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Quality
Systems Support
Execute On-site mock FDA PAI
Audits & Gap Analysis (Facilities, Utilities, Process Equipment, Computer Systems, SOP’s, Maintenance & Technical Operations)
Internal & External Quality Audits
· Quality Processes and Systems
· Policies and Standard Operating Procedures
· Corporate Quality Standards and Validation Guidelines
· GMP/GLP/QSR/ISO
Corrective Action Preventative Action (CAPA)
Failure Mode Events Analysis
Product Failures
Contamination
Environmental Monitoring
Batch Records / EBRS
Documentation Systems
Automation Systems (PLC/DDC/DCS)
Systems/Software Development
Preventative Maintenance
Calibration Program
Change Control
Training Programs
External Audits
Validation, GMP/GAMP4, QSR and ISO 9000 Audits
TO
CONTACT US
Phone:
908-369-3161
Fax: 908-369-1262
Email: rsickinger@mfgauto.com