Leading
the Way...
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
What
we Do
GMP Facility Design,
Construction Management
Project Management, Quality oversight
Specification
Review - Development
Systems Installation, Commissioning, Startup, Rollout
Validation
DESIGN / PRE-CONSTRUCTION
Site Location/Selection Assistance
Execute Due Diligence Surveys
Develop-Review Equipment & Systems Specifications
Facility, Room and Site Layout
Develop User Requirements Specifications (URS)
Develop or Review Facility and Equipment "Basis of Design" Specifications for FDA compliance
Develop Validation/Project Master Plans (VMP’s)
Develop Process Flow Diagrams
Develop - Review Bid Specifications
Manufacturing Automation Control Systems (PLC, DDC, DCS)
Develop User Requirements Specifications
Develop Design Specifications
Develop Master Validation Plans
Develop/Review Corporate Validation Policies and Guidelines
Provide Project Quality Oversight
Implement FDA Pre-Construction Reviews of all Required Documentation from the A & E and CM to insure compliance to the FDA and CFR
Execute Equipment, Supplier GMP - Validation Audits
Implement Critical Design Reviews and Quality Oversight
Execute
On-site Mock FDA Pre-Approval Inspections
TO
CONTACT US
Phone:
908-369-3161
Fax: 908-369-1262
Email: rsickinger@mfgauto.com