Case Study: Upgrading Manufacturing Software and Equipment, Ensuring Compliance, and Systems Support

Upgrading servers and equipment in a manufacturing facility is a significant undertaking, particularly in regulated industries like pharmaceuticals and medical devices. At SL Controls, we have helped a range of different companies with projects like this.

One example was a medical device company that had multiple servers and machines used in the manufacture of a medical device product. Our client wanted to upgrade hardware and software while ensuring compliance.

Objectives

The objectives of this project were to:

  • Upgrade and qualify the company’s FactoryTalk applications. FactoryTalk is software application that monitors, and controls distributed server and multi-user applications.
  • Install and qualify upgraded production hardware
  • Upgrade the server infrastructure

What We Did

Our team started by performing a gap analysis to determine the scope of engineering and validation work required to achieve the client’s objectives. We also created a validation strategy to de-risk the system upgrade elements of the project.

We then created a pilot lab environment to test the applications and hardware offline.

The next steps included:

  • Upgrading and installing the software applications as required
  • Installing and qualifying a SQL server as well as managing the migration of production and asset centre databases to the new infrastructure without any loss of critical data
  • Upgrading and installing the new production hardware
  • Integrating all the applications and hardware at the customer’s site
  • Updating the customer’s procedures to ensure compliance

Results

Our involvement in the project ensured the customer’s systems were compliant, scalable, and future proof. We also provided validation packages for each FactoryTalk application with a focus on mitigating risks, data integrity, and compliance. In addition, we upgraded the security of all systems which included introducing group-based security levels.

To find out more, and to discuss how we can help and improve your production facility, please contact us at SL Controls today.

Dermot McMorrow

Dermot is SL Controls' Compliance Director. He is responsible for the company's quality management systems and maintaining high compliance standards. Dermot is a validation specialist and has extensive experience leading validation projects for clients in Ireland and internationally, particularly in the multinational pharmaceutical and medical device sectors.

View all posts by Dermot McMorrow