

89.4%

Rules

Findings

Critical

Time saved

112h

120h

Manual audit · per system

4–8h

With AudRI · per system

$14.8M

Avg cost of a single GxP consent decree

100%

Traceability · rule → test → evidence

01 · Capabilities

A purpose-built audit engine for regulated systems.

AudRI replaces the most painful, error-prone phases of CSV periodic review: rule extraction, evidence matching, and findings authoring. Every output is inspection-ready and fully traceable.

F.01

SOP rule extraction

Parse unstructured SOPs. Extract atomic, testable compliance rules with section references. Claude Haiku 4.5 in the loop.

F.02

Evidence ingestion

Upload URS, IQ, OQ, PQ, change controls, deviations. AudRI normalizes and indexes every artifact.

F.03

Semantic matching

Map rules → requirements → test cases → evidence. PASS / CONDITIONAL / FAIL verdicts with reasoning for every link.

F.04

Traceability matrix

Auto-built, coverage-scored, gap-highlighted. Replace spreadsheet archaeology with a living matrix.

F.05

Findings & CAPA

Findings classified Critical / Major / Minor / Observation with AI-authored corrective and preventive actions.

F.06

Inspection-ready reports

Periodic review reports that double as FDA 483 / Annex 11 inspection packs. One click to export.

02 · Workflow

From SOP to signed-off audit in four steps.

STEP 01

Add your GxP system — LIMS, MES, EDMS, SCADA, ERP-GxP. Risk level, owner, department.

STEP 02

Ingest documents

Drop in SOPs, URS, IQ/OQ/PQ, change controls, deviations. PDF, DOCX, TXT.

STEP 03

Run AudRI

The engine extracts rules, matches evidence, scores coverage and authors findings.

STEP 04

Review & export

QA reviews, adjusts severity, approves. Export inspection-ready PDF / push to DMS.

03 · Return

The math of manual audits is brutal.

A mid-sized biotech with 40 GxP systems running biennial periodic reviews spends ~3,200 QA hours every two years on paperwork — and still risks 483s from missed gaps.

Method

Hours / system

40 systems / 2 yrs

Fully manual

120 h

4,800 h

Spreadsheet-assisted

72 h

2,880 h

AudRI

6 h

240 h

04 · Compliance

Built for the way regulators read.

Every AudRI output maps to GAMP 5 categories, 21 CFR Part 11 audit-trail and e-signature controls, EU GMP Annex 11, ALCOA+ data-integrity principles and your internal QMS SOPs. Human-in-the-loop approval is preserved end-to-end.

21 CFR Part 11

GAMP 5

EU Annex 11

ALCOA+

Ready to audit faster

GxP audits,reduced 85–90%.