From on-site audits to remote audits
The global spread of COVID-19 amongst other challenges has resulted in travel and work restrictions. This crisis has changed the way Life Sciences companies approach the GxP audits and forced them to look for new solutions that allow them to ensure business continuity and efficiently protect patients.
One of these solutions is conducting an audit remotely, which allows companies to manage the auditing process without being physically present on site.
In 2020, we at seQure, the business unit of Arithmos, turned most of the GVP audits into remote audits in order to ensure the safety of our customers and employees and guarantee business continuity.
After doing remote audits successfully for a year and a half, we would like to share some of the practical tips for conducting a successful remote GVP audit based on our experience.
Tip 1 – Scheduling the activities
If you are conducting a remote audit, you would require a longer time to review pre-audit documentation. This involves a greater quantity of documents and deliverables than what you would typically ask for in an on-site audit.
It is therefore important to:
- Provide an adequate time for auditees to collect all the documentation needed (4 weeks usually work fine)
- Plan and book in your agenda the time that you will need to review the documents (usually 1 to 2 days) prior to the interview days
- Clearly communicate to the auditees the deadlines when you are expecting to receive all the documents
Tip 2 – Collecting documents: the audit checklist
The use of an audit document checklist can help you to request all the necessary pre-audit documentation and avoid forgetting key documents.
Prepare your audit checklist using the standard format that can then be adapted based on audit type and scope.
Tip 3 – Request for English translations
In some companies, SOPs are only available in the local language. Due to the shorter audit conduction time, simultaneous translation of SOP content by the auditees as you would normally do in on-site audits might require too much time. What is more, it might be a very practical solution for your remote audits as you have limited possibilities to browse the document with the auditee.
We advise two simple workarounds:
- ask for brief summaries of SOP content in English (e.g., short PPT presentations of few slides)
- ask for SOP versions with copiable text that you can translate with a translation tool
To provide enough time for preparing this material, such a request should accompany the pre-audit document request made through the share of the audit checklist.
Tip 4 – Defining the timings for the agenda
Defining timings for interview sessions is not as simple as for on-site audits due to possible time zone differences.
The following tips can help you to define the timing for the agenda in the most efficient and effective way:
- Use a time zone converter that will allow you to compare multiple time zones at a glance
- Add to your agenda the indication of both auditee and auditor timings
Tip 5 – Pre-audit test call
Do a brief test call prior to the interview days in order to:
- check whether the system functions properly
- break the ice and present yourself to the auditees
- review the agenda with the auditees to check if any last-minute modifications are needed
Tip 6 – Setting-up your “Audit environment”
Create your own audit environment for comfortable and efficient work during your remote audit. This includes:
- organising spaces on your desk
- opening necessary files on your PC
- preparing all the tools you will need (e.g., headset, multiple monitors, paper forms, etc.).
The more comfortable you are, the less hard will be the job.
Tip 7 – Taking breaks
Conducting interviews remotely is generally more challenging for the auditors and the auditees than interviewing on-site. Make sure you plan short breaks that help to maximise efficiency and concentration.
Rule of thumb: at least a 10 – 15-minute break every 2 hours of online interview.
Tip 8 – Organising evidence
Organising the evidence while drafting the report helps you to avoid wasting time and getting lost in all the documents you have collected.
Here are a couple of tips that will help you to organise your evidence efficiently:
- Rename files so they are easily identifiable
- Transfer the documents already listed in the report into another folder, so you do not have to open them again
Are you looking for support with your audits? Our experienced team can support you with on-site and remote audits GxP, starting from defining client processes to planning, conducting, and reporting. Contact us now for a personalised proposal!