Leading
the Way...
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
 | |
Validation
Services
Develop Validation Master Plans
· Project Specific
· Facility Specific
· Site, Location Specific
· Corporate
Execute On-site Mock FDA Pre-Approval Inspections
Vendor, Supplier Validation, GMP/GAMP4/QSR/ICH and ISO 9000 Audits
Execute GMP/GLP Critical Design Reviews
Factory Acceptance Testing
System Test Planning
Develop Test Specifications
System Startup and Commissioning
Development and Execution of Validation Protocols for:
· Facilities
· Direct Impact Critical Utilities
· CGMP/GLP Production Equipment
· Instrumentation
Control Systems (PLC/DCS/DDC) 21CFR Part 11
Application Software Validation (21CFR Part 11)
· ERP, MRP, SAP/POMS
· Manufacturing Execution Systems (MES)
· EDC/EDS, LMS/LIMS
· SCADA
· Computerized Maintenance Management Systems
· Metrology Systems
PLC/DDC/DCS
Monitoring and Control Systems
TO
CONTACT US
Phone:
908-369-3161
Fax: 908-369-1262
Email: rsickinger@mfgauto.com