Valspec

Manufacturing IT, automation, and process control systems must be validated to be in compliance with current GxP and FDA regulations. Continue reading to learn more from Proconex, proudly serving Eastern PA, South Jersey, Delaware and Maryland areas. 

System Life Cycle and Validation Services allow clients to ensure the quality of their systems through well-established methodologies which simultaneously achieve business compliance goals including Risk-Based Methodologies. These methodologies streamline project efforts, cost, and minimize project risk including:

• GAMP5
• GAMP for MES
• ASTM 2500-07
• Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment

Manufacturing Automation Systems Expertise

• Hands-on experience with the latest manufacturing IT and automation systems
• Detailed understanding of process control system principles
• Commitment to developing the most efficient System Life Cycle strategies to reduce project risk and cost
• Thorough knowledge of relevant FDA regulations and recent FDA enforcement trends
• Expertise in implementing computer systems and software applications
• Passion for assembling highly targeted resource and resource teams to meet our clients most pressing needs

DeltaV Expertise:
Experienced in providing over 550,000 service hours supporting the testing, CQV and startup of DeltaV systems in Greenfield facility and facility expansion projects, with over 50 installations to date.

• DeltaV Validation
• Quality Oversight
• Automation
• Owner’s Agent
• Project Planning

Integrated Manufacturing IT Evolution

• Manufacturing Execution Systems
• Electronic Batch Record (EBR) Systems
• ERP and ERP Interfaces
• Virtualized Manufacturing System Infrastructure
• Data Analytics and Data Visualization Applications
• Document Management Systems
• PLC
• DCS and PLC/SCADA Integration