Services

Commissioning, Qualification, and Validation Services (CQV)

Services

Commissioning, Qualification, and Validation Services (CQV)

CQV is our full-time job and our passion. Our dedicated team will serve as your go-to resource for all aspects of your commissioning, qualification, and validation requirements — from planning and documentation to testing and start-up.

We will interface with all engineering, validation, logistics, manufacturing, and regulatory teams to provide a comprehensive, transparent progress dashboard for real-time visibility into project schedules and budgets.

Qualification and Validation Services

CQV is our full-time job and our passion. Our dedicated team will serve as your go-to resource for all aspects of your commissioning, qualification, and validation requirements — from planning and documentation to testing and start-up.

We will interface with all engineering, validation, logistics, manufacturing, and regulatory teams to provide a comprehensive, transparent progress dashboard for real-time visibility into project schedules and budgets.

Services - Commissioning

Engineering and commissioning services ensure cGMP compliance for biopharmaceutical and medical device companies building new plants, expanding or repurposing existing facilities, and commissioning / decommissioning equipment.

Services - Qualification

Comprehensive biopharma IQ, OQ, and PQ integrated with expert commissioning services ensure all facilities, systems, utilities, and equipment meet design requirements and perform under real-world conditions.

Services - Validation

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.

Services - Quality Management

We work closely with your quality team to evaluate procedures, conduct compliance audits, develop risk mitigation and action plans, and more — all the critical activities that lead to reproducible and reliable quality production.

Services - Inspection Readiness

Robust internal quality management processes — including proactive change management, risk management, and corrective action plans — will give your facility leaders confidence in passing any regulatory inspection.

Services - Project Controls

ICQ provides project control services through all phases of greenfield and brownfield capital projects, including conceptual design, basis of design, detailed design, construction, and CQV execution.

Services - Commissioning

Engineering and commissioning services ensure cGMP compliance for biopharmaceutical and medical device companies building new plants, expanding or repurposing existing facilities, and commissioning / decommissioning equipment.

Services - Qualification

Comprehensive biopharma IQ, OQ, and PQ integrated with expert commissioning services ensure all facilities, systems, utilities, and equipment meet design requirements and perform under real-world conditions.

Services - Validation

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.

Services - Quality Management

We work closely with your quality team to evaluate procedures, conduct compliance audits, develop risk mitigation and action plans, and more — all the critical activities that lead to reproducible and reliable quality production.

Services - Inspection Readiness

Robust internal quality management processes — including proactive change management, risk management, and corrective action plans — will give your facility leaders confidence in passing any regulatory inspection.

Services - Project Controls

ICQ provides project control services through all phases of greenfield and brownfield capital projects, including conceptual design, basis of design, detailed design, construction, and CQV execution.

ICQ in Action

Building success for contract manufacturing.

“I’ve worked with many other firms and I have never seen one as flexible, creative or able to bring on additional staff as our needs evolve, like ICQ.”

Chris Holmes
VP Facilities & Engineering
Paragon (now Catalent)

ICQ in Action

Building success for contract manufacturing.

“I’ve worked with many other firms and I have never seen one as flexible, creative or able to bring on additional staff as our needs evolve, like ICQ.”

Chris Holmes
VP Facilities & Engineering
Paragon (now Catalent)

Paragon (case study heading image)

Solving Complete CQV Challenges
for Our Valued Clients

 

How Can We Help You Get It Done Right?