Full-Service Quality by Design Solutions

Process Engineering Services

- Equipment Specification and Support

- Process Operations Support

- Process Optimization

- Process Development

- Tech Transfer

- Alarm Remediation and Alarm Management

- Process Modeling

- Project Delivery

Quality Risk Management

- ASTM E2500 Planning and Implementation

- Design Review / Risk Assessment

- Change Management

- QRM Program Development and Implementation

- QRM Consulting

- QRM Training

Single-Use Systems

- Single-Use Program Development and Implementation

- Fit-for-use and Fit-for-Function Evaluation

- Leachables & Extractables Assessment

- Cost/Benefit Analysis

- Facility Fit

- Single-Use Requirements and Specifications

- Supplier/Vendor Assessment

- Component Failure Evaluation

Automation

- PLC and DCS coding

- Historian Implementation

- Test-bed Development and Implemenation

- Control System Specification and Design

- Quality System Support and Implementation

Additional Service Offerings

- Validation and Verification

- Cleaning Verification

- Protocol Generation and Execution

- Quality System Management

- Program / Project Management