Leading the Way...

OCCUPANCY - OPERATIONAL
START-UP PHASE


OCCUPANCY/OPERATIONAL START-UP

Execute FDA type Pre Approval Inspections (PAI)

Execute Site Acceptance Test (SAT) for critical, direct impact utilities: HVAC, Chillers, Compressed Air, WFI, and all process equipment

Execute Validation Protocols (I.Q./O.Q./P.Q.'s) for critical, direct impact utilities:

· HVAC

· Chillers

· Compressed Air

· Pure Water & WFI

Execute Validation Protocols:

I.Q./O.Q./P.Q.'s for:

· Facilities

· Process/Production Equipment

· Instrumentation

· Control Systems (PLC/DDC/DCS)

· Computer and Control Systems:

· Hardware

· Application Software

· Networks

Develop and Issue Final Test and Validation Reports

Secure approvals

TO CONTACT US
Phone: 908-369-3161
Fax: 908-369-1262
Email:
rsickinger@mfgauto.com