Product: Aizon Execute Vendor: Aizon. The site legal line is Bigfinite Inc. (dba Aizon). Category: Intelligent electronic batch record (iBR on the current product page; eBR in the 2024 launch and the FAQ). Aizon says it is not a full or traditional MES. Verification date: 2026-10-02 Scope: Public web sources only.

Aizon Execute is a cloud eBR, launched in 2024 and co-designed with API maker Euroapi, that converts paper master batch records into electronic execution with review by exception and serves as the entry point to Aizon’s GxP AI platform (Unify, Predict, Agentic Studio). It suits API makers, CDMOs, and flexible small-scale plants that want eBR without a full MES project, and it is the only product in this MES set with a public price: $50,000 per site per year on AWS Marketplace.

1. Overview

The product page titles Execute an Intelligent Batch Record (iBR) and an electronic batch record for pharmaceutical manufacturing, promising customers can “go digital” “in only 6 weeks,” with “Full integration, conversion and GxP validation in just 6 weeks” (Aizon, product page, retrieved 2026-10-02).

Aizon’s FAQ answers “Is Execute a MES?” with “No, it’s not.” Execute covers the electronic batch record block (recipe creation, conversion, validation, lifecycle management, execution, auditing, analytics, and review by exception), not inventory management, quality management, or equipment logs (Aizon, FAQ).

Aizon’s pages written for language models say the same. llms.txt (updated 2026-07-06) says Execute “is not a full MES” and “is purpose-built for batch record conversion, execution, and release.” The 2026 for-llms page (updated 6 July 2026; the 2025 for-llms URL carries the same date and Execute wording) adds that Execute “does not perform shop-floor orchestration, scheduling, or capacity planning.” The undated Execute 3.0 release notes, however, open with “digital batch execution and process orchestration,” without defining the term (Aizon, Execute 3.0 notes).

Execute is separate from Unify, Predict, and Agentic Studio. llms.txt describes the stack “Execute → Unify → Predict → Agentic Studio,” in which each product works independently and Unify is the data foundation for Predict and Agentic Studio. The pharma page places Execute at “digitization,” Unify at “breaking data silos,” and Predict at “industrializing AI.”

Execute’s only public price is on AWS Marketplace: $50,000 per manufacturing site per 12 months, unlimited users at that site (AWS Marketplace, Aizon Execute). Section 7 covers what it excludes.

2. Company and product identity

The legal line is “Bigfinite Inc. (dba Aizon)” (Aizon, legal disclaimer). The company’s site is aizon.ai. aizon.com is an unrelated Korean total-care business (아이존) with a Seoul address and the email abc@aizon.com; its robots.txt names a sitemap and nothing about pharma.

Bigfinite trades as Aizon. The Aizon name was in use for the AI platform by 7 December 2020, in a Frost & Sullivan award release that predates Execute (Frost & Sullivan via PR Newswire).

Leadership: Pep Gubau (chief executive officer, chief technology officer, founder); David Merino (chief operating officer and chief financial officer); Toni Manzano (chief science officer, founder); Francesc Comas (chief customer success officer); Kevin Williams (chief commercial officer). Board: Eric Chin (Crosslink), Sunir Kapoor (Atlantic Bridge), Todd Holmes (New Vale) (Aizon, about). Offices are in San Francisco and Barcelona (llms.txt; 2026 for-llms); the 3.0 notes footer says “San Francisco, USA (HQ)” (Execute 3.0 notes).

On 9 February 2024 Aizon announced a $20 million Series C led by NewVale Capital, with Atlantic Bridge, Crosslink Capital, and Uncork Capital, to “fast-track” an eBR debut in Q3 2024 (Aizon, Series C post). Endpoints News reported the $20 million Series C on 7 February 2024, by Anna Brown (Endpoints News). llms.txt also claims “8 patents, 100+ engineers, 10+ years of development, $100M+ invested.”

Name on the page	Where	What the page says it is
Aizon Execute, Intelligent Batch Record (iBR); also “Electronic Batch Record”	Product page	Batch execution, review by exception, “only 6 weeks”
Aizon Execute, “AI-powered eBR” and “light eBR”	Launch post, 18 September 2024	Paper-to-digital batch records, co-designed with Euroapi
Intelligent Electronic Batch Records (eBR)	Product-sheet landing page	Gated download
Electronic Batch Records (EBR); “not a traditional MES”	FAQ	EBR block only
Intelligent Batch Record (eBR); “not a full MES”	llms.txt, for-llms	Batch-record digitization, execution, and release
Aizon Unify	Unify page	“GxP Data Fabric,” “production historian”; titled “Contextualized Intelligent Lakehouse”
Aizon Predict	Predict page	“GxP AI Industrialization”
Agentic Studio	Agentic Studio page	Natural-language applications and dashboards

The Aizon homepage describes “Intelligent GxP Manufacturing,” AI software as a service, and Aizon Consulting Services, without naming Execute. A banner on the homepage and product pages announces CPHI 2026 in Milan, 6 to 8 October, stand 12J49.

3. Pharma and biotech relevance

Execute was “designed to adapt seamlessly to small-scale productions and highly flexible plants, like chemical API CDMOs,” and developed with Euroapi, a global API manufacturer (Aizon launch post, 18 September 2024). Euroapi’s copy of the release uses the same framing (Euroapi).

llms.txt says Aizon sells to pharmaceutical manufacturers and CDMOs, “does not serve pre-commercial or clinical-stage-only companies,” focuses on North America and Europe with activity in Latin America and Asia-Pacific, and is “Not for large pharma enterprises with >$10B revenue.” The 2026 for-llms page drops the revenue line and cites a “Top 5 Pharma” harvesting-and-centrifugation result for Unify and Predict, not Execute.

Compliance wording:

• Product page: “a fully GMP and ALCOA+ environment, with workflows, rule enforcement and human validation” (product page).
• FAQ (company-wide): an Aizon QMS citing ISO 27001/17 and ISO 9001, cloud infrastructure, ALCOA+ data handling, electronic signatures, and an AI application lifecycle (FAQ).
• Trust center (platform): “supports compliance with 21 CFR Part 11 and EU GMP Annex 11” and “designed against GAMP 5 risk-based principles” (Aizon trust center). That is a vendor claim, not an FDA certification.

Execute fits a plant that wants paper master batch records moved into electronic execution and review by exception without a full MES. Inventory, quality processes, and equipment logs stay in other systems; the 3.0 materials list “with ERP systems” is narrower than inventory management (section 4).

Regulator records. FDA and EMA searches on 2 Oct 2026 found no record naming Aizon or Bigfinite. openFDA returned nothing for Aizon (510(k), enforcement, registration, Drugs@FDA) or Bigfinite (510(k)) (openFDA 510(k)); FDA and EMA web results for “Aizon” are other companies and medicines (A&Z Pharmaceutical, Azurity, Aion Therapeutic; Azopt, Azomyr, Aerinaze, Wainzua). This class of software is generally not a 510(k) product.

4. Capabilities

Function	Status	What is written	Source
MBR conversion, workflows, rule enforcement, human validation of the eMBR	Native	Also “MBR auto-conversion” and “automated digitization and phase identification”	Product page
Recipe change management, “familiar look and feel”	Native	Product page	Product page
Electronic signatures, automatic event creation	Native	Trust center: signatures “designed to support” Part 11, platform level	Product page; trust center
Review by exception, automated reports, audit trails	Native	Marketplace: review by exception can “reduce batch review time by up to 80 percent”	Product page; Marketplace
50–80% review reduction; paper MBR ingested in 24–48 hours; about 0.75 customer FTE	LLM pages only	No supporting study	llms.txt; for-llms
Execution through network disruption	Native	“Protected against network disruptions and other adverse events,” no duration or scope	Product page
Concurrent recipe editing	Native	Two users on one recipe, not the same phase at once; released recipes cannot be deleted; draft deletion is audited	FAQ
“Real-time, AI-generated insights”	Slogan	Predict is the named ML product; Aizon does not say which models run inside Execute	Product page; Predict
Cleaning and non-GxP recipes with simpler lifecycles	3.0 notes	Undated	3.0 notes
Materials list, “seamless integration with ERP systems”	3.0 notes	Sits against the FAQ line that Execute excludes inventory management; ERP not named	3.0 notes; FAQ
OCR from equipment displays, printouts, screens	3.0 notes	No accuracy figure	3.0 notes
Common parameters across recipes and process orders	3.0 notes		3.0 notes
Process values from Unify devices	Requires Unify	“Link Execute recipe components directly to Unify devices”	3.0 notes
Inventory, quality management, equipment logs	Out of scope (FAQ)	3.0’s materials list is the exception	FAQ
Scheduling, capacity planning, plant-wide orchestration	Out of scope (LLM pages)	3.0 notes say “process orchestration” without definition	for-llms; 3.0 notes
GxP validation by Aizon	Service	“We handle the heavy lifting: Full integration, conversion and GxP validation in just 6 weeks.” No protocol, IQ/OQ/PQ list, or responsibility split	Product page
Aizon Consulting Services, training, train-the-trainer, helpdesk	Service	The homepage ACS timeline is a platform journey	FAQ; homepage
“Authorized partners” / “curated network of pharma-focused technology partners”	Partner	None named	FAQ; pharma page
On-premise	Not offered	“Not on-premise. Aizon is cloud-native, deployed in single-tenant AWS environments.”	for-llms; llms.txt
Part 11 / Annex 11 certification	Vendor claim only	The platform “supports” those rules	Trust center

A May 2025 AWS blog, co-written by an AWS partner architect and Aizon’s marketing director, adds drag-and-drop workflows, recipe version control, operator and reviewer signatures, timestamps, centralized recipes across sites, a Process Orders view, and an Activity Trace of user, time, action, and signature. It says Execute “scales from pilot facilities, processing 10 batches monthly to enterprise plants managing 1,000+ batches annually,” with no customer count (AWS APN blog, 6 May 2025).

5. Architecture and deployment

Each customer gets a dedicated single-tenant environment on an AWS-native serverless architecture: Amazon DocumentDB, Amazon S3, Amazon DynamoDB, Amazon Kinesis Data Streams, Amazon Data Firehose, Amazon SQS, Amazon API Gateway, and AWS Lambda. Three layers: Manager (administration and recipes), Integration (data exchange), and Executor (shop floor) (AWS APN blog).

The trust center says customer data “lives in a dedicated, single-tenant AWS environment,” Aizon staff “cannot access your data without your express written permission,” and European customers “can deploy in Dublin or Frankfurt AWS regions.” Aizon is “working with AWS on European sovereign hosting” for the CLOUD Act, a future item. Subprocessors: AWS (hosting), Atlassian (project tracking), Google (business operations) (trust center).

The Execute Marketplace listing says SaaS delivery and “Deployed on AWS: No” (Marketplace); the Predict listing says “Yes” (Predict listing). The flag is undefined and conflicts with the AWS blog.

Execute and Unify are cloud-based (FAQ); Aizon offers no on-premise option (for-llms; llms.txt).

Company certifications: ISO 9001, ISO 27001, ISO 27017, and SOC 2, with ISO 42001 “expected” by end of 2026 (trust center). No certificate numbers are published. The February 2024 Series C post says the company follows GAMP 5 for GMP data management, before Execute existed (Series C post). The trust center lists a Part 11 and Annex 11 whitepaper, and the product sheet sits behind an email form (product-sheet page).

Aizon is an “AWS Partner Network Advanced Technology Partner” (AWS blog byline) and “AWS Advanced Technology Partner” (trust center); the partner finder page shows no tier publicly (AWS APN blog; trust center).

6. Integrations

System classes. For functions outside Execute, “Execute integrates with existing systems like ERP, QMS, LIMS, and DCS” (FAQ). No SAP, LIMS, or DCS product and no interface specification is named. The 3.0 materials list enables “seamless integration with ERP systems,” again unnamed (3.0 notes).

API. “You can access all your data through a bidirectional REST API,” but “importing data back into the Aizon platform is not always possible”; Aizon “can develop” gateway apps for controlled input (FAQ). “All data is exportable via RESTful API” (trust center). The FAQ says connecting APIs or apps can push the project past 6 to 12 weeks.

Unify. Recipe components link to Unify devices for automatic value retrieval, with an audit trail (3.0 notes). Every Execute batch “flows automatically into Unify for analytics,” making Execute “the entry point” (llms.txt); data “flows directly into Aizon Unify” (Marketplace). Unify is a separate product, outside the $50,000 line.

Identity. Execute and Unify support accounts for a customer’s own customers, with policies, IP allow-lists, central monitoring, and the customer’s identity server; no identity vendor is named (FAQ).

Not integrations. “No need for MES engineers” is a slogan (product page). Aizon says its platform layers onto MES, LIMS, ERP, historians, QMS, and SCADA without replacing them (for-llms); no Execute connector to a named MES is published.

Aizon publishes no named SAP, Oracle, or Microsoft connector, no OPC or historian connector for Execute (as opposed to Unify), no serialization interface, and no interface control document.

7. Pricing and commercial model

Pricing: $50,000 per manufacturing site per 12 months on AWS Marketplace, unlimited users at that site. Aizon publishes no price on its own site. aizon.ai, the Execute page, the FAQ, and the product-sheet landing page carry no price; the Predict page says “a modest and low-risk investment” (Predict).

The Marketplace row reads: Dimension 1, “Site based subscription allows for unlimited users for each site,” cost/12 months $50,000.00 (AWS Marketplace, Aizon Execute). The charge rises when another production site is enrolled, not when users are added. The subscription includes digitized MBR conversion, recipe lifecycle management, workflows with rule enforcement, e-signatures, audit trails, and real-time shop-floor insights. It excludes GxP validation, Aizon Consulting Services, Unify, Predict, Agentic Studio, and custom integration. Refund policy: “No refund allowed.” Zero ratings and reviews. Support: sales@aizon.ai. A generic Marketplace paragraph on the same page mentions “recurring monthly usage fees through your AWS bill,” which conflicts with the annual row.

The Predict listing shows $100 per 12 months for an “Application Subscription” / “Aizon Predict Subscription Bundle,” with no unit defined (Predict Marketplace listing). It is not an Execute price.

Not prices: the $20 million Series C (Series C post; Endpoints News) and the AWS blog’s “$250 billion” AI opportunity, “$100 billion” in manufacturing, and “$800M in inventory savings” (AWS APN blog).

Procurement records. A USAspending search on 2 Oct 2026 found no award to Aizon or Bigfinite. Its only “Aizon” keyword hit is award 1333LC19F00000458 to CAPRICE ELECTRONICS, INC. ($12,695.94), unrelated (USAspending). EU TED lists nothing for Bigfinite; its three “Aizon” hits (285306-2020, 328187-2020, 642511-2021) are Greek EU cyber-crisis infrastructure notices that do not name Aizon (TED). SAM.gov requires an account (SAM.gov); UK Contracts Finder and Find a Tender were not searched (Contracts Finder; Find a Tender).

Buyer questions

1. Is the Marketplace $50,000 the contract Aizon signs directly, and do private offers replace it?
2. What is a “site” when one location has several buildings, or a CDMO runs a customer’s product as a campaign?
3. Does the $50,000 include the “GxP validation” Aizon says it handles in six weeks, or is that a services quote?
4. Are 3.0 materials, OCR, and the Unify device link inside the site fee, or do they need Unify licenses?
5. Which billing pattern is on the order form: annual with no refund, or monthly usage?
6. Is the Dublin or Frankfurt region choice included in the site fee?
7. llms.txt excludes enterprises above $10 billion revenue, while the for-llms page cites a top-five pharma story for other products. Which rule applies to an Execute bid?

8. Implementation and validation support

Aizon’s timelines differ by page:

Claim	Who	Page
“Full integration, conversion and GxP validation in just 6 weeks”; “in only 6 weeks”	Aizon	Product page
Environment “usually” in two weeks; project “typically” 6 to 12 weeks; APIs or apps can extend it	Aizon	FAQ
Kick-off to production, including GxP validation, “less than 6 months”; customer effort “~0.75 FTE”	Aizon, LLM pages	llms.txt; for-llms
“First 45 Days” off paper; Euroapi “initial system running in six weeks”	AWS blog co-written with Aizon	AWS APN blog, 6 May 2025
About 12-week platform journey (integration, exploration, validation, impact); “first results in just 6 weeks” via Aizon Consulting Services	Aizon homepage, platform-level	Homepage

Support covers implementation, initial training, train-the-trainer, a helpdesk, and unnamed “authorized partners” (FAQ) who supply “regional knowledge” (pharma page).

Aizon publishes no validation plan template, IQ/OQ/PQ contents, signatory for the validation summary, Part 11 traceability matrix, or Execute-specific GAMP 5 category. “Tested and validated with Euroapi” is a launch claim about one collaboration (Euroapi release).

9. Customer evidence

Euroapi is the only named Execute customer with its own published page. On 18 September 2024 Euroapi said it had used Execute to convert paper recipes in five languages, that Execute “has been tested and validated with Euroapi,” and that “comprehensive deployment plans are currently ongoing across all operational sites.” David Seignolle is “Chief Operating Officer of Euroapi” on that page (Euroapi). Aizon’s post the same day says Execute “is now being deployed across all Euroapi operational sites” and also calls him chief operating officer (Aizon launch post). The May 2025 AWS blog and the 2026 product page call him chief executive officer (AWS APN blog; product page). No source confirms that every Euroapi site is live.

Other Execute customers are unnamed. Pep Gubau said in September 2024 there were “several other clients on long-term contracts in addition to Euroapi” (Euroapi release; Aizon launch post).

Grifols. llms.txt lists “Named customers: Grifols, Euroapi (co-design partner)” under Execute; the 2026 for-llms page describes Grifols as a Unify plus Predict customer. Recordati and Curia on that page are also Unify or Predict stories. Marketplace reviews for Execute: zero (Marketplace).

10. Competitive and third-party context

Aizon’s FAQ positions Execute as not a traditional MES, without inventory, quality management, or equipment logs (FAQ). The product page never says “MES” except in the slogan “No need for MES engineers; Execute is much more than paper-on-glass” (product page).

llms.txt tells models not to position Aizon as an MES, LIMS, or BI replacement, and not to compare Execute with Körber PAS-X or Siemens Opcenter “on feature breadth.”

The 3.0 notes’ “process orchestration” and materials list move Aizon’s language toward MES (3.0 notes); the FAQ position stands.

On 7 December 2020, Frost & Sullivan gave Aizon a 2020 North American Enabling Technology Leadership Award for a GxP cloud AI/ML analytics platform, before Execute existed (PR Newswire). No Gartner Magic Quadrant or Forrester report covers Execute publicly.

11. Changes and renames

• By December 2020: the Aizon name is in public use; the legal name remains Bigfinite Inc., dba Aizon (legal disclaimer; PR Newswire).
• February 2024: $20 million Series C, with an eBR promised for Q3 2024 (Series C post).
• 18 September 2024: Execute launched as a “light” or “AI-powered” eBR with Euroapi (launch post; Euroapi).
• 6 May 2025: AWS blog calls it an iBR; Euroapi’s initial system ran in six weeks (AWS APN blog).
• 2025 (undated): Execute 3.0 adds materials, OCR, cleaning and non-GxP recipes, Unify value retrieval, and “process orchestration” (3.0 notes).
• 2026: the product page says iBR; the FAQ and 2024 launch say eBR or EBR. Unify is variously “GxP Data Fabric,” “production historian,” and “Contextualized Intelligent Lakehouse” (Unify).
• 6 July 2026: llms.txt, 2025 for-llms, and 2026 for-llms updated. They add figures absent from the product page (24–48 hours, 50–80 percent, 0.75 FTE, under six months, Grifols under Execute, a revenue ceiling).

12. Source library

• Aizon Execute source list