Pharmaceutical Automation & Information Technology Services

Source: CAI
Intelligent Automation AI

As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.

Our Automation & IT Services:

  • 21CFR Part 11 and Annex 11 Compliance: We have experience with performing system assessments and remediating systems that are not compliant.
  • IT Infrastructure and Global Information Systems: CAI has worked with our clients to implement full system lifecycle maintenance programs, which include security controls, backup and recovery, disaster recovery, and data integrity policies and processes. We incorporate all applicable regulations and standards.
  • Process Control: CAI has worked with our customers to manage, historicize, and access process control data in the context of MES, LIMS, ERP, and other IT systems.

As we solved problems and troubleshot several types of systems, we developed philosophies that typical system integrators will not tell you. We adhere rigorously to a modular S88 approach for software organization. When given a new process that is similar to an existing process, the typical integrator defaults to the creation of a new module instead modifying the existing module to encompass the changes.

Why is CAI different?

It is easier for the integrator because they can replicate the existing module; however, this does not account for the maintenance, validation, or lifecycle costs of having an additional module, which in the long run are costlier to the customer.

When CAI drives an automation project, we philosophically push for maximum code re-use, which has the tendency to force modules to be more fault-tolerant and able to support multiple, physical configurations. In other words, we truly understand how to optimize a design in order to minimize life-cycle costs, not just integration costs.

We are a company of seasoned project managers. We know how to manage changes and configuration while focusing on value-adding activities. We promote testing code as early as possible under factory conditions because we know how to successfully manage and leverage these activities.