# Devia · Deviation Management Intelligence for Pharma

> Devia turns GMP deviations into operational intelligence: faster investigations, AI-assisted root cause, and audit-ready CAPA.

Source: https://devia.qa/

Deviation management intelligence

# Let’s end your recurring deviations forever.

Behind every deviation is a patient waiting for their medicine. Devia helps you capture, investigate and resolve variances quickly, turning quality events into insight so safe, effective therapies reach patients on time.

See how it works

- 01 It happens again

- 02 Devia checks every past record

- 03 It proposes the shared cause

- 04 Your QA decides

- 05 It stops coming back

Plugs into the systems your plant already runs. All integrations

Veeva Vault QMS

Honeywell TrackWise

MasterControl

Sparta

SAP S/4HANA

Oracle

Microsoft Dynamics 365

Sage X3

AVEVA PI

Snowflake

Google Cloud (GCP)

Databricks

NVIDIA

Anthropic

OpenAI

AMD

Siemens Opcenter

Körber PAS-X

Rockwell PharmaSuite

Emerson Syncade

LabWare

Thermo SampleManager

LabVantage

STARLIMS

01 Intelligence layer

## From intake to CAPA closure, in one validated flow.

- 01 Intelligent intake Deviations are captured from MES, LIMS and operator reports, then triaged by severity and similarity to past events.

- 02 Root cause analysis AI-assisted Ishikawa and 5-Why investigations drafted from batch records, equipment logs and historical deviations.

- 03 Audit-ready CAPA Corrective actions tracked to effectiveness checks, with a 21 CFR Part 11 and EU Annex 11 compliant audit trail.

02 Reinforcement learning

## Every deviation you close makes Devia smarter.

Every expert decision reinforces Devia Intelligence.

Devia proposes, your QA approves: human sign-off stays mandatory on every GMP record.

The learning stays inside your organization: your records never train models for anyone else.

Devia Intelligence

keeps learning

+1 deviation

- 01 · Propose Proposes

- 02 · Review Experts decide

- 03 · Capture Remembers

- 04 · Learn Gets smarter

Flexible enterprise deployment

### Infrastructure that meets scaling needs.

Scale the architecture effortlessly, adapting to your deployment requirements.

Security-first

### Enterprise-grade protection for your most critical IP.

Leverage the technology trusted by organizations with the most stringent security requirements.

System integrations

### Connectors for streamlined workflows.

Integrate the platform with your existing tools to unlock value and eliminate data silos.

03 Performance

## Built for sterile and biologics manufacturing

- −42% Investigation cycle time Today With Devia

- 3× Faster backlog clearance Today With Devia

- 100% Part 11 audit trail

04 Industry report

## We interviewed 200+ quality managers across biopharma.

Discover how quality teams handle deviations today, where time is lost, and why leaders are moving from reacting to preventing.

05

## Who we serve

### Pharmaceutical Manufacturers

- DEV-2214 Fill-weight variance Line 04 Major Similar to DEV-2211 · 94%

- DEV-2219 Cold room excursion CR-04 Major Recurs: 3 earlier

- DEV-2216 Gowning step skipped Grade B entry Minor

### CDMOs

Contract Development and Manufacturing Organizations

- DEV-3112 pH drift, bioreactor BR-2 Client A Major Similar to DEV-3047 · 88%

- DEV-3118 Filter integrity failure Client C Critical Impact assessment drafted

- DEV-3115 Label reconciliation gap Client B Minor

### CROs

Contract Research Organizations and Laboratories

- OOS-0417 Assay out of specification Lot 24-0915 Phase I Linked to DEV-2187

- LIR-0221 Sample custody gap Freezer FZ-11 Minor Same freezer as DEV-1188

- OOT-0398 Stability trend, 12 months Study S-118 Review

## Behind every deviation is a patient waiting for their medicine.

See the platform