Skip to content
Katalyze announces $10.5M seed round. Read the press release
Book a Demo
SolutionsRaw Material Characterization

Investigate what material differences mean for your process.

For process, CMC, and Quality teams

A material can meet its specification and still deserve closer investigation. Katalyze connects material, supplier, and process evidence so experts can assess the differences that matter.

Book a DemoExplore the platform
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
  • Gathering material information
  • Reconciling supplier records
  • Tracing lots to process history
  • Judging the process relevance
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 material records

    Bring the available certificates of analysis, supplier information, and relevant scientific sources into context.

    • Certificate 0091lot 2231-BDocument Intelligence
    • Certificate 0088lot 2231-ADocument Intelligence
    • Material masterlots 2231-A, 2231-BSAP
    • Feeding recordsBR-0412 · BR-0415BR-0421
    • Cell-culture media variabilityPubMed
  2. 02

    Examine the differences

    Investigate material and supplier differences alongside the process and batch evidence relevant to the question.

    1. H1Lot 2231-B differs in compositionnot in the review set · request data
    2. H2The certificates explain the titernot established · compare
  3. 03

    Prepare the assessment

    Draft a material assessment with supporting evidence, unresolved questions, and proposed follow-up for experts to review.

    Draft 1
    1. 01Lots, certificates and the batches that used them
    2. 02What the certificates do and do not cover
    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
Material assessment · feed lots 2231-A and 2231-B · draft 1In review
  1. 01Lots, certificates and the batches that used them
    01 · Lot 2231-B

    Certificate 0091 shows lot 2231-B within specification, so the material is ruled out.

    Certificate 0091 covers the attributes it lists; the composition data relevant to process performance is not in the review set. Request it before ruling the lot in or out.

    a certificate on file does not cover every attribute that matters here.K. S. · Quality
  2. 02What the certificates do and do not cover
  3. 03Proposed follow-up · draft 1
Revisedrecorded, with its owner · 4 actions · 1 revision · 1 comment
Lot 2231-B · BR-0412 · BR-0415 · BR-0421
  1. PageMaterial record · lot 2231-B · usage
  2. SourceSAP · material master, read where it is
Customer experience

Katalyze in pharmaceutical operations.

See customer resultsBook a Demo
Reduced root cause analysis for deviation caused by raw material
25%
Deviation investigations, in half
50%
Increased productivity
30%

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 DCritical Material Management
What comes next

Build on the knowledge your team has already connected.

The same platform supports all four solutions. The Context Layer can be reused and expanded as your team takes on another operational question.

Explore all solutions
  1. 01

    Deviation Investigation

    Assemble and validate the evidence behind possible causes; your experts determine the cause and the response.

  2. 02

    Yield Optimization

    Connect recipes, process and material data to investigate yield; your experts decide what the findings mean.

  3. 03

    Tech Transfer

    Assemble process knowledge and evidence into transfer documentation and plans; your experts focus on the open questions.

Questions

Questions about Raw Material Characterization.

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.

All solutions