Remote audits offer an indispensable tool for improving and verifying medical device, pharmaceutical, and other life science organization’s compliance with the specific standards.
Especially amongst the current travel restrictions due to the pandemic.
Although, there is no denying that the COVID-19 pandemic forced every organization to quickly adopt the new way of conducting audits, causing new challenges.
This article presents the advantages and disadvantages of remote auditing, as well as standard remote auditing best practices, life science organizations should follow.
In this article, we will cover:
- What Is a Remote Audit?
- Advantages of Remote Auditing
- Disadvantages of Remote Audits
- Remote Audit Best Practices
- Remote Auditing Checklist
- Remote Auditing Tools
- Frequently Asked Questions About Remote Auditing
What is a Remote Audit?
A remote audit, also known as an electronic audit (e-audit) or virtual audit is a way of conducting an audit using electronic systems to acquire audit evidence.
The goal of an audit is to evaluate the presented evidence and objectively determine the extent to which it complies with the specific audit criteria. The overall process of remote audits is like in an on-site audit, where auditors will ask relevant questions, aligned with the scope of the audit.
During a remote audit, a variety of electronic systems are used – file sharing, video conferencing, screen sharing tools, and Electronic Quality Management System (eQMS), for sharing and the review of the necessary documents.
Note that remote audits are typically carried out for processes that do not require an on-site visit, for example, post-market surveillance audits.
In some situations, for manufacturing new sites and facilities that have not been inspected or where an inspection is required, to obtain GMP certifications during the COVID-19 pandemic, a remote inspection may be carried out.
If an organization has not resolved issues from the previous audit, a remote audit may not be suitable.
Although it depends on the accreditation bodies, oversight bodies that govern standards, and their definition of remote audit eligibility, specific conditions apply for an audit that can be performed.
Advantages of Remote Auditing
There are various benefits of conducting a remote audit for both auditors and auditees. Below, are presented some of the most notable remote auditing advantages.
Ability to Conduct Audits From Anywhere
One of the most prominent advantages of remote audits is the possibility to share, review and analyze documentation, and processes, make observations and conduct interviews from anywhere in the world.
Saved Time and Money by Using Technology
The utilization of modern technology for file sharing and video conferencing also saves time and money. Documents are typically stored in the cloud for a low fee and can be accessed from anywhere. Moreover, travel costs and time an auditor spends on commuting are non-existent.
More Efficient Audits
The auditor then can spend more time on the most valuable activities. For instance, document review, process analysis, and writing comprehensive audit reports that outline the findings and opportunities for improvement. Due to no need for commuting to the site location, remote audits allow more flexible scheduling. They also allow more people to attend the online meeting and provide more expertise on a particular question.
Disadvantages of Remote Auditing
On the other hand, there are multiple issues both an audited organization and an auditor might face when conducting a remote audit.
Lack of Direct Interaction
Of course, during the remote audits, direct interaction is non-existent. Therefore, it is difficult to read body language, interpret emails, and online conversations. This typically means that the same topic could be redefined several times to ensure that the communication is clear.
Potential Issues With Technology
As we all experienced issues with technology, whether it is a poor network connection or audio quality, the same can happen during virtual audits. A slow network connection can result in the meeting being interrupted until the network problems are fully resolved.
Similarly, problems with audio, video quality, and/or access to the database where documents are stored can result in an unpleasant remote audit experience.
Difficulty to Inspect Physical Processes and Equipment
Arguably the biggest disadvantage of remote audits is the difficulty to conduct an audit of physical processes and equipment. Of course, only if the accreditation bodies, oversight bodies that govern standards, define remote audits as eligible for physical process inspections.
These tasks are particularly difficult to conduct online.
Some viable solutions could be:
- Making sure that all of the manufacturing locations are covered with video cameras that can be viewed through your streaming platform
- Using a GoPro camera to live stream with precision
Another thing to consider when it comes to remote audits is gathering all the necessary evidence needed for the scope of an audit, scanned in an electronic format. This would typically involve a lot more preparation work for an organization that has a paper-based QMS in comparison to an enterprise using a Quality Management Software (eQMS).
Remote Audit Best Practices
There are different ways to prepare for remote audits that make them as smooth and efficient as possible. Here are some of the best practices.
Whereas for an on-site audit, when having a paper-based QMS you would get the binders ready, for a remote audit ensure that all the necessary documents are ready to be shared on-screen or through a file-sharing platform or an eQMS. This means that all the required documents must be scanned and in an electronic format for them to be accessible remotely.
Think about the total preparation time and have that solid preparation in place, depending on the scope of an audit. Remember that you do not want to scan everything.
Consider establishing an audit workflow where you define who gets requests for documents, checks them in the file archive or eQMS, and finally shows the necessary documents.
In a scenario when you do not have a specific document scanned you want someone to quickly find it for you, scan it and upload it. You do not want an auditor sitting and waiting for the document they requested.
Good Connectivity and Technology
Align with the auditor on what IT platforms will be used for file sharing, video conferencing, and screen sharing or through an eQMS.
Make sure to have a network with a good enough bandwidth to support multiple connected people in an online meeting. Ensure every participant of your audit team is equipped with a proper video camera and microphone. Consider having necessary staff support before and during an audit in case there are any issues with the technology.
Eventually, also make sure to have a secured VPN (Virtual Private Network) system that can be connected to your chosen IT platforms.
Audit Team Training & Availability
Double-check if all audit participants are invited and can access the video conference and participate in remote audit when needed. Furthermore, it is important to ensure that everyone is aware of how to use the technology to avoid any kind of interruption.
Planning and Time Management
Much like on-site audits, remote audits require a detailed audit timetable and the agenda shared with all audit participants. Interviews should be scheduled well in advance although you should be ready to have an ad-hoc interview if needs arise.
Giving Auditors Access to an eQMS
If you already have Quality Management Software in place, should you give the auditor full access?
Well, most companies would not feel comfortable giving access to an eQMS, as it increases the risk of the auditor looking at everything and identifying more non-conformances. Which could then lead to corrective action and preventive action (CAPA), that otherwise could be avoided.
Most life science organizations having an audit want to have control over what the auditor sees and keep the focus narrow.
On the other hand, during the mock audits or preparation audit, the auditor’s job is to get “under the hood” and try to help the organization prepare for the real audit.
“As part of an internal audit or bringing in a consultant to do a third-party audit, giving them that full access to an eQMS might be a good approach. This allows the “auditor” to see everything and have the possibility to find all the little issues. So, when it comes to a notified body or FDA inspection, you will feel much more comfortable.”
– Katie O’Kelly, Consultant at Biologics Consulting
Note, in most situations, you would never give access to the full eQMS. The auditor would only get access to specific parts of the eQMS, which are necessary depending on the scope of the audit.
Remote Auditing Checklist
Feel free to use the checklist below to plan out the remote audit to make it as efficient and hassle-free as possible.
Determine if an Audit Is Required
- Take into consideration the criticality of your product
- Analyze your last audit report
- See if your organization is working through some unresolved issues from the past audits
- Have you been recently issued a warning letter?
Conduct a Pre-Agenda Meeting
- Discuss audit scope with an auditor
- Determine the IT platforms that will be used – file sharing, video conferencing, etc.
- Discuss whether in your case virtual audits are possible
- Include confidentiality agreement
- Make electronic copies of all the necessary documents
- Be ready to make electronic copies of other documents during the audit, if needed
- Make sure you have a secured VPN (Virtual Private Network) system that can be connected to your chosen IT platforms
- Ensure your network has enough bandwidth to support multiple connected meeting participants
Final Pre-Audit Preparation
- Discuss IT platforms with the audit team and ensure every participant is aware of how to use the technology
- Discuss the scope of an audit team in detail
- Ensure all meeting invitations are sent
- Share detailed audit timetable with all the audit participants
- Always test the technology, before the audit to ensure everything works as intended
Remote Auditing Tools
Remote audits are conducted through ICT (Information and Communication Technology) systems. Interviews between an auditor and an auditee can be carried out through different video conferencing tools like Skype, Zoom, and Microsoft Teams.
By using the screen sharing function, available in most video conferencing tools, the auditee can present the necessary documents.
Alternatively, files can be shared via email, Dropbox, Google Drive, Box, or best using a Quality Management Software (eQMS).
With an eQMS, the process of sharing and/or demonstrating the documents can be highly efficient for both the auditor and the auditee, when compared to more general file storage platforms.
It is hassle-free, much faster, and the negative time difference effect can also be alleviated. For instance, the auditor can interview the auditee for a few hours a day, when the business working hours of both companies overlap. Then, the auditor can review the relevant documents at his/her convenience.
Organizations can off course use Dropbox or any other cloud-based file storage platform in combination with an electronic signature software like DocuSign. However, such a “workaround” is not the best practice as there is a potential for human error.
Besides, for it to work properly, a good amount of validation is required, to get both systems, work in synergy. With this workflow, accessibility issues may also arise, as Dropbox, for example, does not allow the ease of Electronic Quality Management System, where permissions can be set, so that only specific users have permissions to delete documents, edit and sign documents. This means that, if appropriate processes are not set up, then people can, for instance, accidentally delete documents.
With a Quality Management Software like SimplerQMS, different subsystems are interlinked to each other, for example:
- Corrective actions and preventive actions (CAPA)
- Supplier Management
- Audit Management
- Change Management
- Design Control
- And others
This means that during an audit it will be much easier to find related documentation. For example, you can easily see the connection between a supplier, a supplier finding, a non-conformance issue, and a CAPA.
Documents can be signed with electronic signatures, compliant with 21 CFR Part 11 requirements. This also means that the specific location, date, and time of every electronic signature is documented. Audit trails are also easily accessible – the source of record that provides documented evidence of the changes that have been made to the file(s).
Another highly useful feature of the system is the possibility of setting up alerts, notifying when, for example, the medical equipment calibration, CAPA, NC’s, SOP’s, Training is coming due. This takes some of the human error out of the occasion but also contributes to the overall audit preparedness, and a more efficient Quality Management System.
Frequently Asked Questions About Remote Auditing
A virtual audit or a remote audit is an audit conducted using electronic systems to acquire audit evidence. Much like in a regular on-site audit, the goal of such a remote audit is to evaluate the demonstrate evidence and determine the extent to which it complies with the specific audit criteria.
Remote audits are conducted using different ICT (Information and Communication Technology) systems. Interviews are typically conducted through video conferencing tools, phone, or email. Whereas relevant documents are shared via screen recording function or cloud-based file storage.
Remote audits can be improved by following the best practices like:
• Make electronic copies of the necessary documents
• Make sure the network connection and technology works properly
• Train the audit team and ensure their availability when needed
• Plan everything accordingly and prepare a detailed timetable
The common types of audits in the life science industry are:
Internal audits – an independent assurance designed to provide value and improve an organization’s operations.
Regulatory audits – assesses organizations’ compliance with applicable Life Science regulations and standards.
Supplier audits – evaluates supplier quality processes, engineering change processes, manufacturing processes, and delivery processes.
Over time, accreditation bodies and oversight bodies will probably be increasing their remote audit capabilities and define them as more eligible in more specific cases.
However, if an auditor has never seen the physical facility before, it is hard to imagine if anything would replace that. Therefore, it might be that remote audits become more adopted in the future, especially for stage two kinds of audits, given the cost-effectiveness benefits of remote audits.
Therefore, it’s worth familiarizing yourself with the best practices outlined in this article to be better prepared for the next remote audit.