GXP Compliance

Sopheus Sciences is a trusted global leader in providing comprehensive compliance assessments, regulatory audits, and specialized training to support GCP, GLP, and GMP activities. Our expertise helps organizations maintain regulatory excellence and operational integrity across all GxP domains.
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Clinical Trial Audits

Our experts perform study-specific GCP audits covering protocols, investigator sites, trial master files, pharmacovigilance, databases, and reporting for a wide range of clinical trials. Each audit is tailored to your compliance needs and aligned with the stage of product development.

Sopheus Sciences has conducted audits across the United States, Canada, Europe, the United Kingdom, Asia, and the Pacific Rim. We partner with sponsors and trial sites to assess, implement, and enhance quality measures that ensure compliance and maintain excellence throughout your clinical trials.

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Laboratory Audits

Sopheus Sciences is a recognized leader in supporting discovery and translational research (non-GLP), nonclinical studies (GLP), clinical research (GCP), and commercial product QC operations (GMP), ensuring data integrity and regulatory compliance.

  • Our global team of experts works with laboratories to provide a comprehensive suite of services, including:
  • Compliance audits to identify gaps and opportunities
  • Expert guidance on laboratory quality and operational issues
  • Establishment and implementation of Quality Management Systems (QMS)
  • Preparation of laboratory policies, SOPs, and QC analytical methods
  • Development and execution of routine monitoring practices
  • Training program design and delivery
  • Continuous improvement initiatives
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Clinical Trial Audits

Systems & REDCap Validation

Computerized systems play a critical role across all regulated environments (GCP, GLP, GMP), from specialized bespoke systems to commercial-off-the-shelf (COTS) solutions.

Sopheus Sciences provides tailored, comprehensive Computer Systems Validation (CSV) and auditing services across all stages of the system lifecycle. Our approach evaluates good system implementation practices, IT system management, and ensures that computerized systems are validated in accordance with regulatory requirements, including 21 CFR Part 11.

CSV assessments can be conducted as standalone audits or integrated with any of our other auditing services to provide a holistic view of compliance.

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