Our Audit Methodology

Before undertaking the detailed audit work, we conduct a structured risk assessment to identify the areas of highest regulatory significance and quality risk within the audit scope. This focuses our assessment effort on the activities and systems most likely to affect product quality, patient safety and regulatory compliance, ensuring that audit time is invested where it matters most. Risk assessment also informs the depth and intensity of review in individual audit areas.

Prior to onsite assessment, we conduct a detailed review of quality documentation relevant to the audit scope. This includes SOPs, batch records, validation reports, training records, deviation and CAPA logs, quality agreements and previous audit reports. Document review identifies areas for focused investigation during the onsite assessment and enables us to arrive on site with a detailed understanding of the documented quality system, allowing us to focus onsite time on verification rather than orientation.

A significant component of effective auditing is personnel interview. We conduct structured interviews with key personnel across quality assurance, operations, quality control and management functions to understand how quality systems function in practice, not just as documented. Process walkthroughs confirm that operational practices match documented procedures and identify discrepancies that represent compliance gaps. Interview techniques are designed to support honest, open responses rather than defensive recitation of procedure.

The onsite assessment is the core of the audit engagement. Working to the agreed audit plan, we assess quality systems, review records, conduct physical facility inspections and test quality system function against regulatory requirements. Our assessors are trained to work systematically through the audit scope while remaining alert to indicators of systemic quality issues that warrant deeper investigation. Evidence is gathered, referenced and documented throughout the assessment. Remote audit formats use structured video walkthrough, shared document platforms and live interview sessions to achieve equivalent evidence quality.

At the conclusion of onsite assessment, we conduct a formal closing meeting with your management and quality team. We present a summary of preliminary findings, explain the basis for each finding and discuss any factual matters that require clarification before the written report is issued. The closing meeting ensures that the audit team and auditee have a shared understanding of what has been observed, preventing surprises in the written report and enabling organisations to begin remediation planning promptly.

Written audit reports are issued within 10 working days of audit completion. Reports contain an executive summary, audit scope and methodology, individual findings with regulatory basis, risk classification (critical, major, minor or observation), and recommended corrective actions for each finding. Findings are described with sufficient precision that remediation actions can be designed and implemented without requiring additional clarification. Reports are written to the standard that regulatory authorities apply when reviewing an organisation's supplier audit programme.

Where requested, we review CAPA responses submitted in response to audit findings and provide a formal assessment of CAPA adequacy. We assess whether proposed actions address the identified root causes, whether implementation timelines are realistic and whether planned effectiveness checks will provide meaningful evidence of improvement. Following CAPA implementation, we can conduct effectiveness verification assessments to confirm that corrective actions have been implemented as described and have achieved the intended improvement.