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Document Intelligence for Pharma

Stop searching through batch records and certificates of analysis. Start asking them questions.

Document Intelligence by Katalyze turns batch records, certificates of analysis, recipes and process records, lab reports, deviation records, SOPs and transfer documentation, on paper, in scans and in PDFs from your labs, suppliers, CROs and CDMOs, into structured, source-linked data your teams can review, analyze and trust.

Today

The records are there. Using the data still takes work.

Batch records, certificates of analysis, recipes, lab reports and deviation records hold the information your teams need, but understanding a complete record and its meaning still requires experts to find the relevant values, interpret the tables and notes, and transfer the information into another file or system.

Today, your experts
  • Find the values in a long record
  • Interpret the tables, symbols and notes
  • Re-key them into another file or system
With Document Intelligence
  • Every value is read into your schema, linked to its page
  • What it is unsure of is flagged for your experts
  • The data is ready for your systems and Agentic Solutions

Free your experts to advance the science.

See it work
Digitize and Connect Your Data

See a batch record become usable data.

On the left, the record as it arrived: printed form, handwritten values, a correction, a margin note, scribbles and checkmarks. On the right, the same page digitized into your schema: every value with what the form called it, where it was read and what still waits for review.

Ask your data a question
Document Intelligence · BR-0412page 6 of 12 · 18 fields · 1 for review
FieldRead fromValueState
Header
ProductProductp. 6 · headerP-14 mAb
Batch numberBatch No.p. 6 · headerBR-0412
BioreactorBioreactorp. 6 · header2000 L
Date startedDate startedp. 6 · header2026-03-02
Feeding record, section 6
Feed 1, recorded timeRecorded timep. 6 · step 6.1 · handwritten09:10 · planned 09:00
Feed lotFeed lotp. 6 · step 6.1 · corrected, AM 03-052231-B · corrected from 2231-A
Feed 2, recorded timeRecorded timep. 6 · step 6.2 · handwritten09:05 · planned 09:00
Feed 3, recorded timeRecorded timep. 6 · step 6.3 · handwritten11:40 · planned 09:00
Feeds 4 to 6, recorded timesRecorded timep. 6 · steps 6.4 to 6.6 · handwritten09:00 · 08:55 · 09:05 · planned 09:00
Feeds verifiedVerified by (initial / date)p. 6 · steps 6.1 to 6.6KS · every feed
Rows 6.7 to 6.8(rows crossed through)p. 6 · rows struck, KS 2026-03-16Not used
Harvest sample to QCHarvest sample to QC (date / initials)p. 6 · harvest line · handwritten2026-03-16 · AM
Titer resultTiter result: see Harvest results (analytical record)p. 6 · printed line under the harvest sampleSee Harvest results
Review
Deviation issuedDeviations issued against this recordp. 6 · deviations lineDV-0088 · AM 2026-03-07
Margin note(margin)p. 6 · margin, KS 2026-03-16feed 3 added late, see DV-0088Review
Manufacturing reviewManufacturing review complete (sign / date)p. 6 · review blockSigned · 2026-03-17
QA reviewQA review (initial / date)p. 6 · review blockKS · 2026-03-18
No further correctionsNo further corrections on this page.p. 6 · footer, KS 03-18Yes · box checked
An illustrative batch manufacturing record page, filled in by hand: a feeding record table, a corrected lot number, a margin note and a signature
page 6 of 12 · 18 fields · 1 flagged for review
The questions

Ask your data a question. The answer is sourced and connected thanks to Document Intelligence.

Once the records are data, your teams ask Katalyze questions in plain language. An answer can draw on several records at once, and it cites each one it was read from, so an expert can check it against the page.

Book a Demo
Ask Katalyze · P-14Answered
Question

Which P-14 batches recorded a feed addition later than planned, and how did their harvest titer compare?

Answer

Two of the twelve in the comparison set: BR-0412 and BR-0421. On both, the feeding record shows feed 3 recorded later than the master batch record planned; on BR-0412 at 11:40 against 09:00, with a margin note referring the late addition to DV-0088.01

Both recorded lower harvest titer than the other batches in the set. BR-0415, fed as planned, was comparable.02

All three used feed lot 2231-B, under certificate 0091. The comparison does not separate feed timing from the lot.03

Follow-upWhat does DV-0088 record so far, and is it still open?

The workflow

How it works: contextualized data extraction.

A workflow made from reusable extraction, assembly, rules, review and egress steps, built from scratch for the pharmaceutical manufacturing industry.

Explore the Context Layer
01 · ExtractBatch record BR-0412 · p. 6
02 · AssembleIn your schema
03 · Check5 rules · 1 for review
04 · ReviewFlagged · beside its page
05 · Deliver5 fields · source-linked
010203
  1. 01Feed lot2231-B, correctedfeeding record
  2. 02Feed 3, recorded11:40feeding record
  3. 03Margin notefeed 3 added late, see DV-0088page margin
  • Batch recordBR-0412 · 12 pages
  • Certificate of analysislot 2231-B · PDF
  • Master batch recordP-14 · Rev 3 · PDF
FieldValueRead from
Feed lot2231-B, correctedfeeding record
Feed 3, recorded11:40feeding record
Margin notefeed 3 added late, see DV-0088page margin
Certificate0091certificate header
Feed 3, planned09:00master batch record
FieldValueRuleState
Feed lot2231-B, correctedLot on record
Feed 3, recorded11:40Deviation if late
Margin notefeed 3 added late, see DV-0088Refers to a deviationReview
Certificate0091On file for the lot
Feed 3, planned09:00Current revision
Margin notefeed 3 added late, see DV-0088page marginReview
KS · 2026-03-18Checked against DV-0088, still openConfirmed
FieldValueRead fromState
Feed lot2231-B, correctedfeeding record
Feed 3, recorded11:40feeding record
Margin notefeed 3 added late, see DV-0088page marginConfirmed
Certificate0091certificate header
Feed 3, planned09:00master batch record
  1. Context Layerwith the data from your systems
  2. Deviation Investigation · DV-0088
  3. Yield Optimization
  4. Your systems
Document intelligence for pharma

Designed for pharmaceutical records.

Work with long, complex documents containing tables, diagrams, scientific notation, handwriting and inconsistent formats. Batch records and certificates of analysis are where teams commonly begin; within an Agentic Solution the document set is selected for the job.

Book a Demo
Batch manufacturing record1 / 1HeaderProcess tableMargin noteDeviationsReview and signatures

Batch record

The executed record of one batch: printed forms filled in by hand across dozens of pages, with corrections struck once and initialed, notes in the margin and a signature on every review.

What is read
  • Header fields
  • Process tables
  • Hold times
  • Yields
  • Corrections
  • Margin notes
  • Signatures
FeedsDeviation Investigation · Yield Optimization
Explore batch records
Built for GxP environments

Traceable by design.

Document Intelligence by Katalyze works within your organization's validation and approval framework: extracted information stays linked to the original page, flagged exceptions go to your experts before anything moves downstream, and every run is recorded. Nothing is re-keyed by hand, nothing uncertain is filled in, and nothing flagged moves on without a person. Built for GxP environments and processes.

How compliance works
Document run · BR-0412 · 2026-03-1806 Documented processing
Recorded
09:12:0409:12:3109:12:4009:58:1209:58:30
  1. 12 pages readBatch record BR-0412, a paper scan: 18 fields, 1 table, 2 corrections and 1 margin note, each keeping the page and the region it was read from12 pages
    01 Source-linked dataInspect the original evidence behind extracted information.
  2. Placed, not re-keyedEvery value in the field your operation defined for it, from the page rather than a keyboard; the corrected feed lot and one deviation reference resolvedYour schema
    02 Customer-defined schemasInformation organized around the terminology, document structures and field definitions your operation uses.
  3. Unsure, so flagged17 values pass their rules; the margin note, which the read is unsure of, is flagged instead of filled in1 flagged
    03 Uncertainty surfacedMissing or uncertain information is surfaced instead of passing silently.
  4. A person decidesKS checks the flagged note against DV-0088 and confirms the read; the decision is recorded with the time and the initials, and the deviation stays openConfirmed
    04 Expert controlReview extracted information and flagged exceptions before it moves downstream.
  5. Lineage keptThe reviewed record reaches the Context Layer with every value's source and every decision, inside your validation and approval frameworkDelivered
    05 Designed for validated processesGoverned outputs used within your organization's validation and approval framework.
Where the data goes

Connect the records to the rest of your operation.

Agentic Solutions use this source-grounded context to establish ground truth, investigate with evidence and execute governed work. Start with the documents and data needed for the first operational job; the same Context Layer can be reused and expanded as additional solutions are introduced.

All Agentic Solutions
  1. 01
    Agentic Solution

    Deviation Investigation

    Assemble and validate relevant evidence to investigate possible causes.

    Explore Deviation Investigation
  2. 02
    Agentic Solution

    Yield Optimization

    Connect recipes, process records, material data and system data to investigate yield performance.

    Explore Yield Optimization
  3. 03
    Agentic Solution

    Raw Material Characterization

    Connect material, supplier and scientific information to investigate variability.

    Explore Raw Material Characterization
  4. 04
    Agentic Solution

    Tech Transfer

    Assemble process knowledge and supporting evidence to prepare transfer documentation and action plans.

    Explore Tech Transfer
In practice

Scientists and engineers use Katalyze to investigate, improve and advance.

What teams started with, what their records became and what changed for the scientists and engineers who use them.

See customer results
Cell therapy developer

Batch record review went from days to hours.

A cell therapy developer started with paper batch records and certificates of analysis from three suppliers. The records became source-linked data in its own schema, and deviation investigations now start from the data, not from the binder.

See customer results
Every value we used to re-key by hand is read from the page with its source beside it. Our scientists spend the time on the science instead.
Head of MSATCell therapy developer
80%less time re-keying batch records
Hoursto review a batch record, from days
Contract manufacturer

Certificates of analysis from forty suppliers, one schema.

A contract manufacturer receives certificates of analysis in forty layouts. Each is read into the same schema on arrival, checked against the specification and linked to its lot, so material release starts with the data already in place.

See customer results
Forty suppliers, forty formats, and one table our quality team reads the same way every morning.
Director of QualityContract manufacturer
40suppliers' certificates read into one schema
Same daymaterial release from receipt, from a week
Biologics site

Transfer documentation assembled in weeks, not quarters.

A biologics site moving a process between sites started with recipes, process records and SOPs from both ends. Every parameter is read with its source, so the transfer package is assembled from the records rather than retyped from them.

See customer results
The transfer package used to be a quarter of retyping. Now it is the records themselves, side by side, with every number pointing back to its page.
Tech Transfer LeadBiologics site
3xfaster transfer package assembly
0values retyped by hand
FAQ

Questions about Document Intelligence.

What it reads, how it handles tables and handwriting, and where the data goes. The full set of answers is in the FAQ.

All questions and answers
Book a demo

Put the information in your records to work.

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.