Design, Production & Process Controls

Driving Compliance, Quality, and Performance

We have experience validating most systems and processes found in the Regulated Industry covering all stages of product development including materials, components, manufacturing processes and utilities as well following cGMPs, Industry Standards and Regulatory Requirements. This includes but is not limited to:

• Product Development (PDLM)
• Design Verification & Validation
• Components Qualification
• Process Development (Process Characterization, DOE)
  
• Process Validation (IQ, OQ, PQ)
• Test Method Validation (TMV)
• Computarized Systems Validation (CSV)
• Cleaning Validation 
• Facilities & Utilities Qualification 
• Remediation (Quality Systems & Documentation)​​

Continuous Improvement 

Call Us Today  +1.787.466.5933 | info@vanguardsolutions.us

Whether process improvement or cost improvement projects, years of project implementation give our Engineers and Consultants the expertise to provide a full range of continuous improvement opportunities. Following cGMPs, Risk Management and Regulatory Requirements, our experts have experience implementing Lean and Six Sigma tools providing you the results you need to keep your business  competitive, productive and efficient. This includes but is not limited to:

• Work Measurement
  
• Line Balancing 
• Layout Improvement
  
• Workplace design (Ergonomics) 
  
• Process Improvement Projects
• Cost Improvement Projects (CIPs)
  
• Process Analysis​​

project Management services

As project managers we specialize in planning, coordinating and executing projects from conceptualization to completion according to clients specific requirements and constrains. Our goal is to implement the assigned work of a project within a certain time, budget, and scope.