How To Prepare for Remote Audits

Current restrictions on travel, brought about by Covid-19, have resulted in the increase in remote audits being carried out by health authorities.  While there might not be an auditor sitting across a meeting room table from you, there are still many issues to consider when preparing for a remote audit.  This article, from the experts in our Quality Assurance team, looks at how you can prepare for an audit that might be carried using a virtual technology tool.

This article will answer the following questions:

• What is contained in a pre-audit notification?
• What are the requirements for the auditee prior to the remote audit?
• What will happen in a virtual opening meeting?
• How will the auditor gather information during the inspection?
• How will the closing meeting be managed?

Summary of Remote Audit Process

Firstly, there is a routine process for a remote audit.

• Remote Audit Organised
• Remote Audit carried out (Opening meeting – Inspection – Closing Meeting)
• Deficiencies against requirements identified
• Report written by auditor(s)
• Responses (Corrective Actions) and timeframes submitted to the auditor(s)
• Further Responses required or Further Inspection required based on the Responses
• Close out of audit

What is contained in a pre-audit notification?

Notification will be sent to the auditee up to 6 weeks prior to an audit. The notification will contain an outline of the audit (schedule) and a list of documents required for review. This may include:

• Organogram
• Job Descriptions of Key Personnel
• Training Records
• List of SOPs
• List of Recalls
• List of Deviations / Non-Conformances / Complaints

What are the requirements for the auditee prior to the remote audit?

• Provide the auditor with all requested pre-audit documents (as listed above)
• Reliable internet access on-site
• Ensure that facilities are in order for the virtual site-tour
• Fully charged portable device with video capability (For virtual site-tour)
• A designated contact person to whom the auditor will direct all queries
• Ensure that you are comfortable with the communication platform that will be used e.g. screen-sharing, using the microphone and video options
• Prepare a Company presentation
• Review the audit schedule provided by the auditor
• If the audit is multi-departmental, ensure that the relevant personnel will be available to speak to the auditor at the assigned time-slot in the audit schedule

What will happen in a virtual opening meeting?

• The opening meeting shall be conducted by the auditor(s)
• Introductions will take place
• A Company presentation should be prepared and presented
• The schedule will be reviewed by all parties
• It is an opportunity for the auditees to ask questions prior to the beginning of the audit.

How will the auditor gather information during the inspection?

The auditor may gather the required information by:

• Asking questions during a video call on the chosen communication platform
• Requesting a video tour to see certain tasks being performed
• Requesting documentation / records

Depending on the type of audit, the designated contact person may be on video during the entirety of the audit. In other audit situations, the auditor might request to log-off from the meeting for periods of time to review documentation and will either email any queries that may arise to the designated contact person or may request a video call to discuss any issues.

How will the closing meeting be managed?

• The closing meeting shall be conducted by the auditor.
• The auditor shall explain via video call, the classification of deficiencies and present the findings of the audit during this meeting.
• Following the closing meeting, the audit is completed.

The auditor will complete the audit report and provide it to the auditee typically within three weeks. Responses (Corrective Actions) will be returned by the auditee and close-out dates for the actions will be agreed upon with the auditor. If the responses are satisfactory the audit shall be closed, and the auditor will instruct the auditee regarding follow-up audits and the next steps in the process.

We Can Help

Remote, and in-person, audits can be resource-intensive for companies.  Our quality team works consistently with companies to prepare and guide them through the audit process.  Right now, we are assisting many companies with their remote audit issues.  Contact us today if you would like us to assist your company.  Call us in Ireland on 00353 52 61 76706, email us at info@acornregulatory.com or complete the form below. [ninja_form id=1]

Further Reading

How Can Remote Audits Reduce Your Pharmacovigilance Costs?

Can remote audits really reduce costs for PV departments?  The remote or desktop audit is growing in popularity as client companies assess costs and the environmental impact of traveling to an audit site.  Furthermore, the restrictions on movement and travel brought about by the outbreak of Covid-19 has brought issues relating to travel and the safety of staff into focus.  We look at the options open to companies as they seek to contain costs, and at times such as this  – protect their staff, while maintaining standards. In accordance with GVP Module I, the MAH is responsible for performing risk-based audits of the quality system at regular intervals including audit of the PV system. The methods and conduct of these audits are outlined in GVP Module IV.