Services

Process Validation and Computer Systems Validation

Services

Process Validation and Computer Systems Validation

Process Validation

100% right-first-time performance isn’t just a goal; it’s a reality for many of our clients. ICQ can scale to meet your validation needs — from targeted protocol reviews and documentation through full-scale validation program development and strategic planning. We will follow through to execute your validation programs and projects to help you achieve regulatory approval in record time.

We’ve helped biopharma manufacturers establish appropriate standards and execute all validation activities in facilities up to 240,000 square feet to meet business needs and continually changing regulatory requirements.

Manufacturing Process & Computer Systems Validation

Process Validation

100% right-first-time performance isn’t just a goal; it’s a reality for many of our clients. ICQ can scale to meet your validation needs — from targeted protocol reviews and documentation through full-scale validation program development and strategic planning. We will follow through to execute your validation programs and projects to help you achieve regulatory approval in record time.

We’ve helped biopharma manufacturers establish appropriate standards and execute all validation activities in facilities up to 240,000 square feet to meet business needs and continually changing regulatory requirements.

Computer System Validation and Analytical Instrument Qualification

ICQ provides a broad range of Computer System Validation (CSV) services in support of manufacturing, laboratory, and enterprise systems. We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical, risk-based approach to computer system validation.

By verifying the controlled development and implementation of computer systems, we ensure the integrity, reliability, and availability of regulated business data to support the production of quality products and protect patient safety.

Our Analytical Instrument Qualification (AIQ) services are fully integrated with comprehensive CSV best practices for ongoing IQ, OQ, and PQ or major instrument upgrades.

ICQ in Action

Getting a new facility back on track.

“In the end, the biologics manufacturing facility was commissioned and qualified with no issues noted during the FDA inspection.”

Kimberly Byrd
Former Associate Director for Validation
MannKind Corporation

Kimberly Byrd
Former Associate Director for Validation
MannKind Corporation

Validation Services

  • Cleaning Validation (CIP/COP)
  • Sterilization Validation (SIP/SOP)
  • Process Validation
  • Mixing Validation
  • Clean/Dirty Hold Validation
  • Expiry Validation
  • Cleaning Verification (CV)
  • Computer System Validation (CSV)
  • Integrated Analytical Instrument Qualification (AIQ) and CSV Services
  • Airflow Evaluation Validation
  • Validation Maintenance
  • Project Planning and Execution

Validation Services

  • Cleaning Validation (CIP/COP)
  • Sterilization Validation (SIP/SOP)
  • Process Validation
  • Mixing Validation
  • Clean/Dirty Hold Validation
  • Expiry Validation
  • Cleaning Verification (CV)
  • Computer System Validation (CSV)
  • Integrated Analytical Instrument Qualification (AIQ) and CSV Services
  • Airflow Evaluation Validation
  • Validation Maintenance
  • Project Planning and Execution

How Can We Help You Get It Done Right?