Process Automation Support for Your Facility
Process Automation (Programmable Logic Controllers and Distributed Control Systems), Supervisory Control and Data Acquisition (SCADA), and Enterprise Resource Planning (ERP) systems are an integral part of the manufacturing environment. These systems often control process parameters and data that relate to critical product quality attributes. With that, the systems themselves become GMP critical and subject to FDA 21 CFR Part 11 and EU Annex 11. Design, specification, and development of software often is required to follow GAMP® 5 guidelines.
At ProPharma Group, our team of process experts will assist you in all aspects of process automation including design, construction, installation, commissioning, testing, operation, and maintenance of automated systems within a pharmaceutical, biotechnology, or medical device manufacturing or development facility.
Multi-Disciplinary Approach to Process Automation
Our multi-disciplinary approach combines process engineering, computer systems validation (CSV), and data integrity. We support the design and qualification of new systems as well as improvements, changes, or upgrades to existing systems. Our team of process experts can support your organization’s automation efforts by:
- Providing the execution of Commissioning and Qualification activities
- Supporting investigations, periodic reviews, and audits
- Supporting Technical Transfer