The coronavirus (COVID-19) pandemic has prompted worldwide travel restrictions and remote work policies, disrupting routine in-person auditing and official inspection activities throughout the regulated life science industry.
In March of 2020, The U.S. Food and Drug Administration (FDA) announced it was scaling back foreign and domestic surveillance facility inspections and relying instead upon, among other measures, reviewing records remotely—an authority granted in section 706 of FDASIA amendments of 2012 to the FD&C Act. On July 10th, the agency announced it planned to begin resuming domestic inspections in accordance with a risk assessment during the week of July 20th.
For quality and compliance teams, the sudden workforce disruption is complicating—and often preventing—in-person quality audits led by qualified third parties. To avoid compounding delays due to canceled or deferred audits, firms are increasingly turning to remote or “virtual” audits to maintain their assurance activities until normal operations can resume.
Here, we identify the challenges of remote auditing and offer strategies and best practices for overcoming them throughout each phase of the assessment process: planning, document review, process review, facility review, interviews, and closing meetings.
Since the pandemic is a constantly-changing situation, the contents of this guide should not be considered comprehensive or definitive. We intend to add to these considerations as the environment evolves over the coming weeks or months.
This article is an excerpt from our white paper, GMP Auditing and COVID-19: A Guide to Remote Auditing and Workforce Recovery. Download it here to get all of this information and more in a handy PDF you can use as a playbook for planning and hosting remote audits.
Remote Auditing: A Brief Introduction to GMP Compliance
Remote audits enable quality and compliance teams to continue delivering ongoing assurance activities without disrupting critical operational areas when traditional in-person audits aren’t feasible.
Currently, GMP regulations do not expressly prohibit remote auditing, nor do they offer specific guidelines on proper conduct or expectations. Without official guidance, firms must determine the appropriateness and feasibility of a remote audit based on a risk assessment that considers the nature of their products and service, their technical capabilities, and factors such as compliance histories and quality trends. A remote audit may not be appropriate if the firm hasn’t resolved issues that were observed during previous audits that require an on-site visit.
"If problems were identified during a recent on-site audit—facility issues for example—and they require an on-site follow-up, it could impact the eligibility for a remote audit. Running through that checklist is important to know you’re not doing the assessment a disservice by going remote."
— Neal Siegel, Certified Auditor and Quality/Regulatory Consultant
This risk assessment should also factor in the QMS’s readiness for such an assessment, as there may be policy or procedural barriers that must be identified and addressed. For example, SOPs and specific auditing policies may be written specifically to assume in-person assessment, possibly complicating or restricting a remote auditor from certain activities, such as accessing documents.
All firms should conduct an initial risk assessment and document the outcomes achieved through remote auditing, including plans that will go into effect when current restrictions are lifted to ensure on-site audits can resume in a timely manner.
From a process perspective, remote audits largely reflect in-person audits with some obvious and not-so-obvious differences in planning and execution. When these points aren’t identified and planned for at the outset, they can present frustrating surprises along the way. This guide is intended to put these considerations on your radar. We’ve gathered expert insights from experienced auditing professionals who have seen and overcome the challenges of remote auditing firsthand.
Like a traditional in-person audit, remote audits must be planned and scoped. However, since making a contemporaneous change in a remote setting is typically more difficult than it is in person, and each audit activity may demand more time due to technical limitations, a remote audit should be fully choreographed in as much detail as possible from the start.
Both parties should budget additional time for conducting planned activities and working through unforeseen technical issues that may arise. If an audit is typically completed in two days, for example, an additional half day may be needed to conduct the same activities remotely.
Given that most organizations may not have a formal preparation plan for remote auditing projects, the following items may be of particular importance during the planning phase:
- Legal agreements barring electronic recordings: A legal document should be produced and signed by both parties to prohibit any recording of screen-shares, livestreams, or other media transmitted remotely. The risks of recording in a remote project will likely not be mitigated by existing contractual clauses.
- IT service preparation: The technical components of a remote audit can be fraught with IT issues that may not be apparent, such as firewalls, software limitations, and security risks. IT resources should be included in the planning process to identify potential problems in the project plan and make any necessary policy or technical adjustments. Both parties need to have the appropriate safety features in place.
- Connectivity and A/V checks: If a live facility walkthrough is included in the audit, the route should be checked with devices that will be used to livestream the audit prior to audit day to ensure wi-fi dead spots don’t threaten the process. This guide offers more detail on this point during its discussion of facility reviews.
Deliverables from the initial stakeholder meeting should include a full project scope and schedule with details for each activity. Knowing that even the most experienced audit participants may not be accustomed to remote auditing, an effective auditor—whether working as a certified external auditor or third-party consultant—will explain the relevant similarities and differences as well as any special actions that need to be taken.
Here are a few additional matters to consider and capture in the project plan during the initial planning phase:
- How will both parties will share information?
- Which technologies will be used to conduct or support the audit (such as cameras and teleconferencing systems)?
- What authorizations need to be obtained in advance to collect media such as photos or videos?
- What private or restricted areas need to be considered or avoided?
The audit schedule should allow for any additional time auditors need to explain the remote auditing approach to participants and take other planning steps. Also, extra coordination may be needed to accommodate for time zone differences, which can complicate the concept of an “audit day.”
As part of the initial plan, stakeholders should identify the limits of remote auditing and acknowledge that future on-site work may be required based on the remote audit findings or, in the case of a pandemic, once travel bans are lifted. Knowing that the stakeholder meetings may be conducted remotely, it’s reasonable to expect twice as much time (or more) to complete them compared to an in-person meeting.
A remote document review largely reflects the process of a traditional on-site review with the expectation of a few important differences, which we’ve summarized below.
Most facilities are organized to make documents easy to find and reference on site. It may take more time to prepare and upload documents to a platform suitable for sharing materials with an auditor versus paper record storage organizers or digital database storage. Carefully determine how and how long it will take to convert your documentation into a reviewable file format and make them available for auditors to view.
Remote auditing is rarely as efficient as on-site auditing, so consider whether sampling may be necessary. Especially in areas where a full data review is traditionally conducted, be sure to coordinate a sampling strategy with the auditor and review the strategy with audit participants so sampling can be done accurately and appropriately.
In the interest of time and convenience, remote auditors should be flexible in accepting the sharing system you prefer. If you currently use digital database storage, determine whether the software allows you to grant temporary direct access, as this can save time and effort.
While a livestreamed document review should allow for live back and forth communications, auditors may need to present questions during remote interviews instead—a requirement that should be accommodated for in the project schedule.
“As an auditor, I can’t know exactly which procedures I’ll need to review with any given firm. As a result, a firm preparing for a remote audit needs to make sure they can scan a copy of something when it’s requested or have it all ready electronically. With paper copies, it’s possible to flip through and find different sections and make notes for reference. But in a remote audit, this is much more difficult and can take far more time if accessibility becomes a problem.”
— Neal Siegel, Certified Auditor and Quality/Regulatory Consultant
Copies of key documents should be prepared ahead of time for remote review, including the quality manual, procedures, complaints log, nonconformance log, CAPA log, deviation log, validation master plan (VMP), certificates, and any other essential records. Again, accessibility is a critical aspect of the audit that should be coordinated ahead of time with the auditor.
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Facility & Process Review
Replicating an on-site facility and process walkthrough can be one of the most challenging aspects of a remote audit. If full or partial facility and process reviews are feasible, auditors should receive a facility map of the inside and outside areas to help plan needs and identify areas where photos, videos, or a streamed walkthrough will be necessary.
While livestreaming may be possible, wireless internet coverage can be spotty in some regions of a facility. Noisy environments and the limitations of A/V equipment can make real-time communication and peripheral observations difficult, if not impossible.
If a live, virtual facility tour is conducted, be sure to test your technology on the route beforehand through a dry run to ensure the risks identified above don’t pose problems.
When incorporating remote facility review into a larger remote auditing plan, auditors should note the areas they feel need to be captured through visual media like photos and video during document review. As part of this document review, auditors should note known or possible process problems, such as complaints, CAPAs, and deviations, so that they can be evaluated remotely.
As part of the planning process, both parties should discuss and agree to put the auditor in full control of the walkthrough—directing cameras and questioning to replicate the experience of an in-person tour. Expect any refusal or obfuscation to comply with an auditor’s direction to trigger an immediate project termination.
Remote interviews can be conducted much like in-person interviews through secure teleconferencing systems. Barring technical difficulties, interview times should largely match those of a traditional audit: 30 to 90 minutes with program owners, 15 to 30 minutes with implementation personnel, and shorter interviews with more general responsibilities.
Whenever possible, video calls should be used over audio-only calls so auditors can read non-verbal cues. While conducting a remote review shouldn’t take more time than a traditional audit (again, barring any technical difficulties), auditors will likely need more time to prepare.
An effective auditor will “arrive” to a virtual interview with a list of questions and discussion points to obtain additional information. If multiple auditors are involved in the same interview, all parties should make process arrangements to avoid talking over one another.
A remote closing meeting shouldn’t be substantively different from that of an in- person audit. These should typically be scheduled a day or two following interviews—a timeframe that enables auditors to review their findings and meet as a team to gather preliminary audit results.
Remote Auditing Checklist: Key Considerations
Use the checklist below as a worksheet when determining whether a remote audit is appropriate, and if so, how to plan it to be as efficient and headache-free as possible.
Conclusion and Next Steps
The COVID-19 pandemic has given rise to risks that are both unpredictable and unprecedented. Quality and compliance teams face unique challenges, but they’re also in a position to work collaboratively and use this opportunity to improve the ways they work.
By embracing alternative auditing approaches like remote auditing to continue operations in the short-term—and codify changes that make them more agile in the long-term, teams can mitigate the cancellation and deferment of audits scheduled in 2020 and emerge from this crisis more capable and prepared for uncertainty.
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GMP Auditing and COVID-19: A Guide to Remote Auditing and Workforce Recovery
Learn the challenges of remote auditing get strategies and best practices for overcoming them throughout each phase of the assessment process. This guide offers a playbook you can use to plan and host a successful remote audit.