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Services and Solutions

Independent Quality Consultants (IQC) is pleased to offer a full range of consulting services including supplier qualifications and internal/external audits at very competitive rate. Our consulting services ensures that projects are initially performed correctly and that FDA requirements are fully satisfied.

  • Technical Writing: Policies, Master Validation Plans, Procedures and Work Instructions
  • Quality, Reliability, and cGMP Training
  • Supplier Qualification, Quality and GMP Internal and External Audits
  • Design Verification and Validation
  • Cleaning and Sterilization Validation
  • Utilities and Utility system Validations
  • Test Method Validation
  • Software and Computer System Validation
  • Process Validation
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Process/Product Performance Qualification (PPQ)
  • Facility and Utilities Qualification (such classified clean rooms)
  • Supplier Qualification
  • System, Design and Process Risk, Reliability & Safety Analysis
  • Lean Manufacturing and Six Sigma Programs
  • Customer Complaints Handling and CAPA
  • Regulatory Inspection Management

Process Validation

Refer to FDA 21 CFR database at: cdrh/cfdocs/cfcfr/cfrsearch.cfm Sec. 820.3 Definitions. (z) Validation means confirmation by examination…

Risk Management

Perhaps the best source to establish a risk management procedure for an FDA regulated facility is ISO 14971….

Quality Management System

According to American Society for Quality (ASQ) at “A quality management system (QMS) is defined as a…