Global Validation Services

Knowledge, Experience and Expertise From Rockwell Automation

We offer:• Value-added solutions for your business • A single point of responsibility for providing the right resources when you need them• Experience in planning, implementing, and managing effective risk-based

validation projects• A track record of delivering aggressively scheduled projects• A global team of life science and engineering specialists• In-depth knowledge of the industry, best practices, and regulatory requirements

Areas of experience:• Biotechnology• Active pharmaceutical ingredients• Finished pharmaceuticals• Medical devices• Nutraceuticals

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Why choose Rockwell Automation as your validation partner?

The right team for you

Without the proper validation resources, implementations can stall, extend or become more costly. Your own validation resources serve to keep you in a validated state, but the introduction of new projects, additional manufacturing locations, or unforeseen issues may cause staffing bottlenecks. You need a flexible team approach.

Rockwell Automation is the right team for you. Our group of experienced life science professionals can serve as a single point of contact for your validation needs. Whether you are implementing a project, building a new plant, facing an FDA and cGMP audit, or improving your team’s capabilities, our proven approach and team of professionals can help you. You’ll get results, such as reduced risk, greater speed to production, innovations based on industry best practice, reduced uncertainty about regulatory compliance, standardized practices and cost savings.

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The Rockwell Automation Validation Team

Our global validation team has a vast range of experience in life

science applications and processes. This allows them to more easily

interface with your quality and engineering staff, helping projects

stay on-schedule and efficient. Many of our validation engineers

participate actively on key professional committees which helps so

that our team is fully aware of new regulatory developments and

decisions and their impact.

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Which Validation Service Do You Need?You’re upgrading your system with a turnkey project

Validation of Turnkey Projects: Rockwell Automation’s fully validated turnkey solutions – using prevalidated software solutions, experienced validation staff and tools and templates – efficiently drive computer system validation. Many of the validation activities can be performed in our facilities in such a way so as to leverage into qualification, delivering a robust validated solution, while helping reduce project cost and condensing the project schedule. In addition, Rockwell Automation’s validation group functions independently from the project group, so that validation activities performed under the scope of turnkey projects are fully objective.

You have a new plant to validate

Managed Prospective Validation Projects: Validating a new plant can be a daunting task. With many diverse elements to address, the effort can lead to a huge resource and skill shortage issue. Drawing on our extensive experience in planning, implementing, and managing all aspects of new plant validation projects, Rockwell Automation’s independent validation team can work with the solution provider that you engage to provide all validation services throughout your project.

You need a remediation plan

Managed Validation Remediation Projects: Production environments are dynamic, as producers continuously work to optimize their processes. Even with change control mechanisms in place, systems come out of their validated state. Legacy systems add to the validation complexity, as many may not have been adequately documented and validated. Rockwell Automation offers validation remediation services to address these situations. We audit your systems, assess their state of validation, and develop a remediation plan. Our engineers remain on-site until the validation remediation activities bring the project to a successful close.

You need validation professionals on-site

Outsourced Validation Services: When you choose Rockwell Automation as your outsourcing provider, you gain access to a team of highly experienced engineers to manage and implement the validation and change control activities associated with maintaining your systems in a validated state. This on-site team assumes complete responsibility for all day-to-day validation activities (i.e., computer system validation, automation validation, equipment validation, process validation, and cleaning validation). Their knowledge of industry best practice can bring a new perspective to your company and can optimize your validation practices.

You want to sharpen your validation team

Validation Training Services: Rockwell Automation can improve the skills of your team by developing tailor-made validation training solutions to help meet your needs. Our custom training includes training on the validation life cycle for project teams, tester trainings, CFR Part 11 training, and on-the-job coaching.

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“...delivering a robust validated solution, while reducing project cost and condensing the project schedule.”

How has Rockwell Automation helped others with validation?Cost savings Rockwell Automation helped a biopharmaceutical company with a turnkey automation project, where the customer deemed the standard of the acceptance testing documentation for all software library modules high enough to leverage into qualification, thus eliminating the need for repeat testing.

Shorter time to implementation During a recent turnkey process technology project for a pharmaceutical client, our validation team was able to perform many of the IQ and OQ activities in a modular high containment facility before the unit was shipped to site.

Greater speed to production Our validation team developed a streamlined and robust electronic batch record validation strategy for a medical device client, allowing them to implement an extremely aggressive EBR rollout program. Improved control over compliance status At a medical device company, we performed an assessment of all computerized systems in order to identify validation requirements and status.

Less risk, more uniformity and efficiency In a large MES rollout program, we managed the validation activities on a program level and developed a common quality system for all site-specific projects with the program. This gave the customer the ability for all MES systems to be validated efficiently and consistently in 20+ sites, reducing validation planning to 30% the typical effort for a “normal” project.

Publication LIFE-AP176B-EN-P – September 2014 Copyright © 2014 Rockwell Automation, Inc. All Rights Reserved. Printed in USA.Supersedes Publication LIFE-AP176A-EN-P – January 2008

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Rockwell Automation, Inc. (NYSE:ROK), the world’s largest company dedicated to industrial automation, makes its customers more productive and the world more sustainable. Throughout the world, our flagship Allen-Bradley® and Rockwell Software® product brands are recognized for innovation and excellence.