Quality

A robust quality program is crucial to ensuring regulatory compliance.  Per FDA, “Quality cannot be adequately assured merely by in-process and finished-product inspection or testing.”

At QVEX Consulting, we provide the following quality services:

• Development of Quality Systems for:
• Environmental Monitoring
• Validation (protocol/report templates)
• Sterility Testing
• Bioburden Testing

• Audit

• Environmental Monitoring
• Cleanroom Certification
• Sterilization

• Non-Conformance Investigations
• Internal and Supplier Audits
• Gap Analysis
• Development of SOPs/Training Modules
  •  Environmental Monitoring
  •  Cleanroom Certification
  •  Validation