a UNICON Company

Core Service Group offers comprehensive commissioning and qualification (CQ) services tailored to the unique needs of the life science companies. Our expert team ensures seamless and compliant transitions from construction to operation, mitigating risks and optimizing your facility's performance.

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Our Commissioning and Qualification Services Include:

 

• Design Review and Gap Analysis: Evaluating facility and equipment designs to identify potential compliance issues and recommend improvements.

• User Requirement Specification (URS) Development: Creating detailed URS documents that align with regulatory requirements and operational needs.

• Commissioning Protocols: Developing and executing comprehensive commissioning protocols to verify system and equipment performance.

• Qualification Protocols: Developing and executing installation, operational, and performance qualification (IQ/OQ/PQ) protocols.

• Documentation and Reporting: Generating accurate and compliant documentation, including protocols, reports, and deviations.

• Training: Providing comprehensive training to your staff on equipment operation, maintenance, and compliance.

Why Choose Core Service Group?

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• Deep Industry Expertise: Our team possesses extensive knowledge of industry regulations and best practices.

• Proven Track Record: Successful completion of numerous CQ projects for pharmaceutical and biotech clients.

• Customized Solutions: Tailored approach to meet your specific project requirements and timelines.

• Compliance Focus: Adherence to regulatory standards (FDA, EMA, GMP) to ensure product quality and safety.

• Efficient Project Management: Streamlined processes and effective communication for on-time and on-budget delivery.

 

By partnering with Core Service Group, you can achieve rapid and compliant commissioning and qualification, reducing time to market and minimizing operational risks.