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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: https://www.accessdata.fda.gov/scripts/ 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 https://asq.org/quality-resources/quality-management-system “A quality management system (QMS) is defined as a…
