Independence & Quality

Our Commitment to Objectivity, Integrity, and Assurance

Independence and quality are fundamental to the way Validra Clinical Compliance Ltd operates.
Our audit services are designed to provide objective, credible assurance that supports sponsor oversight, regulatory readiness, and continuous improvement.

Auditor Independence

Validra conducts audits with a clear emphasis on auditor independence and objectivity.

We ensure that:

Auditors have no direct involvement in the activities being audited
Conflicts of interest are assessed and declared prior to each assignment
Auditors are assigned based on experience, suitability, and independence
Audit findings and conclusions are based solely on objective evidence

Where potential conflicts exist, they are documented and managed in accordance with our internal procedures.

Separation of Audit and Approval

To maintain objectivity:

Audit conduct and audit report preparation are separate from audit approval
Audit reports undergo independent quality review prior to finalisation
Any issuance of audit statements or certificates is authorised independently

This separation ensures audit outputs are defensible, transparent, and credible.

Quality Management System

Validra operates under a structured Quality Management System aligned with ISO 9001 principles, supporting consistent, controlled delivery of our services.

Our QMS covers:

Document control and version management
Auditor qualification, approval, and performance review
Audit planning, conduct, reporting, and follow-up
CAPA management and continual improvement
Confidentiality and data protection

Audit Methodology

GCP audits are conducted in accordance with:

ICH-GCP E6 (R2)
Recognised auditing principles (including ISO 19011 guidance)

Our audits are:

Risk-based – focusing on areas of greatest potential impact
Systematic – planned, conducted, and reported consistently
Proportionate – aligned to scope, risk, and study activity

Audit scope, limitations, and conclusions are clearly defined and documented.

Confidentiality & Data Protection

Validra treats all client information as strictly confidential.

We maintain:

Confidentiality agreements for auditors and associates
Secure handling of electronic and paper records
Controlled access to audit documentation
Compliance with applicable data protection requirements

Continual Improvement

Quality is not static.

Validra actively:

Reviews audit performance and feedback
Monitors effectiveness of audit processes
Implements corrective and preventive actions where required
Updates procedures to reflect evolving expectations and guidanceCompliance with applicable data protection requirements

What This Means for Clients

Clients can expect:

Independent, objective audit outcomes
Clear and proportionate findings
Transparent audit processes
Outputs suitable for sponsor oversight and regulatory scrutiny

Confidence Through Independence

Validra’s commitment to independence and quality ensures that our audits provide meaningful assurance, not just documentation.

If you would like to discuss our approach to independence, quality, or audit governance, we would be pleased to speak with you.

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