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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

01Intelligence layer

From intake to CAPA closure, in one guided flow.

  1. 01

    Devia asks for what your procedure requires and reads the photos and PDFs attached, then triages each report by severity and similarity to past events.

  2. 02

    AI-drafted Ishikawa and 5-Why analyses, built from the report, your SOPs and the past deviations most like it. Your team confirms the cause.

  3. 03

    Corrective actions recommended for the confirmed cause and tracked to closure, with an audit trail that supports 21 CFR Part 11 and EU Annex 11.

02Precedent

Every deviation you close becomes precedent.

Every expert decision becomes the next case’s starting point.

Devia proposes, your QA decides: every root cause, recurrence verdict and closure is a person’s call.

Your records stay inside your organization and never train models for anyone else.

Your precedent

grows with every case

+1 deviation

  1. 01 · ProposeDevia drafts
  2. 02 · ReviewExperts decide
  3. 03 · KeepRemembers
  4. 04 · RecallFinds it again
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.Your QMS

Works with the records you already keep.

Your deviation history is imported from your QMS, and every closed deviation comes out as a report in its format.

03Performance

Built for sterile and biologics manufacturing

  • −42% Investigation cycle time

  • 3× Faster backlog clearance

  • 100% Decisions recorded

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-2036Fill-weight varianceLine 04MajorSimilar to DEV-1884 · 94%
  • DEV-2041Cold room excursionCR-04MajorRecurs: 3 earlier
  • DEV-2039Gowning step skippedGrade B entryMajor

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 BMajor

CROs

Contract Research Organizations and Laboratories

  • DEV-4417Assay run outside its method windowLot 26-0388MajorSimilar to DEV-4380 · 86%
  • DEV-4421Sample custody gapFreezer FZ-11MinorSame freezer as DEV-1188
  • DEV-4425Stability pull missedStudy S-118Minor

Behind every deviation is a patient waiting for their medicine.

See the platform