Product: FactoryTalk PharmaSuite (also styled FactoryTalk® PharmaSuite®, and in 2012 press as Rockwell Software PharmaSuite). Current release: 12.00 (May 2025 press). Earlier named releases: 11.02.00 (September 2024) and 4.0 (June 2012). Vendor: Rockwell Automation, Inc. (NYSE: ROK), Milwaukee, Wisconsin. The 2012 release was announced under the Rockwell Software name. Rockwell has no separate PharmaSuite legal entity. Category: Pharmaceutical / life-sciences manufacturing execution system (MES) with electronic batch record execution. Not an ERP, LIMS, QMS, warehouse system, historian, or equipment-control system. The vendor page lists “quality management” and “track and trace” as application areas; PharmaSuite does not replace a QMS or a serialization product. Verification date: 2026-10-02. Scope: Public web sources only.

PharmaSuite is Rockwell Automation’s pharma eBR and MES, built on ISA-88/95 recipes, with weigh and dispense, review by exception, and cold-chain tracking. Release 12.00 moved it onto Kubernetes for cloud, on-premises, or hybrid deployment, and the visible buyers are solid-dose CDMOs, biopharma process-development groups, and plants already standardized on Rockwell automation.

1. Overview

The life-sciences product page calls PharmaSuite the leading MES purpose-built for pharmaceutical and biopharmaceutical manufacturing, integrating from enterprise systems to the shop floor. (Life sciences MES page, retrieved 2026-10-02.) The overview page adds role-based optimization, an intelligent upgrade engine, value-based applications for batch and discrete processing, and help adhering to regulatory compliance guidelines. That compliance line is a vendor claim, not a certification, GAMP category, or agency finding. (PharmaSuite overview.)

The May 2025 press release positions 12.00 for regulated pharmaceutical and biopharmaceutical environments. The one named announced adopter is Rottendorf Pharma, a solid-dose CDMO. (12.00 press, 13 May 2025.)

The product page and the March 2023 brochure name these application areas: eBR that tracks materials, equipment, and personnel; weigh and dispense; ISA S88/95 master recipes with building blocks for API, biotech, bulk, and packaging; review by exception; and integration to ERP and the automation layer. (Life sciences MES page; brochure INFO-BR003C-EN-P, March 2023.)

Related Rockwell products:

• FactoryTalk Batch, Optix, Historian, View, Linx, Analytics, Pavilion8, PlantPAx, and ControlLogix are separate products. The Dong-A ST project lists several beside PharmaSuite. (Dong-A ST case study, published 9 Jun 2023.)
• FactoryTalk ProductionCentre is a separate Rockwell MES. The 2012 4.0 press says PharmaSuite “is built on the FactoryTalk ProductionCentre platform”; the 2025 press does not repeat it. (PharmaSuite 4.0 press, 28 Jun 2012.)
• FactoryTalk Warehouse is the WMS paired with PharmaSuite at Dong-A.
• Propack Data PMX: Rockwell agreed in 2002 to buy Propack Data. No Rockwell source calls PharmaSuite a rename of PMX (section 11).
• PharmaSuite is current. Rockwell announced 12.00 on 13 May 2025 and has announced no discontinuation.

2. Company and product identity

Point	Fact	Source
Seller	Rockwell Automation, Inc., NYSE: ROK, Milwaukee. About 26,000 employees in more than 100 countries at fiscal year-end 2025.	12.00 press
Current name	FactoryTalk PharmaSuite, on a live life-sciences product page.	Life sciences MES page
Current release	FactoryTalk PharmaSuite 12.00, announced 13 May 2025; v12.00.00 on the product page.	12.00 press; product page
Prior release	11.02.00, product spotlight dated 5 September 2024.	11.02 spotlight
2012 name	“Rockwell Software PharmaSuite, version 4.0,” the next generation of MES software for regulated industries.	4.0 press, 28 Jun 2012
Stated age	12.00 “builds on more than 15 years of continuous development.” The 2012 press cites “more than 20 years of experience in pharmaceutical manufacturing,” which is company experience.	Same two press pages
Named MES managers	Martin Petrick, business manager, MES (12.00). Vladimir Preysman, then chief software strategist (4.0).	Same two press pages
Catalog numbers	9519-FTPS and 9519-FTPSSB, no dollar price shown.	9519-FTPS; 9519-FTPSSB

3. Pharma and biotech relevance

Rockwell limits the stated market to pharmaceutical and biopharmaceutical manufacturing. The 2023 brochure says recipe building blocks cover eBR for API, biotech, bulk, and packaging. Cell and gene therapy appears only in the title of the ABI Research ranking Rockwell hosts (“MES Software: Pharmaceutical, Biotech, and Cell & Gene Therapy Manufacturing Report,” March 2024). Rockwell lists no cell-and-gene function for PharmaSuite. (ABI landing page.)

Regulatory language, all from Rockwell:

• 12.00 press: cybersecurity “to support the stringent compliance and data integrity standards required in regulated life sciences environments.” Petrick says the release maintains “performance, availability, compliance and security” and will “reduce the time and cost validation.” The press makes no 21 CFR Part 11, EU Annex 11, or GAMP category statement.
• 11.02 spotlight: an improved user audit trail, a “comprehensive, tamper-proof record of system actions,” plus cold-chain tracking and “the best available state of cyber hardening.”
• Product page: “Aligned with the NIST Cybersecurity Framework,” with no published assessment.
• Brochure: upgrades “documented for compliance and verification,” with no protocol title.

4. Capabilities

Area	Fact	Source
eBR	Tracks materials, equipment, and personnel in the EBR (product page). Maintains a complete electronic batch record (2012 press).	Vendor page; press
Weigh and dispense	Pre-weighing / weigh and dispense inside the modular EBR. Rottendorf’s first step is central weighing.	Vendor page; brochure; press
Recipes	ISA S88/95 master recipes with standard building blocks for API, biotech, bulk, and packaging. 4.0 added “Intelligent Migration and Modeling Support” for recipe authoring.	Vendor page; brochure; 2012 press
Review by exception	Quality dashboard and review by exception; the EBR “lets you review by exception.”	Vendor page; brochure
Order, quality, trace	“Scalable applications”: production order management, quality management, recipe management, review by exception, track and trace.	Vendor page
Cold chain	Temperature and time requirements, time tracked in each range, operator notification, properties inherited by sublots.	Vendor page; 11.02 spotlight
Audit trail	Improved User Audit Trail (11.02).	Vendor spotlight
Upgrades	Generic Upgrade Engine across multiple versions (11.02); “a new upgrade engine” (12.00); upgrades preserve master data and batch records (2023 brochure).	Spotlight; press; brochure
12.00 architecture	Kubernetes on Linux containers; a setup tool, MICKA, that “automates installation and validation steps”; containerized components; centralized monitoring; secure development practices.	12.00 press
Extensibility	Open content and an SDK so partners and customers build functional blocks; object-oriented design and content extension (2012).	Brochure; 2012 press
Role-based UI	Separate operator and author screens; role-based optimization.	Brochure; overview page

Company-level brochure figures, not PharmaSuite counts: “95% of Fortune 500 life science companies rely on Rockwell Automation”; “more than 100 years of life sciences experience”; a Life Sciences installed base “of more than $1 billion”; “75% of the major global Life Sciences OEMs.” The brochure also claims “Fastest deployment in the industry (25 sites in five years),” with no site list, and describes the product as “Pure JAVA,” while the 12.00 press describes Kubernetes and Linux containers.

5. Architecture and deployment

Release 12.00 deploys in the cloud, on-premises, or hybrid; runs in Kubernetes on Linux containers; and adds modular containerized components, the MICKA setup tool, centralized monitoring, and a new upgrade engine. Rockwell names no cloud vendor, database, GAMP category, or validation protocol. (12.00 press.)

In 2012, Rockwell described 4.0 as built on FactoryTalk ProductionCentre, service-oriented, and object-oriented for multi-site deployment. Rockwell has not said whether 12.00 still runs on ProductionCentre. (4.0 press.)

The March 2023 brochure (INFO-BR003C-EN-P, superseding INFO-BR003B-EN-P of July 2020) says “Pure JAVA” and an upgrade engine, with no mention of Kubernetes.

Catalog structure: 9519-FTPS covers the “application platform server, phases and clients.” 9519-FTPSSB says the application “starts with a base license” and “extension licenses for functional modules as well as for design and operation users need to be added.”

6. Integrations

Source	What it says	Limit
Product page	“integrating seamlessly, from enterprise systems to the shop floor”; “Seamlessly integrate to business and operational systems as well as the automation layer.”	No named SAP, Oracle, or PLC interface
Brochure	“Seamlessly integrated to ERP systems as well as to the automation layer”; “Premier integration leverages existing Rockwell Automation investment”; “Out-of-the-box ERP integration.”	No ERP product named
2012 press	S88/S95 “allows for better integration with other enterprise systems.” Service-oriented architecture on FactoryTalk ProductionCentre.	A 2012 platform statement
Dong-A ST project	Rockwell Korea combined PharmaSuite, ProductionCentre, Enterprise Integration Hub, FactoryTalk Warehouse, ThingWorx, FactoryTalk Analytics DataView, View SE, AssetCentre, Historian, VantagePoint, Network Manager, Stratix switches, ControlLogix, and PlantPAx.	Project scope, not PharmaSuite features
Rottendorf	Central weighing is the first step toward end-to-end electronic batch recording.	Names no interface

7. Pricing and commercial model

Pricing is quote-only. Rockwell publishes no list price.

Rockwell’s commerce catalog has two PharmaSuite pages:

• 9519-FTPS: application platform server, phases, and clients. Pricing and currency depend on shipping and billing address, and an agreement type must be selected before any price appears.
• 9519-FTPSSB: a base license plus extension licenses for functional modules and for design and operation users.

The commercial model is therefore a base application license plus paid extensions by module and by user type. The brochure has a “click here to buy” prompt and no figure.

The 12.00 press cites BioPhorum’s finding that MES solutions are often perceived as expensive, slow to implement, and inflexible, then says 12.00 addresses those points. That is not a price.

Public money that is not a PharmaSuite price:

• The 2002 Propack acquisition. Control Engineering reported that terms were not disclosed. Rockwell’s filings give only combined acquisition figures (section 11). (Control Engineering, 4 Feb 2002.)
• Navy SAM.gov notice N6833526R1042, a presolicitation for Rockwell perpetual software licenses through distributor Turtle & Hughes. It does not name PharmaSuite.
• A Navy sole-source figure of $36,021.88, reported by a third-party summary of notice N68520-26-SIMACQ-JC00000-0250, for FactoryTalk, RSLinx, Studio 5000 Lite, and RSNetworx maintenance. It does not name PharmaSuite, and the figure comes from the secondary summary.

Procurement records. Searches of USAspending, EU TED, and UK Contracts Finder on 2 Oct 2026 found no award naming FactoryTalk PharmaSuite or PharmaSuite. Private-sector contracts do not appear in these registers.

Questions a buyer should ask

• Does a 12.00 sale include 9519-FTPS, 9519-FTPSSB, or both, and which functional modules cost extra?
• Is a new 12.00 system still “built on FactoryTalk ProductionCentre,” as the 2012 press said?
• What does MICKA automate in a validation package? Will Rockwell hand over a GAMP category, Part 11 / Annex 11 assessment, or supplier audit package?
• Whose cloud, what is customer-managed, and what does “reduce the time and cost validation” mean in a quote versus a protocol?
• Is there a published migration path from an installed PMX or RS PMX system?
• For Rottendorf and the unnamed biopharma story, what is in production today versus announced or estimated?

8. Implementation and validation support

The 12.00 press says MICKA automates installation and validation steps “to reduce manual effort in regulated environments.” It gives no day count, protocol name, or GAMP category.

An unnamed biopharma case study (30 April 2024) says the Process Development division finished a PharmaSuite implementation in 2023, with 10 complex recipes and system extensions, using Rockwell engineers in the United States and configuration specialists in India. The customer speaker is “the company’s Information Technology Manager.” (Case study.)

Rottendorf’s January 2024 announcement says Rockwell pharmaceutical and software specialists support the stages after central weighing. Arne Groneick, IT application manager at Rottendorf, cites the need for a pharma-specific platform and “full validation” against differing global legislation. That is the customer’s requirement, not a delivered validation package. (Rottendorf press, 16 Jan 2024.)

Dong-A ST’s project ran three years, 2020 to 2022, at the Cheonan plant, where Rockwell Automation Korea built a GMP-compliant production environment across MES, WMS, SCADA, and other products. (Dong-A ST.)

The brochure points to the Rockwell Automation PartnerNetwork for design, build, and maintain. Rockwell publishes no PharmaSuite-specific integrator list.

9. Customer evidence

Account	What is public	Weight
Rottendorf Pharma GmbH, Ennigerloh, Germany, solid-dose CDMO	16 January 2024 press: the company “is introducing” PharmaSuite, starting with central weighing as the first step to end-to-end EBR. Quotes from Pierre Teszner (Rockwell) and Arne Groneick (Rottendorf IT). The product page retells the story without a go-live date or metric.	Adoption announcement
Unnamed biopharma, Process Development division	30 April 2024. Selected PharmaSuite after a competitive review, implemented in 2023, no prior MES. Customer estimates: batch cycle from 10 to 8 weeks, two more batches a year, about 500 paper pages saved per campaign and more than 3,000 a year, a days-long report now minutes. A GMP manufacturing deployment is listed as a next use case.	Vendor case study, one non-GMP division, company withheld
Dong-A ST, Cheonan plant, Korea	9 June 2023. Project 2020–2022. PharmaSuite with ProductionCentre, Enterprise Integration Hub, FactoryTalk Warehouse, and automation products. Qualitative results: data integrity, fewer human errors, easier regulatory reporting, a GMP environment for overseas markets. The page expands COPA as “Computer Operator and Programming Assistant.”	Vendor project story, multi-product, no quantities

Other customer claims:

• The Zhejiang Medicine case-study URL (https://www.rockwellautomation.com/en-us/company/news/case-studies/zhejiang-medicine-company-improves-compliance-with-mes-software.html) is dead (404).
• The brochure quotes an unnamed “Biotechnology PharmaSuite Customer”: “Best choice on the market for the level of functionality and flexibility required.”
• The unnamed-biopharma case study says “Most large companies in the Life Sciences industry are already using PharmaSuite in some capacity,” with no list.
• “Nine of the world’s top 10 pharmaceutical manufacturers” in the 2002 Propack announcement refers to Propack Data in 2002.

10. Competitive and third-party context

ABI Research. Rockwell’s landing page says PharmaSuite “was named a Leader and Top Innovator by ABI Research Competitive Ranking” in “MES Software: Pharmaceutical, Biotech, and Cell & Gene Therapy Manufacturing Report,” and quotes one cold-chain sentence. The download sits behind a lead form; the thank-you page links CA-1477 ROCK ML.pdf. The thank-you page is titled “ABI Food Safety Report Thank You Page,” which does not match the PDF.

The PDF is an ABI excerpt (©2024, “Published March 2024”): a Rockwell profile plus the criteria pages, not the full score tables. It prints for Rockwell: “OVERALL: 77.3 | INNOVATION: 80.5 | IMPLEMENTATION: 74.0 | RANK: 4.” ABI defines Leader as an overall score of 75 or above, Mainstream as 60 to 75, Follower as 60 or below, and Innovation Leader and Implementation Leader as 75 or above on those scores. Rockwell meets Leader (77.3) and Innovation Leader (80.5), and misses Implementation Leader (74.0). “Top Innovator” appears on the landing page, not in the excerpt. A ranking is not a product capability.

The matrix also names Apprentice, Körber, Tulip, Siemens, Emerson, Honeywell, MasterControl, GE Digital, Dassault Systèmes, Parsec, MPDV, and Sepasoft. The excerpt does not print their scores. ABI’s narrative describes PharmaSuite as on-premises with eBR and cold-chain tracking, and mentions Rockwell’s Plex.

ABI’s catalog lists the report as published 18 March 2024, “Price: Starting at USD 4,500.” That is the report price, not a PharmaSuite license. (ABI landing page; thank-you page; ABI catalog.)

ARC Advisory Group. The 2012 press quotes Janice Abel, then principal consultant, describing PharmaSuite as covering both supply chain and manufacturing. A 2012 quote, not a current ranking.

BioPhorum appears only inside the 12.00 press, as the industry view that MES is expensive and slow.

No Gartner Magic Quadrant or IDC report on PharmaSuite is public.

FactoryTalk ProductionCentre (the 2012 platform) and FactoryTalk Warehouse (the Dong-A WMS) are separate Rockwell products.

11. Changes and renames

• 31 January 2002 (reported by Control Engineering, 4 February 2002): definitive agreement to acquire Propack Data GmbH, Karlsruhe, maker of PMX Enterprise Production Management, about 230 employees. Expected close in the first calendar quarter of 2002. Terms not disclosed. Don H. Davis quoted as chairman and CEO.
• March 2002 close, per the Form 10-Q for the quarter ended 31 March 2002 (filed 7 May 2002, CIK 0001024478): “In March 2002, the Company’s Control Systems segment acquired all of the stock of Propack Data GmbH (Propack).” The cash price of the businesses acquired, “which was primarily related to the acquisition of Propack, was approximately $55 million,” on a preliminary allocation. The other business named is Tesch GmbH (January 2002). Cash-flow line: “Acquisitions of businesses, net of cash acquired,” $(55) million for six months. (10-Q.)
• Fiscal 2002 Form 10-K (filed 25 November 2002): Control Systems acquired Tesch, Propack, the controller division of Samsung Electronics’ Mechatronics business, and SPEL. “The total cost of these acquisitions was approximately $71 million,” the majority related to Propack. Neither filing mentions PMX or PharmaSuite. (10-K.)
• No SEC filing from 1998 to 2026 mentions “PharmaSuite,” and no Rockwell filing mentions PMX. “Propack” appears only in the 2002 acquisition filings and later subsidiary lists.
• 28 June 2012: Rockwell Software PharmaSuite 4.0, the earliest use of the PharmaSuite name, built on FactoryTalk ProductionCentre.
• March 2023: brochure INFO-BR003C-EN-P.
• 9 June 2023: Dong-A ST case study.
• 16 January 2024: Rottendorf introduction.
• 30 April 2024: unnamed Process Development case study.
• 5 September 2024: 11.02.00 spotlight.
• 13 May 2025: 12.00 release (also on PR Newswire).

Rockwell has not said whether PharmaSuite succeeds Propack PMX or RS PMX, whether 12.00 still runs on ProductionCentre, or whether “Pure JAVA” still describes the 12.00 runtime.

Regulator records. FDA searches on 2 Oct 2026 found no warning letter, Form 483, or establishment record naming FactoryTalk PharmaSuite. EMA site search and EudraGMDP could not be queried for the product name.

12. Source library

Full source list: sources note. The March 2023 brochure and the ABI excerpt are linked, not stored.