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Katalyze for Quality Teams

Give reviewers a clear path from finding to evidence.

Reviewers need to see how a conclusion was reached. Katalyze connects the relevant records and helps prepare investigation documentation, so Quality can examine the reasoning, resolve open questions, and assess the proposed response.

Record review · deviation investigation · evidence traceabilityBR-0412 · DV-0088 · March 2026
  1. Feed addition · BR-0412 · Feeding recordrecorded later than planned · noted on DV-0088Batch record BR-0412 · Feeding recordFlaggedConfirmed · K. S. · 03-18
  2. Certificate 0091 · lot 2231-Bcomposition data not in the review set · requestedCertificate of analysis 0091 · K. S.In reviewOn file · covers the attributes it lists
  3. Certificate 0088 · lot 2231-ACertificate of analysis 0088In reviewOn file · comparison context
  4. DV-0088 · harvest titer lowerone explanation to investigate, one to compare, two to review · no disposition decided hereVeeva Vault · deviation recordOpenOpen · findings drafted for review
  5. Investigation summary · draft 1the lot is not called the causerun 2026-03-18-0412In reviewRevised · J. M. · 10:12:36

5 items · 4 decided · 1 open · document review, material status and batch disposition kept separate

The working week

Where your team's time goes.

Finding records, reconciling details, and writing up findings leave less time for the next technical question.

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March 2026Fri 20
Locating the supporting record
Reviewers need the relevant record and its context before they can assess a finding.
Reconciling conflicting details
An investigation can span records that describe the same event differently.
Checking the basis of a conclusion
The reviewer has to distinguish a supported finding from an assumption or an open question.
Deciding the quality response
Quality weighs the findings, resolves open questions, and determines the appropriate response.
Your systems

Put the knowledge in your systems to work.

Connect the information the job needs. Your existing systems remain the source of truth.

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Where to start

Where Katalyze can support your team.

Connect the knowledge each solution needs, then use it to investigate questions and prepare work for review.

Explore all solutions
  1. 01

    Deviation Investigation

    Review draft investigation documentation against the supporting evidence before deciding the conclusions and response.

    • DV-0088 · open on BR-0412
    • findings, each with its record
    • Revised · J. M. · 10:12:36
  2. 02

    Raw Material Characterization

    Examine certificates of analysis and material context when assessing a question about a lot or supplier.

    • lot 2231-B · certificate 0091 on file
    • composition data · not in the review set
    • K. S. · Quality · request the data
Who does what

Give your team time to work through the hard questions.

Katalyze investigates evidence and drafts documents. Your experts refine the work and decide what follows.

How Agentic Solutions work
  1. Your Quality team

    Your team sets the review scope

    Define the record set, investigation question, and responsibilities for review.

    BR-0412 · Feeding record · DV-0088
  2. Katalyze

    Katalyze assembles the evidence

    Connect the relevant records and extracted information with pointers back to their sources.

    18 fields · feeding record · placed, not re-keyed
  3. Katalyze

    Katalyze drafts the documentation

    Prepare investigation documentation with supporting evidence and unresolved questions for reviewers to assess.

    17 pass · 1 flagged
  4. Your Quality team

    Your reviewers assess the draft

    Check the draft against source evidence and assess whether the conclusions and proposed follow-up are supported.

    K. S. · confirmed against DV-0088
  5. Katalyze

    Katalyze supports the follow-up

    Prepare proposed action plans from the reviewed findings within the defined workflow and record the run.

    Investigation summary · draft 1
  6. Your Quality team

    Your team makes the quality decision

    Retain authority for approval, the investigation response, and decisions under your quality procedures.

    Revised · J. M. · run recorded
Customer experience

Customer results in batch release and investigations.

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
Faster batch release
40%
Deviation investigations, in half
50%
Reduced root cause analysis for deviation caused by raw material
25%
Questions

How Katalyze fits your team's work.

Explore the records, responsibilities, and review process behind the work.

More questions and answers
Book a demo

More time for the work that moves medicine.

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.