Service Summary
Navigate the complexities of launching a new venture seamlessly with our Start-Up and Documentation services. We specialize in guiding you through each critical phase, plus our expertise extends to the meticulous creation of documentation, aligning with industry standards and regulations. Harness the power of instructional design to streamline learning processes, facilitating a smooth transition into operational phases. With our Start-Up and Documentation services, lay the groundwork for success by combining precision, compliance, and efficiency.
- Facility/utility commissioning
- Validation/qualification documentation
- Quality system documentation
- Document control/CAD data
- Safety procedures
- Operating/maintenance manuals
- Instructional design
Start-Up and Documentation Case Studies
COVID-19 Assembly Equipment Validation
The project manager led a team to validate over 500 pieces of equipment in four weeks for a massive manufacturing push. Read on…
Medical Device Assembly – Glucose Monitor
The team had a program manager, mechanical designers, technical writers, and validation engineers with Lean and cGMP expertise. Read on…
Validation of Process for Serialization
A pharma company did not have the engineering nor program management resources needed to validate and qualify its manual process. Read on…
PROJECT LIFE CYCLE
End-to-end project delivery or a la carte services support all engineering and manufacturing stages.
Strategy
Front-end planning
Capital investment and ROI assessment
Industry and competitive benchmarking
Strategic alignment and management
Business case assessment
Production loading assessment
Site master planning
Cost-estimating
Project Management
Assemble cross-functional teams
Custom in-house or offsite solutions
Change management
Project controls
Owner’s representation
Construction management
Bid preparation
Generate project scope documents
Product Engineering
Concepting
Product development
Simulation
Design for manufacturability
Detailing
Reverse engineering
Materials selection
Prototyping
Process Engineering
Engineering methodology
Equipment and plant layout
Process automation assessment & optimization
Industrial engineering
Facilities systems
Production line design & integration
Continuous improvement
Manufacturing support & vendor selection
Equipment Engineering
Automated test systems
Robotic work cell systems
Customized equipment design
Assembly fixtures and tooling
Reverse engineering
Detailing (parts, assemblies, and BOM)
Equipment integration
Start-Up & Documentation
Validation/qualification documentation
Quality system documentation
Document control/CAD data
Safety procedures
Operating/maintenance manuals
Instructional design