Blured text with focus on VERIFICATION Engineering Services

ICQ specializes in executing commissioning activities that are rigorously integrated with your own qualification activities, engineering procedures and quality systems.

We can also help you update current CQ&V Strategies to meet changing regulatory guidelines, or to bring your program into alignment with current industry practices.

Validation Services

At any and every stage of the validation process, we’re ready to assist with expert advice, experienced people and in-depth knowledge of regulatory guidelines and industry best practices.

At a number of manufacturing facilities, both large and small, ICQ consultants have been directly responsible for ensuring that appropriate standards were established and adhered to for all validation activities—PQ/PV, as well as CIP and SIP PQ.

Whether you need a little help with protocols and documentation, or a full-scale program that takes you from initial planning through execution and, ultimately, regulatory approval, we have the know-how and the people to get the job done effectively and efficiently.

Quality Systems

Detailed Software Development Life Cycle V-ModelIn addition to our C&Q work, we often work closely with QA staff to evaluate quality procedures, develop and execute mitigation plans and create documentation and reporting systems that are efficient, reliable and consistently reproducible.

Intelligent, risk-based quality strategies grounded in ICH-Q9/ICH-Q10 and other regulatory guidelines are being used throughout the industry to ensure product safety and regulatory compliance, while maximizing operational efficiency.

icq_pic_workerOur Compliance Specialists have an in-depth understanding of manufacturing operations, processes and systems, and are expert in the latest regulatory directions and industry best practices. As a result, we’re able to help you apply a scientific quality risk management (QRM) approach at every stage of your process—from design of unit operations, to identifying critical inspection and testing points, to developing SOPs, training and documentation.

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