Services

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  Validra Clinical Compliance Ltd provides independent Good Clinical Practice (GCP) audits to support regulatory readiness, sponsor oversight, and continuous improvement across clinical research and product testing activities.

Our audits are conducted in accordance with ICH-GCP E6 (R2) and guided by recognised auditing principles, providing clear, objective assurance that stands up to sponsor and regulatory scrutiny.

GCP Systems Audits

Assessment of an organisation’s quality management system, governance, and GCP framework, including:

• SOP structure and document control
• Training and competency management
• Data integrity and computerised systems
• Deviation, CAPA, and continuous improvement processes

Systems audits are suitable for CROs, testing laboratories, and research organisations seeking independent assurance of their GCP framework.

  Independent audits of clinical or testing sites to assess compliance with GCP requirements, including:

• Protocol  compliance
• Informed consent processes
• Source data and data integrity
• Test product accountability
• Safety and adverse event management

These audits may be commissioned by Sponsors or conducted as part of internal quality oversight.

Focused audits aligned to a specific protocol or product, typically commissioned by Sponsors to support:

• Study oversight responsibilities
• Milestone or phase-gate decision making
• Independent  assurance during active studies

Study-specific audits are proportionate and targeted, focusing on areas of highest risk.

 Independent audits commissioned directly by Sponsors to assess CROs, vendors, or testing sites involved in product development or evaluation.

These audits support:

• Vendor qualification and oversight
• Risk-based quality management
• Objective, third-party assurance

Validra offers flexible audit delivery models, including:

• Remote / virtual audits
• On-site audits
• Hybrid approaches, combining remote review with targeted      site visits

Audit models are selected based on risk, scope, and practical considerations, with limitations clearly defined and documented.

All GCP audits are:

• Independent – auditors are free from conflicts of interest
• Risk-based – focusing on areas of highest impact
• Systematic – structured planning, execution, and reporting
• Transparent – clear findings, classifications, and conclusions

Audits are planned and conducted under a structured Quality Management System aligned with ISO 9001 principles, and guided by ISO 19011 auditing principles.

 Depending on scope, clients receive:

• A formal GCP Audit Report with findings classified by criticality
• Clear references to applicable GCP requirements
• CAPA expectations and timelines
• Follow-up review and audit closure support (if required)

Audit outputs are designed to be clear, proportionate, and defensible, supporting both internal quality improvement and external oversight needs.

• Sponsors commissioning independent GCP audits
• CROs and testing laboratories preparing for sponsor or regulatory scrutiny
• Quality teams seeking independent assurance or follow-up audits
• Organisations implementing or strengthening their GCP framework