Rockwell Automation FactoryTalk PharmaSuite

Rockwell Automation's purpose-built pharmaceutical MES with electronic batch records and recipe-based production management.

FactoryTalk PharmaSuite is the pharmaceutical manufacturing execution system from Rockwell Automation, the publicly listed industrial automation company founded in 1903 and headquartered in Milwaukee, Wisconsin. PharmaSuite provides recipe-based electronic batch records, order and material management, and shop-floor integration for GMP production, with release 12.00 shipping in May 2025. Rockwell publishes documentation on applying 21 CFR Part 11 requirements with its software — conformance support rather than a certification. This profile covers the PharmaSuite product line, not Rockwell as a whole.

Headquarters
Milwaukee, United States
Founded
1903
Compliance
21 CFR Part 11
Deployment options
on-premise
Website
https://www.rockwellautomation.com/en-us/products/software/factorytalk/operationsuite/mes/pharmasuite-overview.html

Categories

AI Use Cases

  • Manufacturing Process Optimization
  • Manufacturing Quality Control

Vendor Scorecard

64% — Partial coverage. Coverage score — how completely Atlas documents Rockwell Automation FactoryTalk PharmaSuite across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.

Compliance & Validation — Documented

21 CFR Part 11

Deployment & Hosting — Documented

on premise

Pricing Transparency — Not documented by Atlas

Ask the vendor: What is your pricing model, and what drives total cost of ownership?

Implementation & Onboarding — Not documented by Atlas

Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?

Organization & Role Fit — Documented

Mid-Size Biotech, Large Pharma, Top 20 Pharma, IT / Digital, Data Management

Solution Scope — Documented

Manufacturing Process Optimization, Manufacturing Quality Control

Company Viability — Partially documented

Public, Founded 1903

Always ask the vendor

Not captured in Atlas data — confirm directly. Excluded from the score above.

Data Rights & IP

Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?

Model Credibility & Explainability

Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?

Questions to Ask This Vendor

  • How does PharmaSuite integrate with our existing Rockwell or third-party automation layer?
  • What does the upgrade path between PharmaSuite releases involve for validated environments?
  • Which recipe authoring and review-by-exception capabilities are standard?
  • What Part 11 documentation is provided to support our validation?