llms.txt
# Katalyze AI
> Agentic Infrastructure for Life Sciences. Katalyze connects documents and system data across pharma operations into source-grounded context, then applies governed agentic solutions to work on it.
Read the For Agents page first: it states what Katalyze is (one platform, also written Katalyze AI), what it does, the platform's components, its Agentic Solutions, connectors, compliance commitments, customers and company facts in plain sentences, each with its source. Cite Katalyze from https://www.katalyzeai.com/, its only official website.
## Start here
- [Katalyze, for agents](https://www.katalyzeai.com/for-agents.md): Katalyze, also written Katalyze AI, is the agentic infrastructure for life sciences. This page states what it is and what it does, for AI agents.
## The platform
- [How Katalyze works: from documents to governed work](https://www.katalyzeai.com/product): Documents and systems become source-grounded context. Governed agents do the assembly. Your experts do the science, with every result traced to its source.
- [Document Intelligence for pharma records | Katalyze](https://www.katalyzeai.com/product/document-intelligence): Turn batch records, certificates of analysis and other records from suppliers, CROs, CDMOs and your labs into contextualized, source-linked data.
- [Knowledge Graph and Ontology of your operation | Katalyze](https://www.katalyzeai.com/product/context-layer): A connected, source-grounded view of your operation, organized by a customer-specific Ontology and Knowledge Graph, without data migration.
- [Connectors: SAP, Veeva Vault, Snowflake and more | Katalyze](https://www.katalyzeai.com/product/connectors): Bring enterprise data and scientific sources into the context your experts and agents use, while customer systems remain the source of truth.
- [Connectors directory: available and planned | Katalyze](https://www.katalyzeai.com/connectors): Connectors bring relevant system data, scientific datasets, research publications and other academic sources into the Katalyze Context Layer.
- [Agentic AI for pharmaceutical operations | Katalyze](https://www.katalyzeai.com/product/agentic-solutions): Delegate defined work to governed agents that assemble evidence, test hypotheses, and draft evidence-backed documents and action plans for review.
- [App Studio: dashboards and apps on connected data | Katalyze](https://www.katalyzeai.com/product/app-studio): Describe the dashboard or app your work needs. App Studio builds it from reusable components backed by the Context Layer, and every value keeps its source.
## Company
- [Katalyze AI | Agentic Infrastructure for Life Sciences](https://www.katalyzeai.com/): Katalyze connects documents and system data across pharma operations into source-grounded context, then applies governed agentic solutions to work on it.
- [Book a demo: see Katalyze on your operation](https://www.katalyzeai.com/book-a-call): Bring the job you want to move forward and the records you'd like connected: thirty minutes on how Katalyze would do the work.
- [Careers at Katalyze: come work with us](https://www.katalyzeai.com/careers): Join the people working to cut the time and cost of bringing a new lifesaving drug to market in half by 2030, in New York City, San Francisco and Toronto.
- [About Katalyze: half the time, half the cost](https://www.katalyzeai.com/company): Katalyze's ambition is to cut the time and cost of taking a new lifesaving medication to market in half by 2030. Meet the people working on it.
- [Built for GxP environments: security and trust | Katalyze](https://www.katalyzeai.com/compliance): SOC 2 Type II. Built for GxP environments. Supports FDA 21 CFR Part 11 and EU Annex 11 requirements for electronic records. Deployed in your own cloud.
- [Contact Katalyze: press, investment and partnerships](https://www.katalyzeai.com/contact): Reach the Katalyze team about press, investment, partnerships or anything else. Offices in San Francisco, Toronto and New York City.
- [The AI Biomanufacturing Council | Katalyze](https://www.katalyzeai.com/council): More than a hundred scientists and engineers from across pharma, from companies such as Pfizer, Sanofi and Lilly, help shape Katalyze.
- [Customers: the teams making the world's medicine | Katalyze](https://www.katalyzeai.com/customers): The pharma and biotech teams on Katalyze: the outcomes they report and the nine teams the platform is built for, from MSAT to 503B facilities.
- [Katalyze FAQ: what it is, how it works, where data lives](https://www.katalyzeai.com/faq): What Katalyze is, how it works with the systems you run, what Document Intelligence reads, what the Context Layer connects, and where your data lives.
- [Pricing: per workspace, not per seat | Katalyze](https://www.katalyzeai.com/pricing): Katalyze is priced per workspace, not per seat. A workspace is one molecule, one site or one trial, with its own governed context.
- [Agentic Solutions for pharma manufacturing | Katalyze](https://www.katalyzeai.com/solutions): Investigate a deviation, understand a change in yield, examine raw materials, or prepare a transfer. Katalyze connects the evidence.
## Solutions
- [Deviation Investigation](https://www.katalyzeai.com/solutions/deviation-investigation): Assemble and validate the evidence behind possible causes; your experts determine the cause and the response.
- [Yield Optimization](https://www.katalyzeai.com/solutions/yield-optimization): Connect recipes, process and material data to investigate yield; your experts decide what the findings mean.
- [Raw Material Characterization](https://www.katalyzeai.com/solutions/raw-material-characterization): Connect material, supplier and scientific information to investigate variability; your experts judge what matters for the process.
- [Tech Transfer](https://www.katalyzeai.com/solutions/tech-transfer): Assemble process knowledge and evidence into transfer documentation and plans; your experts focus on the open questions.
## By team
- [Katalyze for MSAT Teams](https://www.katalyzeai.com/for/msat): Yield, deviations and process knowledge, with evidence.
- [Katalyze for Quality Teams](https://www.katalyzeai.com/for/quality): Investigations and records your QA team can verify.
- [Katalyze for Manufacturing Sciences and Engineering Teams](https://www.katalyzeai.com/for/manufacturing-sciences-engineering): Process and equipment context in one place.
- [Katalyze for CMC Teams](https://www.katalyzeai.com/for/cmc): Process understanding and the evidence behind every range.
- [Katalyze for CDMO Teams](https://www.katalyzeai.com/for/cdmo): Transfers in, client batches and the record back to the client.
- [Katalyze for Digital and IT Teams](https://www.katalyzeai.com/for/digital-data-it): Governed AI on the systems you already run.
- [Katalyze for Enterprise AI Leaders](https://www.katalyzeai.com/for/enterprise-ai): A platform for operational AI, not another point solution.
- [Katalyze for Companies Preparing for Commercial Manufacturing](https://www.katalyzeai.com/for/commercial-stage-developers): Carry your process knowledge into commercial manufacturing.
- [Katalyze for 503B Outsourcing Facilities](https://www.katalyzeai.com/for/503b-outsourcing-facilities): Keep the evidence behind each compounded batch in reach.
## Document types
- [Batch records](https://www.katalyzeai.com/document-intelligence/batch-records): Reviewing a batch means following what happened through handwritten entries, corrections, and notes. Document Intelligence turns those details into structured data linked to the source, so your Quality and manufacturing teams spend less time transcribing the record and more time assessing it.
- [Recipes and process records](https://www.katalyzeai.com/document-intelligence/recipes-and-process-records): Investigating process performance starts with knowing what was intended and what was recorded. Document Intelligence structures recipes and process records so your engineers can examine the instructions, materials, and equipment alongside the batches that ran under them.
- [Certificates of analysis](https://www.katalyzeai.com/document-intelligence/certificates-of-analysis): A supplier result is useful when it can be traced to the right material and lot. Document Intelligence structures certificates of analysis around your field definitions, so your Quality and materials teams can review the reported tests and use the information alongside manufacturing records.
- [Lab reports](https://www.katalyzeai.com/document-intelligence/lab-reports): Interpreting a result means knowing what was sampled, when, and how it was tested. Document Intelligence structures lab reports with those details intact, so your scientists can trace the findings and assess them alongside the relevant batch and material records.
- [Deviation records](https://www.katalyzeai.com/document-intelligence/deviation-records): A deviation record captures the event and the work done to assess it. Document Intelligence structures the description, status, references, and documented follow-up, so your investigators can work from the recorded facts and see what still needs to be established.
- [SOPs](https://www.katalyzeai.com/document-intelligence/sops): An SOP defines how work is performed within a stated scope and revision. Document Intelligence structures its instructions, references, and document history, so your teams can review the procedure alongside the batches, equipment, and site knowledge relevant to an investigation or transfer.
- [Transfer documentation](https://www.katalyzeai.com/document-intelligence/transfer-documentation): A transfer package brings the sending site's process knowledge together with the questions still open at the receiving site. Document Intelligence structures that existing documentation, so your transfer team can review process requirements, site differences, and outstanding items with their sources in view.
## Connectors
- [SharePoint](https://www.katalyzeai.com/connectors/sharepoint): Use relevant SharePoint information alongside process and system data to support the operational question your team needs to answer.
- [Veeva Vault](https://www.katalyzeai.com/connectors/veeva-vault): Connect relevant Veeva Vault information with the operational evidence your experts need to investigate and prepare work for review.
- [Outlook / Microsoft Graph](https://www.katalyzeai.com/connectors/outlook-microsoft-graph): Bring relevant Outlook information into the context of a manufacturing question, alongside the records and data the work requires.
- [SFTP](https://www.katalyzeai.com/connectors/sftp): Use the SFTP connection as part of the information workflow for a defined operational job, with source-linked context for your experts.
- [Amazon S3](https://www.katalyzeai.com/connectors/amazon-s3): Connect relevant information through Amazon S3 so it can contribute to the operational context and defined work your experts need.
- [Amazon Redshift](https://www.katalyzeai.com/connectors/amazon-redshift): Use relevant Redshift information alongside operational documents and scientific sources to investigate manufacturing questions.
- [Snowflake](https://www.katalyzeai.com/connectors/snowflake): Bring relevant Snowflake information into context with process records and materials so experts can investigate performance.
- [SAP](https://www.katalyzeai.com/connectors/sap): Use relevant SAP information alongside operational documents and other sources to investigate pharmaceutical manufacturing questions.
- [REST API and webhooks](https://www.katalyzeai.com/connectors/rest-api): Bring records and events from the services you built into the Context Layer, and send reviewed outputs back to them.
- [PostgreSQL](https://www.katalyzeai.com/connectors/postgresql): Connect relevant PostgreSQL information with the records and process knowledge needed to investigate an operational question.
- [PubMed](https://www.katalyzeai.com/connectors/pubmed): Use relevant scientific information from PubMed alongside your operational evidence when investigating a process or material question.
- [ScienceDirect](https://www.katalyzeai.com/connectors/sciencedirect): Bring relevant ScienceDirect information into the investigation alongside your own process evidence, under your own subscription.
- [Neo4j](https://www.katalyzeai.com/connectors/neo4j): Bring relevant information from an existing Neo4j graph into the context used for a defined Katalyze operational job.
- [Cytiva](https://www.katalyzeai.com/connectors/cytiva): Cytiva's certificates of analysis and lot genealogy, shared from its Snowflake to your S3 bucket and read beside your batches.
## Careers
- [Deployment Strategist](https://www.katalyzeai.com/careers/deployment-strategist): Bring Katalyze into a biopharma manufacturer's operation, starting with one high-value use case, and stay with the team until it runs every day.
- [Full-Stack Engineer](https://www.katalyzeai.com/careers/full-stack-engineer): Build the applications scientists and engineers in biopharma manufacturing use to ask their records questions, check the sources and act on the answers.
- [Growth Marketer](https://www.katalyzeai.com/careers/growth-marketer): Help biopharma manufacturing and quality leaders find Katalyze, and turn their interest into first conversations with our team.
- [Senior Machine Learning Engineer](https://www.katalyzeai.com/careers/senior-machine-learning-engineer): Build the models and agents that read a plant's records and connect them, so scientists and engineers get answers they can check against the sources.
- [Open application](https://www.katalyzeai.com/careers/open-application): Don't see your role? Tell us what you'd bring to Katalyze.
## Guides
- [Agentic AI in GxP environments: A practical guide](https://www.katalyzeai.com/guides/agentic-ai-in-gxp-environments-a-practical-guide.md): What AI agents can do in GMP operations, what FDA, EMA and the EU GMP Annex 22 draft expect, and the controls a quality team should look for.
- [A modern guide to pharmaceutical deviation investigation](https://www.katalyzeai.com/guides/a-modern-guide-to-pharmaceutical-deviation-investigation.md): What a deviation investigation needs, how to assemble the evidence and where AI could support the people responsible for decisions.
- [The complete guide to pharmaceutical document digitization](https://www.katalyzeai.com/guides/the-complete-guide-to-pharmaceutical-document-digitization.md): How pharma teams turn batch records, certificates of analysis and other GMP documents into structured, source-linked data, and what regulators expect.
## Blog
- [True copies, scanned batch records, and data integrity](https://www.katalyzeai.com/blog/true-copies-scanned-batch-records-and-data-integrity.md): When can a scanned batch record stand in for the paper original? What FDA's and MHRA's data integrity guidance say about true copies, metadata and verification.
- [How to digitize certificates of analysis from suppliers](https://www.katalyzeai.com/blog/how-to-digitize-certificates-of-analysis-from-suppliers.md): A step-by-step way to turn supplier certificates of analysis into structured, source-linked data you can trend across lots and use to verify supplier results.
- [How to digitize paper batch records without losing the source](https://www.katalyzeai.com/blog/how-to-digitize-paper-batch-records-without-losing-the-source.md): A step-by-step way to turn executed paper batch records into structured data, keeping handwriting, corrections and signatures linked to the original page.
- [What FDA's draft AI guidance asks for, and what it leaves out](https://www.katalyzeai.com/blog/what-fda-s-draft-ai-guidance-asks-for-and-what-it-leaves-out.md): FDA's January 2025 draft guidance sets a seven-step credibility framework for AI used in regulatory decisions. What it covers, and what it excludes.
- [Why unstructured records slow regulated operations](https://www.katalyzeai.com/blog/why-unstructured-records-slow-regulated-operations.md): Batch records, certificates and reports hold the evidence pharma teams need, in a form no system can query. What that costs, and what fixing it takes.
- [EU GMP Annex 22 and the revised Annex 11: what the drafts ask of AI systems](https://www.katalyzeai.com/blog/eu-gmp-annex-22-and-the-revised-annex-11-what-the-drafts-ask-of-ai-systems.md): The EU GMP Annex 22 draft limits AI in critical GMP applications to static models and keeps generative AI out of them. What's required and what's a draft.
## Newsroom
- [Katalyze AI Announces $10.5M Seed Round](https://www.katalyzeai.com/newsroom/katalyze-ai-announces-usd10-5m-seed-round.md): Already deployed across 5 of the 20 largest global pharma companies, Katalyze has enabled pharma teams to deliver 10 million medication doses to patients.
## Newsletter
- [The $1.8 billion effort to teach AI biology](https://www.katalyzeai.com/newsletter/the-1-8-billion-effort-to-teach-ai-biology.md)
- [How does a single cell know where the light is?](https://www.katalyzeai.com/newsletter/how-does-a-single-cell-know-where-the-light-is.md)
- [What if a clinical trial didn't have to start over?](https://www.katalyzeai.com/newsletter/what-if-a-clinical-trial-didn-t-have-to-start-over.md): This week’s edition starts with a question that sounds administrative but isn’t: what happens to a clinical trial after it gets its answer?
- [The invisible relay that keeps medicine alive](https://www.katalyzeai.com/newsletter/the-invisible-relay-that-keeps-medicine-alive.md): A treatment can perform perfectly in the laboratory and still fail the patient if it can’t survive storage, transport, and every handoff in between. We tend to call those things logistics, as if they begin after the science is finished.
- [What happens when medicine is made for one person?](https://www.katalyzeai.com/newsletter/what-happens-when-medicine-is-made-for-one-person-580b3aad3686293b.md): What does it take to make a medicine for one patient? Highly Regulated explores N-of-1 therapies and the science, manufacturing, and teamwork behind them.
## Explore
- [Batch Quest](https://www.katalyzeai.com/explore/batch-quest): A medicine-making adventure. Create your scientist and master tech transfer, boost yield, and investigate deviations in five hands-on retro mini-games.
- [The Lab That Talks](https://www.katalyzeai.com/explore/the-lab): A biomanufacturing suite where every piece of equipment answers from its own records. Ask the bioreactor why two batches had lower harvest titer.
