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Deviation Investigation · DV-0088
3 sourcesRecorded
You

Which batches used feed lot 2231-B, and how did their harvest titer compare?

Katalyze

Three batches used feed lot 2231-B: BR-0412, BR-0415 and BR-0421. BR-0412 and BR-0421 recorded lower harvest titer than the other batches in the set; BR-0415 was comparable.

The feeding records for BR-0412 and BR-0421 show a feed addition later than the master batch record planned; BR-0415 was fed as planned.

DV-0088 is open on BR-0412. The composition data for lot 2231-B is not in the review set.

Ask a follow-up, or open the execution record
SourcesSource-linked
  1. BR-0412 · harvest titer · lower

    BR-0415 · harvest titer · comparable

    BR-0421 · harvest titer · lower

  2. Feed 3 · recorded 11:40 · planned 09:00

    Margin note · feed 3 added late, see DV-0088

  3. DV-0088 · open · BR-0412

    Lot 2231-B · composition data

    Review set · not included

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Outcomes
  • 10M
    Doses delivered with Katalyze
  • 40%
    Faster batch release
  • Up to 8%
    Higher yield
  • 50%
    Deviation investigations, in half
  • Up 25%
    Plant throughput
  • 2 days
    An analysis that took a year and $1.5-3M
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Deviation Investigation · DV-0088
Open · draft 1
Possible explanations, in order4 sources · 12 batches
01
Feed timingFeeding records · BR-0412 · BR-0421
Investigate
02
Feed-lot variationMaterial record · lot 2231-B · BR-0412 · BR-0415 · BR-0421
Compare
03
Inoculum conditionSeed-train records
Review
04
Analytical contextHarvest results · sampling and method
Review
Draft investigation documentation, with the evidence and the proposed follow-up, for reviewReview
AI for GxP

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Say goodbye to year-long investigations, lost time to document search, and broken communication with other sites.

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Document Intelligence

Stop searching through batch records and COAs. Start asking them questions.

With Document Intelligence by Katalyze, paper batch records, COAs and PDFs, including records from suppliers, CROs, CDMOs and labs, become structured, source-linked data your teams can review, analyze and trust. Every value keeps its place on the page, from type to scribbled signature.

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An illustrative batch manufacturing record page, filled in by hand: a feeding record table, a corrected lot number, a margin note and a signature
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Document Intelligence · BR-0412
7 fields · 1 to review
FieldSource-linked
  • 1Batch numberBR-0412Extracted
  • 2Feed lot2231-B · corrected from 2231-AExtracted
  • 3Feed 3, recorded time11:40 · planned 09:00Extracted
  • 4Harvest sample to QC2026-03-16Extracted
  • 5Manufacturing reviewSigned · 2026-03-17Extracted
  • 6Margin notefeed 3 added late, see DV-0088Review
  • 7No further correctionsYes · box checkedExtracted
Structured record ready for the Context Layer; one field waits for a reviewerOpen record
  • Katalyze transformed our work by adding AI-powered insights to improve the yield. We can also identify root causes for deviations faster.Tara A · MSAT Data Science Manager
  • This platform feels like a tool designed for the next generation, offering instant access and connectivity for the SME community to manage raw materials effectively.Joana D · Critical Material Management
  • They had the security, the governance, the deployment story, everything we needed to scale this across R&D, not just run a pilot in one corner of the organization.Sabya D · Global Head (VP) R&D Data Platforms & Products
  • Katalyze has shortened the time required to provide insights that would have taken very long to arrive at or even conceptualize altogether.Andrew C · MSAT Process Lead - Tetanus USP
How Katalyze AI works

Source-grounded context. Governed results through proven workflows. Less wasted time and capital.

DOCUMENT INTELLIGENCEBatch recordsCertificates of analysisPDFsCONNECTORSSAPVeeva VaultPubMedContext LayerONTOLOGY · KNOWLEDGE GRAPHP-14Lot 2231-BCertificate 0091Feeding recordBR-0412DV-0088AGENTIC SOLUTIONSDeviationInvestigationDV-0088YieldOptimizationProduct P-14Raw MaterialCharacterizationCell-culture feedTechTransferSite A to Site BEXPERT REVIEWRUN RECORDEDJ. M. · MSAT leadApproval · execution record · audit trail
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Katalyze is built for regulated environments from the ground up: approved sources, within defined workflows, and records for every run, so a GxP team can verify what was done and why, and stay audit-ready.

How compliance works
Execution record · run 2026-03-18-0412Recorded
Execution recordsEach run is recorded and has an owner.
  1. 09:41:02Sources approved4 sourcesBatch records BR-0410 to BR-0421 · Veeva Vault · SAP · Snowflake
    Approved sourcesAgents are constrained to the right data and tools, and nothing else.
  2. 09:41:19Evidence assembledLineage kept12 batch records read, 3 systems queried, every value keeps its lineage
    Source lineageEvery result keeps its path back to the original record, table, field or note.
  3. 09:43:05Uncertainty surfaced1 flaggedComposition data for feed lot 2231-B is not in the review set; flagged, not assumed
    Uncertainty surfacedMissing or uncertain information is surfaced instead of passing silently.
  4. 09:44:40Draft preparedDraftInvestigation documentation: the possible explanations in order, the evidence behind each, the follow-up proposed
  5. 10:12:36ReviewedRevisedJ. M., MSAT lead · comment on explanation 02 · draft revised
    Expert approvalYour scientists retain review and approval authority over every decision.
Tara A, MSAT Data Science Manager

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
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