Frequently Asked Questions

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 Yes.
Validra provides independent Good Clinical Practice (GCP) audits conducted by auditors who are free from conflicts of interest and independent of the activities being audited.

Auditor independence is assessed and documented for each assignment.

Our audits are conducted in accordance with:

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

Validra operates under a Quality Management System aligned with ISO 9001 principles.

No.
ISO 9001 certification is not a requirement to conduct GCP audits.

Validra has implemented a Quality Management System aligned with ISO 9001 principles to support consistent, controlled audit delivery.

Yes.
Validra conducts remote, on-site, and hybrid GCP audits.

Remote audits may include:

• Secure document review
• Virtual interviews
• System and process assessment

Audit delivery models are selected based on risk, scope, and practicality, with any limitations clearly documented.

Yes, when appropriately justified and documented.

Remote audits are widely accepted by Sponsors and are recognised in auditing guidance, including ISO 19011.
They are particularly suitable for:

• Systems audits
• Follow-up audits
• CAPA reviews
• Sponsor oversight activities

Yes.
Validra frequently supports Sponsor-commissioned audits of CROs, vendors, and testing sites as part of sponsor oversight and vendor qualification activities.

Yes.
Clients receive a formal GCP Audit Report, which includes:

• Audit scope and methodology
• Summary of audit activities
• Findings and classifications
• Overall audit conclusion
• CAPA expectations (where applicable)
• Documented audit limitations

Reports are written to support sponsor oversight and regulatory readiness.

Where appropriate, Validra may issue a GCP Compliance Certificate based on the scope and outcome of the audit.

Certificates:

• Reflect compliance at the time of audit
• Clearly define audit scope and limitations
• Do not imply regulatory approval

Certificate issuance is subject to independent review and authorisation.

Audit reports and any associated certificates undergo an independent quality review prior to finalisation.

The reviewer is independent of the audit delivery to maintain objectivity and integrity.

Findings are classified based on potential impact and risk, typically as:

• Critical
• Major
• Minor / Observation

Classifications are applied consistently and supported by objective evidence.

Yes.
Validra can review CAPA responses for:

• Adequacy
• Implementation
• Effectiveness

This supports timely audit closure and continuous improvement.

Audits are conducted by experienced GCP auditors with backgrounds in:

• Clinical research
• CRO operations
• Quality assurance and compliance

Auditors are selected based on competence, experience, and independence.

Yes.
Validra supports:

• Sponsors  commissioning independent oversight audits
• CROs and testing laboratories preparing for sponsor or regulatory scrutiny
• Quality teams seeking independent assurance

If you would like to discuss an audit requirement or request further information, please contact us to arrange an introductory discussion.

 Validra provides audit services on a fixed-fee or day-rate basis, depending on scope, complexity, and delivery model.
Quotations are provided following an initial discussion to ensure audit activities are proportionate and aligned to client needs.