Whether you are requiring an Investigational Site, a TMF, a Database, a Statistics or a Clinical Study Report Audit our Auditors have considerable experience in all of these.

There are three components to a Routine Audit. The first being the preparation and discussion prior to the on site activity. This preparation is essential to ensure that time spent in your offices or at site is used efficiently.

The second part is the time in your office or at site. The day starts with a meeting between the relevant personnel to discuss the day, what is expected of everyone and how the audit will be conducted. At the end of the day a meeting is held to discuss the audit and provide a brief overview of the initial findings.

The final part of a routine audit is the follow-up and the formal report. This report is issued following internal QC by PharmaAudit and an Audit Certificate is provided. The PharmaAudit Team is available after the audit to discuss specific findings and can be further utilised to assist you with resolving issues.

Regulatory Inspection Preparation | SOP Development | CRO Evaluation