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Virtual Audits in the Time of COVID-19: For the Auditor and the Host

The many restrictive policies in place to control the spread of COVID-19 has limited the ability of pharmaceutical company personnel to travel to and conduct audits of contract development and manufacturing organizations (CDMOs). Due to these limitations, both auditors and audit hosts must adapt and move to what is called a “virtual” or “remote” audit.

One should not confuse paper audits with virtual audits, because they are not the same. Paper audits generally include a limited review of documentation, which may include a quality survey provided by the auditor and completed by the supplier and a subset of documents such as the quality manual and copies of certifications. Alternatively, some suppliers will provide their own prepared information in lieu of completing the auditor’s survey. Paper audits are common for suppliers with many customers and help minimize the impact on their resources. A paper audit does not include a facility tour, the opportunity to interview subject matter experts (or “SMEs”), nor opening and closing meetings. Observations are not typically issued.

By contrast, a virtual (remote) audit is intended to mimic a site audit to the degree possible, based on the host’s resources. The virtual audit has the cadence of a site audit, with opening and closing meetings, a tour, document review with the hosts and SMEs available for consultation and clarification. A formal audit report with observations is issued at the completion of the audit.

The following explores virtual (remote) audits, first from the auditor’s perspective and then from the audit host’s perspective, looking specifically at the preparation, planning and conduct of the audit. Table 1 outlines differences between traditional and virtual audits.

Auditor’s Perspective

Preparation

Agenda

The first step to prepare for a virtual audit is to create a detailed and organized agenda that will maximize the effectiveness of the audit. The agenda should clearly outline the objectives of the audit tour. What areas need to be included? Are there specific pieces of equipment to be evaluated? Are there specific items to view in the virtual tour? If clean rooms are involved, badge access and interlocking door lights, visual verification of cleanable materials of construction or coved flooring and nonporous ceilings need review. The more detailed the agenda is, the better able the host is to understand and prepare for the audit.

For document review, requesting the site’s standard operating procedures (SOP) list and using this as a tool can aid in creating the agenda. As with a site audit, the agenda can be organized by area: Quality System, Facilities, Equipment, Manufacturing, Laboratory Controls, Materials, Packaging, Labeling and Distribution. Including the specific SOPs to review in the agenda and requesting them by area will enable the site to organize the documents. These documents should be uploaded to a cloud file share. Appropriate expectations should be set with the site that the documents in the agenda represent the minimum required, and that additional documents will be requested during the flow of the audit. In addition to the SOPs, any additional documents to be prepared for review, such as environmental monitoring trending reports, quality management review agendas, training records, pest control records, maintenance records and qualification/validation documents, should also be requested.

To set up the opening meeting, the first step is to agree on a date and time, just as with a site audit. The difference, however, is that regardless of all participants’ locations, the audit will occur in the time zone of the site. This can be a simple offset of just a few hours if all participants are in the United States. It can be much more problematic if the participants span both coasts of the United States, Central Europe and Asia. Tuesday at 9:00 a.m. in Beijing is Tuesday 3:00 a.m. in Central Europe, Monday 9:00 p.m. on the East Coast of the U.S. and Monday 6:00 p.m. on the West Coast. As such, the agenda will need to be clear as to the opening meeting time for all associated time zones.

Planning Meetings

Meeting one or two times with the site prior to the audit may prove helpful.

The first meeting should occur at least one week prior to the audit and ensure expectations are well understood by all parties. This meeting is critical because it will allow for agreement on document-sharing and communication platforms, as well as discussion of the details of the virtual tour. Done right, this meeting will contribute to the success of the audit.

The second meeting—a “kick the tires” meeting—should occur a couple of days prior to the audit; this presents an opportunity to verify that the sharing site can be accessed, and the documents can be opened. This time can also be used to ensure that the online conferencing platform (e.g., Microsoft® Teams, GoToMeetings®, Cisco Webex®) works for all parties. The day of the audit is not the time to discover IT issues.

During the Audit

There is no single correct way to perform an audit tour; however, the tour format should be known ahead of time to avoid surprises. One key aspect to consider is that during a virtual tour, it is more difficult to fully understand personnel, material, equipment and waste flow. If this is clearly requested ahead of time, the audit host should be able to provide a strong overview by using facility drawings and detailed photos or a video tour.

Since the pandemic, the virtual audit tour has rapidly evolved, with a variety of approaches in use.

One approach is to use detailed still photographs with an SME to narrate and describe the images. If care is taken to show detail, such as equipment stickers with identification number, calibration date, calibration due date and preventative maintenance information, this approach can be effective. To date, this is one of the more common virtual audit formats used.

Another virtual audit tour method is to provide a live tour. This can be done with a smartphone or equivalent device mounted on a gimble with a Bluetooth® microphone used for the SMEs providing the tour. This option closely mimics the traditional audit. One downside is that many facilities have “dead zones” where the sound and images may be disrupted, which may make it difficult for the auditor to watch for long periods of time.

Prerecorded tours have also been used. Some hosts may have professionally recorded tours, complete with narration, subtitles and background music. Other prerecorded tours may be as simple as the host walking around the facility with a smartphone or equivalent device and narrating as they move through the facility. Yet another is prerecording 360° views, much like those on real-estate websites, with SME narration. Finally, some audit hosts are exploring such breaking technology as “smart glasses.”

There are differences in approach for virtual audits when compared to traditional site audits, particularly when there are significant impacts due to multiple time zones. When time zones allow for it, an online conferencing platform can be opened for the working hours of the audit where the auditor(s) and host(s) can live chat, share documents and jump on a quick call. Live interactions with the host and the SMEs can provide a glimpse into the site’s culture, attitude and depth of knowledge. The live format can also facilitate real-time requests for documentation, which provides a cadence similar to a site audit and can provide insight into the site’s data integrity and data availability.

When time zones prohibit live interaction throughout the audit, email communication can serve as the primary method of communication. This is considered less effective and, if there are concerns about the host site, every effort should be made to have a live virtual audit.

Virtual opening and closing meetings tend to be quite similar to those of the traditional audit with the exception that there may be greater participation. The opening meeting includes introductions and an overview of the audit host’s organization. Typically, all participants use live video for these meetings.

Discussing a follow-up visit when travel restrictions are lifted—not necessarily an audit, but a visit to allow a tour of the facility and interface with key staff—is recommended.

Table 1 Comparison of Traditional Site Audit vs. Virtual (or “Remote)” Audit

Audit Component Traditional Site Audit Virtual (or “Remote) Audit
Audit Agenda Issued prior to audit, as per Quality Agreement; may be high-level or detailed Issued prior to the audit, as per Quality Agreement; must be detailed to ensure documents are ready (must be uploaded to a shared document location)
Audit Planning Meeting Recommended to align expectations Critical to ensure all software and IT systems function and can be accessed, virtual tour format is discussed and understood, and expectations are aligned.
Audit Opening Meeting

Representatives from host site and, minimally, the auditor or audit team

Introductions, audit scope and opening presentations are provided.

Representatives from host site and, minimally, the auditor or audit team

Generally greater participation from auditor’s and host’s leadership teams due to lack of travel requirement

Introductions, audit scope and opening presentations are provided.

Audit Tour Typically begins after the opening meeting. Auditor and audit host, as well as site SMEs, physically walk through the facility. Audit “threads,” such as requesting specific raw material lot files observed in warehouse or training files for personnel, are observed throughout the tour. Typically begins after the opening meeting. If a live tour, the audit host, as well as site SMEs, physically walk through the facility with the auditor observing remotely. Audit “threads,” such as requesting specific raw material lot files observed in warehouse or training files for personnel. are observed throughout the tour. Audit “threads” may be difficult in a still-photo tour format.
Audit Closing Meeting

Representatives from host site and, minimally, the auditor or audit team

Observations are verbally communicated.

Representatives from host site and, minimally, the auditor or audit team

Generally greater participation from auditor’s and host’s leadership teams due to lack of travel requirement

Observations are verbally communicated.

Audit Report Auditor issues report for host as per Quality Agreement requirements Auditor issues report for host as per Quality Agreement requirements
Audit Responses Host provides responses to audit observations as per Quality Agreement Requirements. Host provides responses to audit observations as per Quality Agreement Requirements.

Audit Host’s Perspective

Preparation

Site Preparation

Following confirmation of the scheduled audit, the site should begin preparations. Key personnel and SMEs will be required to support the audit, just like a traditional site audit, and early schedule coordination will ensure that personnel can devote their time to the auditor. Opening and closing meetings should be scheduled using a teleconferencing platform as soon as possible. During on-site audits, introductions to key personnel typically occur face-to-face in an office setting and business cards are shared. In the remote audit setting, developing a presentation introducing key personnel is beneficial; providing personnel names, titles and email addresses, will not only facilitate organized introductions with a set order, but will also provide personnel contact information for the auditors.

A planning meeting with the auditors is recommended to discuss the audit logistics. When requesting the planning meeting, providing relevant documents to assist the auditor with audit agenda preparation, such as a table of contents for the site SOPs, the Site Master File and the site organizational chart, is very helpful. Requesting the auditor share the agenda prior to the planning meeting will allow the host site to review the agenda content as well as provide an opportunity to discuss any points of clarification that might be necessary.

If the site has established a standard software platform for use during virtual audits, the environment should be prepared prior to the planning meeting. These preparations may include establishing a controlled environment with limited access, verifying IT access for the auditor’s domain and providing guidance to the auditors for installation and use of the platform. When evaluating a platform to use for hosting, it is important to assess the security controls within the platform as well as the platform capabilities (e.g., file storage and access, instant messaging and teleconferencing). Using one platform to support all portions of the audit simplifies the logistics of the audit for both the host and the auditor.

Audit Agenda

Upon receipt of the audit agenda, the host should review and prepare any clarifying questions.

In the document-sharing site, either the host or the auditor should establish a logical folder system to better organize the documents requested. An additional folder for deploying documents requested during the audit also provides an extra level of organization during document review. When populating the folders with the requested documents, it may be beneficial to rename the files. Often, sites will have a naming convention for documents that may be logical to site personnel but may be difficult for auditors to determine the contents of a given document without opening it. Using a “mirrored” document folder (e.g., an exact replica of the document-sharing platform) within the site network server can be beneficial for preparing the documents prior to the audit, as well as providing a repository for unloading and reloading the documents for each audit day. This mirrored folder can also serve as a record of the documents provided during the audit.

Planning Meeting

During the planning meeting, an overview of the platform to be used during the audit should be conducted. If access can be provided to the auditor prior to the planning meeting, verification of access can be performed during the meeting. At minimum, confirmation of access should be performed prior to the audit to ensure that any technical issues are resolved prior to the date of the audit.

On-site audits typically include a tour of relevant facility areas. In the virtual environment, if the capability exists, a virtual tour can be provided in lieu of the on-site tour. The auditor should be asked if there are any specific areas or items of interest (e.g., specific equipment) that are essential for viewing during the tour.

The virtual audit provides an opportunity that traditional audits do not. Typically, during the opening and closing meetings of on-site audits, only the auditor participates. When hosting the opening and closing meetings via teleconference, other members of the auditor’s team can join the meetings without incurring any additional travel costs. This added benefit can be offered during the planning meeting with no additional strain on the host.

During the Audit

During the opening meeting, following personnel introductions, the virtual tour can be performed using the teleconference. This prevents the need for auditors, hosts and tour guides to switch to a secondary teleconference. Key personnel for each area of the tour can stay on the teleconference and walk through their respective areas, providing answers to any of the auditor’s questions. While opening and closing meetings for the audit are hosted via teleconference, the document review portion of the audit does not necessarily require a continuous call. If the platform being utilized for the audit has the capability for instant messaging, this feature allows the auditor to ask a question and continue document review, while the host provides a response. Some platforms allow for replies to specific messages so that both the answer and question are grouped together. This is useful for both the auditor and host to keep track of which questions have been answered throughout the audit.

Some questions will require in-depth discussion and explanation from SMEs. For these types of questions, additional teleconferences can be set up to facilitate such discussions.

If the host and the auditor are unable to take part in the audit at the same time due to time zone differences, the instant messaging feature may still be a useful communication tool. While there will be delays in providing answers to the auditor, the auditor will have an easier time in evaluating the responses upon return to the audit.

Thoughts on the Future

Will remote audits have a place after the pandemic? The answer is “it depends.” For high-risk audits, being on site for an audit is always preferred. However, for a low-risk, routine audit, a virtual audit may be a worthwhile option. For firms with minimal personnel or budget, eliminating the costs of travel and the subsequent loss of employee time may make performing a remote audit a desirable alternative.

Governing procedures and legal documents need to be evaluated. Quality agreements are legal contracts that, among other things, outline the communication and responsibilities of each party, including each party’s responsibilities for audits. The language necessary to support virtual audits must be included in these contracts. Additionally, SOPs that govern supplier management should be updated to include the requirements and controls for virtual audits, and to allow for flexibility in conducting audits either on-site or using a virtual format.

The current situation has established that virtual audits can be a sustainable method of performing quality audits for both the auditor and host. Virtual audits are most likely here to stay.

About the Authors

Bob GreatheadBob Greathead is the Senior Specialist, Quality & Compliance at Catalent Pharma Solutions, LLC located in Madison, Wisconsin. He has over 10 years of experience in the industry in a variety of quality assurance specialties.

Michelle Stengel BernardsMichelle Stengel Bernards is the Manager, Quality & Compliance at Catalent Pharma Solutions, LLC located in Madison, Wisconsin. She has over 15 years of experience in the industry with a focus on quality assurance and regulatory affairs.

Anna GilbertAnna Gilbert is a Director in the BioProcess Technology Group at BDO USA, LLC. She has over 20 years of experience in the industry with a quality background in protein manufacturing and cell and gene therapy manufacturing.

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