Production & Process Automation for Life Sciences

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Integrated Automation and Reshoring Support for Pharmaceutical and Medical Device Manufacturers

Pharmaceutical and medical device manufacturers operate in highly regulated environments where product quality, patient safety, and compliance are critical. As companies respond to global supply chain disruption, cost pressures, and regulatory scrutiny, many are pursuing reshoring initiatives while investing in advanced production and process automation.

Successful reshoring and automation efforts require more than new technology. They demand careful alignment between manufacturing systems, regulatory requirements, and operational strategy. Arbour Group supports life sciences organizations by helping ensure that automated and reshored production environments are compliant, reliable, and scalable from day one.

Automation in Regulated Manufacturing Environments

Modern pharmaceutical and medical device manufacturing relies heavily on software driven production systems. Manufacturing Execution Systems (MES), automation platforms, robotics, and data analytics are essential for improving efficiency, enforcing process consistency, and maintaining traceability.

As these technologies become more integrated into core production operations, it is critical that they function as intended and support regulatory expectations. Automated systems must consistently produce accurate, reliable data and maintain control over processes that impact product quality and patient safety.

Reshoring manufacturing operations further increases the importance of your configuration and validated automation. New or relocated facilities often involve new equipment, new systems, and new workflows, all of which must be implemented in a way that supports regulatory compliance and inspection readiness.

The Strategic Value of Automation and Reshoring

• Enhanced Compliance Through Automated Processes
  Automation helps standardize manufacturing processes, reduce human error, and improve data integrity. Consistent execution and reliable electronic records strengthen compliance with regulatory requirements such as 21 CFR Part 11 and global data integrity expectations.
• Accelerating Reshoring Through Modern Manufacturing
  Reshoring production closer to key markets provides better control over supply chains, shorter lead times, and improved protection of intellectual property. When paired with automation, reshored operations can achieve higher productivity and quality while remaining cost-competitive in regulated industries.
• Improved Productivity and Risk Management
  Automated production environments enable real-time monitoring, faster deviation detection, and more proactive quality management. Addressing compliance and validation considerations early in automation or reshoring initiatives reduces the risk of delays, rework, and regulatory findings.

How Arbour Group Supports Automation and Reshoring Initiatives

Arbour Group provides compliance and validation expertise for pharmaceutical and medical device companies implementing automated production systems or reshoring manufacturing operations. Our services are designed to support both operational efficiency and regulatory readiness.

Our support includes:

• Validation of automated production and process control systems, including MES, ERP, and custom manufacturing software
  • Alignment of automation strategies with regulatory requirements and quality system expectations
  • Data integrity and electronic records compliance for software driven manufacturing environments
  • Compliance planning and execution support for reshored or newly built manufacturing facilities
  • Risk-based approaches to system implementation that focus on product quality and patient safety

Automation Platforms and Systems Expertise

Our team has experience supporting a wide range of automation and manufacturing systems commonly used in regulated life sciences environments, including platforms from Rockwell, Emerson, Honeywell, SAP, and other leading vendors, as well as quality management and data historian systems.

Why Partner With Arbour Group

Arbour Group is a trusted partner to pharmaceutical, medical device, and biotechnology companies worldwide. We combine deep regulatory knowledge with practical experience in manufacturing automation and operational transformation.

Clients rely on Arbour Group for:

• Compliance-focused automation and manufacturing support
  • Expertise in regulated production environments
  • Practical guidance during reshoring and modernization initiatives
  • Experience across FDA and global regulatory frameworks

Supporting Confident Automation and Reshoring

Whether you are implementing new automated production systems, modernizing existing operations, or reshoring pharmaceutical or medical device manufacturing, Arbour Group helps ensure your initiatives are compliant, efficient, and built for success.