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SolutionsDeviation Investigation

Work through possible causes, with the evidence in view.

For Quality, MSAT, and manufacturing teams

Understanding a deviation can require evidence beyond the deviation record. Katalyze connects it, tests possible explanations, and drafts investigation documentation for experts to review.

Where the time goes

Getting the evidence together takes time.

Records sit across functions, systems, and partners. Experts have to find the relevant details and reconcile them before they can assess the question.

How Agentic Solutions work
Today
With Katalyze
  • Finding the relevant records
  • Reconciling the event history
  • Tracing possible explanations
  • Determining cause and response
How it works

From the first question to work your team can use.

Katalyze connects evidence, investigates the question, and drafts documents and action plans. Your experts guide the work and decide what follows.

Explore Document Intelligence
  1. 01

    Connect the evidence

    Bring the relevant batch records, process context, material history, and other available evidence together with source pointers.

    • Feeding recordBR-0412Document Intelligence
    • Deviation record DV-0088Veeva Vault
    • Lot 2231-Bcertificate 0091SAP
    • Harvest resultsBR-0410 to BR-0421Snowflake
    • Cell-culture media variabilityPubMed
  2. 02

    Test explanations

    Generate hypotheses and test them against the connected evidence, with missing information and uncertainty visible.

    1. H1Feed timinglater in BR-0412 and BR-0421 · investigate
    2. H2Feed lot 2231-Bshared with BR-0415 · compare
  3. 03

    Draft the documentation

    Draft investigation documentation with supporting evidence, open questions, and proposed follow-up for experts to review.

    Draft 1
    1. 01Possible explanations, in the order to investigate
    2. 02Findings, each with its source
    3. 03Proposed follow-up · draft 1
    every line cited · for review
Review the evidence

See what supports the finding.

Inspect the supporting records, challenge the interpretation, and see where information is missing. Your experts retain review and approval.

Explore GxP support
Investigation summary · DV-0088 · draft 1In review
  1. 01Possible explanations, in the order to investigate
    02 · Feed-lot variation

    Lot 2231-B is the cause of the lower harvest titer in BR-0412 and BR-0421.

    Lot 2231-B is shared by the two lower-titer batches, but the comparison does not establish a material cause. Feed timing also differs. Both remain under investigation.

    don't call the lot the cause. Compare feed timing across all three batches that used it.J. M. · MSAT lead
  2. 02Findings, each with its source
  3. 03Proposed follow-up · draft 1
Revised · 10:12:36run 2026-03-18-0412 · recorded · owner J. M. · 5 actions · 1 revision · 1 comment
Feed addition · recorded later than planned
  1. PageBatch record BR-0412 · Feeding record
  2. SourceDocument Intelligence · batch records, read from the page
Customer experience

Customer experience with deviation investigations.

Deviation investigations, in half
50%
Reduced root cause analysis for deviation caused by raw material
25%
An analysis that took a year and $1.5-3M
2 days

Katalyze transformed our work by adding AI-powered insights to improve the yield. We can also identify root causes for deviations faster.

Tara AMSAT Data Science Manager
Questions

Questions about Deviation Investigation.

What the work draws on, what your team receives, and how experts use it.

More questions and answers
Book a demo

Start with the question holding work up.

Bring the job you want to move forward and the records you'd like connected. Thirty minutes on how Katalyze would do the work, and where your experts come in.

Or, just a quick chat to run through the product, your call.