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Remote Auditing for GMP Compliance: Best Practices

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Remote Audit Technology Success Factors

Many recent articles have addressed best practices for remote audits to ensure GMP compliance. While these lists serve as a solid framework for auditors, remote audit technology success factors must be considered, prior to initiating the audit.

Ensure that your remote audit technology has the following capabilities:

  • Real-time site tours
  • Full 360-degree visibility
  • Secure document reviews
  • Built-in support

In response to global supply chain vulnerabilities exposed by the coronavirus (COVID-19) pandemic, many compliance industry professionals are calling for contingency planning that utilizes remote auditing approaches for continued monitoring of good manufacturing practice (GMP) compliance.

It is important to consider the perspective of the audit site and how remote auditing technology can alleviate any real or perceived concerns. If equipped with the know-how to effectively utilize remote auditing technology, remote audits could very well become a new industry standard.

Background

It has been generally accepted that remote audits are a viable alternative, when travel restrictions limit, or otherwise prohibit, on-site audits. However, many audit sites are uncomfortable with the idea, especially due to security concerns.

This article examines the perceived challenges, including security risks and limited abilities to visualize the facility, equipment and processes, to offer conclusions about how to best utilize remote auditing technology and continue to exceed GMP requirements. Remote auditing capabilities are not only possible but could potentially offer more benefits to both the auditor and the auditee.

Considering Remote Audit Site Concerns

To effectively conduct a remote audit, it is necessary to first understand the concerns of the audit site, in addition to the needs of the auditor. The main concern of audit sites when performing a remote audit, is the security of their proprietary information or intellectual property (IP). A well-designed remote auditing platform addresses this in three critical ways:

  • Technology: Must be secure and offer confidence that there is no possibility of unapproved or accidental sharing of proprietary information.
  • Contractual: As with any audit, standard non-disclosure and contractual agreements must be in place between the parties. These may need to be appended to include digital communication, but otherwise remain the same as a conventional audit.
  • Industry Experience: Knowledge of compliance auditing practices assures the users that their audits will be conducted in alignment with industry expectations to assure confidentiality and uphold professional standards. Experienced professionals are incentivized to maintain credibility.

Remote Audit Capabilities

If we consider the intention behind the audit itself, audits are designed to identify gaps in the quality systems or inconsistencies that indicate there may be other underlying problems. To make sure that the objective is met, a proper remote auditing platform needs to integrate the three main processes typical for an effective audit:

1. Facility Tours

In-person audits offer “boots on the ground” opportunities with ‘chaperoned’ access to facilities, utilities, staff and equipment. With advances in remote audit technology, this same effect is achievable virtually.

  • 360° Viewing: With the innovation of 360° cameras, the auditors now have a fully immersive experience during a virtual tour, allowing them an unrestricted view and the ability to control where they look, without relying on the person holding the camera.
  • Real-time capabilities: it is critical to have the lowest latency (broadcast delay) possible, so that real-time viewing is seamless. Shorter delays allow the Auditor to request a closer view of something that is in the room or to simply ask a question. This can be achieved, by balancing the resolution needs with the need for a short latency. 360°streaming is data-intensive, because it’s sending the entire 360° view, not just the 80°- 90° angle that the auditor is looking at through the interface at any given moment.

2. Document Reviews

Reviewing electronic and physical documents, such as quality manuals, procedures, change requests, complaints, nonconformances, CAPAs, equipment or calibration logs and other important records is a crucial part of the auditing process. With remote audits, this can reveal some perceived challenges from audit sites regarding how to share documents and still maintain the security of their information. Remote auditing platforms must alleviate these concerns with built-in functionality.

  • Reviewing documents: any remote audit will require the capability of viewing both electronic and physical documents, such as logbooks, binders, and paper records. Reviewing electronic documents, in particular, must be done in a way that prevents accidental or unauthorized viewing, copying, or further sharing of these documents. We like to think of it as a “for-your-eyes-only” approach. Paper documents can be reviewed using real-time Live-Streaming document cameras with adequate resolution.
  • Security: there are a number of factors to consider beyond the obvious secure connection during the audit and basic encryption. A “leave-no-trace” approach is critical to the sites being audited. Any documents reviewed during the audit are typically intended only for viewing during the audit. There are some novel technologies and techniques, such as Digital Rights Management (DRM) that should be built into the process to ensure the auditor is able to view them. However, access is restricted or revoked immediately after the audit is complete – leaving no artifacts – as it would be with an in-person audit.

3. Interviews with Staff

Another important piece of most audits is conducting staff interviews. Having the ability for both parties to see each other is essential to obtaining firsthand and candid responses. This is nothing new. Prior to COVID-19, most businesses were familiar with remote conferencing. Since COVID-19, it’s become a ubiquitous part of our industry and standard business practice.

Third-Party support

The final key to conducting a successful remote audit is having a support technician present. In order to facilitate the remote audit, the technician is there to manage the communication technology. This is also done remotely, allowing the auditor and the site staff to focus on the audit without distraction or delay from some of the challenges often encountered by the use of technology. Having a third-party present during the entire process provides another layer of security and reassurance. The technician would be aware of everything that is happening and can further certify and guarantee that the audit was conducted securely and that there is no potential for inappropriate or accidental disclosure of proprietary information.

Conclusions

Remote auditing is not only a viable alternative to on-site audits but with the proper utilization of technology, remote auditing could become a new cost-saving industry standard. As with any audit, technology should enhance the audit, enabling a seamless process from start to finish.


About the author

Peter Miller is the President of Dynamic Compliance Solutions, Inc. He has been involved in the Pharmaceutical and Medical Device Quality and Compliance industry for over 30 years, helping clients with quality and regulatory compliance-related issues, business process analysis, and implementing innovative compliance solutions for a diverse set of Life Science clients.

To learn more about conducting a remote audit, please visit DCSRACK.com

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