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DESIGN
Pre-construction
Phase
Quality & Validation Oversight Activities
EXECUTE
CRITICAL DESIGN REVIEWS
Implement GMP Critical Design Reviews of Facilities, Direct Impact Utilities, Equipment, Computer Systems
· Implement FDA Pre-Construction Reviews of all Required Documentation from the A & E to insure compliance to the FDA, CFR, and ISO Guidelines
· Review Facility and Critical Utility "Basis of Design" Specifications for FDA compliance
· Review Design and Bid Specifications; Equipment, Automation (PLC/DCS/DDC/ATC), Computers and Application Software
DEVELOP SPECIFICATIONS
· Develop User Requirements Specifications (URS)
· Develop or Review Design Specifications for CFR Compliance
DEVELOP VALIDATION PLANS
· Develop Validation/Project Master Plans (VMP’s)
· Develop or Review Corporate Validation Policies and Guidelines
AUDIT VENDORS AND SYSTEMS SUPPLIERS
Execute Equipment, Supplier ISO and GMP Validation Audits
CONSTRUCTION
- INSTALLATION PHASE
TO
CONTACT US
Phone:
908-369-3161
Fax: 908-369-1262
Email: rsickinger@mfgauto.com