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Deviation management intelligence

Let’s end yourrecurring deviationsforever.

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

Plugs into the systems your plant already runs. All integrations

01Intelligence layer

From intake to CAPA closure, in one validated flow.

  1. 01

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

  2. 02

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

  3. 03

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

02Reinforcement 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

  1. 01 · ProposeProposes
  2. 02 · ReviewExperts decide
  3. 03 · CaptureRemembers
  4. 04 · LearnGets smarter

03Performance

Built for sterile and biologics manufacturing

  • −42% Investigation cycle time

  • 3× Faster backlog clearance

  • 100% Part 11 audit trail

04Industry 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-2214Fill-weight varianceLine 04MajorSimilar to DEV-2211 · 94%
  • DEV-2219Cold room excursionCR-04MajorRecurs: 3 earlier
  • DEV-2216Gowning step skippedGrade B entryMinor

CDMOs

Contract Development and Manufacturing Organizations

  • DEV-3112pH drift, bioreactor BR-2Client AMajorSimilar to DEV-3047 · 88%
  • DEV-3118Filter integrity failureClient CCriticalImpact assessment drafted
  • DEV-3115Label reconciliation gapClient BMinor

CROs

Contract Research Organizations and Laboratories

  • OOS-0417Assay out of specificationLot 24-0915Phase ILinked to DEV-2187
  • LIR-0221Sample custody gapFreezer FZ-11MinorSame freezer as DEV-1188
  • OOT-0398Stability trend, 12 monthsStudy S-118Review

Behind every deviation is a patient waiting for their medicine.

See the platform