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Commissioning, Qualification & Validation
Commissioning, Qualification & Validation

Our industry-leading compliance subject matter experts combine their technical and operational expertise in the areas of design, construction, commissioning, qualification, and validation to produce fully operational and compliant commercial operations.

By working on technically complex projects that span across geographic regions, industry sectors, and facility types, we have built an unmatched global regulatory understanding that allows us to provide our clients with effective and efficient regulatory decision making.

IPS Offers a Comprehensive Approach

With over 30 years of hands-on experience, IPS offers a comprehensive approach to understanding the regulations and validating within the CQV life cycle to ensure the consistency and quality of the manufactured product.

Our team of experts offers practical understanding and scientifically-based methodologies for risk- and science-based investigations, audits, remediation and quality system development services to help achieve your project goals and business objectives.

Improving Operations & Minimizing Costs

Our team focuses on increasing the efficiencies and improving cost and schedule performance of asset delivery and life cycle operations, from both a consulting perceptive and on the owner’s side. Our application of industry accepted project management approaches, lean concepts along with our collective experience allows for efficient projects as well providing a baseline for better cost of goods sold related to the life cycle areas impacted by CQV activities.

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Through our industry-leading Knowledge, Skill & Passion, we enable our clients to create and manufacture life-impacting products around the world.

Commissioning, Qualification & Validation Specialties

  • Capital Projects and Existing Facilities

    As a full service company, we simply understand and deliver projects extremely well from start to finish. We also support many clients with continuous improvement and ongoing qualification and validation activities in their new or existing facilities.

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  • CGMP Audits

    As a global service provider, our compliance experts understand the increasingly rigorous global CGMP regulations and help our clients with conforming to regulatory expectations and requirements.

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  • Commissioning

    Our team of commissioning experts possess the experience and technical knowledge to execute the most complex, demanding projects and deliver a value-driven project.

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  • Core C&Q Services

    The core of our compliance services is in the support of vendor FATs/SATs and the preparation, execution, and report generation of IQ/OQ/PQ protocols.

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  • CQV Program Development

    We apply industry best practices to help our clients develop and implement lean efficient, effective, and fully compliant CQV programs.

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  • Design Reviews and Risk Assessments

    IPS has the expertise and tools to support a robust design review and/or risk assessment process.

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  • Factory Acceptance Testing

    IPS' expertise and in-depth knowledge of global regulations and guides can maximize your factory acceptance testing experience.

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  • Quality Management Systems

    IPS has a team of experienced quality professionals to support quality system audits and policy and procedure development. 

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  • Validation and Data Integrity Services

    IPS has industry-recognized SMEs and dedicated teams that support process validation, cleaning validation, computer system validation (CSV) and data integrity, analytical methods validation, and environmental monitoring.

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    Customized Solutions for Cell & Gene Therapy


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Featured Commissioning, Qualification & Validation Experts

Featured Commissioning, Qualification & Validation Projects

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