Audit Methodology

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 Validra Clinical Compliance Ltd conducts independent, risk-based GCP audits using a structured and consistent methodology aligned with ICH-GCP E6 (R2) and guided by recognised auditing principles, including ISO 19011.

Our methodology is designed to provide objective, defensible assurance while remaining proportionate to the scope, risk, and nature of the activities audited.

All audits conducted by Validra are based on the following core principles:

• Independence and objectivity
• Risk-based focus
• Systematic planning and execution
• Evidence-based conclusions
• Clear, transparent reporting

These principles underpin every stage of the audit lifecycle.

Each audit begins with a clear definition of scope and objectives, agreed in advance with the client.

This includes:

• Audit type (systems, site, study-specific, sponsor oversight)
• Applicable standards and requirements
• Scope boundaries and exclusions
• Audit  delivery model (remote, on-site, or hybrid)

Where appropriate, a risk-based rationale is applied to focus audit effort on areas of highest potential impact.

Audits are planned in a structured and documented manner.

Planning activities include:

• Review  of background information and study documentation
• Development of a tailored audit plan and agenda
• Identification of key processes, roles, and records for review
• Confirmation of logistics, access, and confidentiality arrangements

Audit plans remain flexible and may be adjusted during the audit based on emerging risk or availability of evidence.

Audits are conducted using recognised audit techniques, including:

• Document  and record review
• Interviews with relevant personnel
• Sampling of records and source data
• Review of systems, processes, and controls

Remote audits utilise secure document sharing and video conferencing, with limitations clearly defined where physical verification is not within scope.

All audit activities focus on the collection of objective evidence.

Audit observations are evaluated against applicable requirements and classified using a structured approach.

Findings are:

• Clearly described
• Supported by objective evidence
• Referenced to applicable GCP or procedural requirements
• Classified based on potential impact and risk

This ensures findings are proportionate, consistent, and meaningful.

A formal GCP Audit Report is issued following completion of the audit.

Reports include:

• Audit scope and methodology
• Summary of activities performed
• Clearly presented findings and classifications
• Overall audit conclusion
• CAPA expectations and timelines (where applicable)
• Limitations of the audit

Reports are written to support sponsor oversight, internal quality improvement, and regulatory readiness.

Where CAPAs are required, Validra can support:

• Review  of CAPA responses for adequacy
• Assessment  of implementation and effectiveness
• Formal audit closure confirmation

Audit closure activities are conducted independently from audit delivery.

To maintain audit integrity:

• Auditors are assigned based on competence and independence
• Conflicts  of interest are assessed and documented
• Audit outputs undergo independent quality review prior to finalisation

This ensures audit outcomes are objective, credible, and defensible.

Validra’s methodology is designed to deliver meaningful assurance, not unnecessary burden.

Our audits provide:

• Clear insight into compliance status
• Practical recommendations
• Confidence for Sponsors and CROs