Preview Increasing Speed & Accuracy of Remote Audits with Modern Cloud QMS

This video provides an in-depth exploration of the challenges and best practices for conducting remote audits in the life sciences industry, particularly in the wake of the COVID-19 pandemic and the shift to virtual working environments. Featuring insights from quality experts at Merck & Co. and GlaxoSmithKline, alongside Veeva Systems, the discussion centers on how modern cloud solutions and adapted methodologies can enhance the speed and accuracy of virtual audits. The speakers delve into the practical difficulties encountered during remote audits and share lessons learned from their organizations' experiences.

Ralph Mazenko, Executive Director of Clinical Quality Assurance at Merck, highlights several key challenges. He emphasizes the loss of non-verbal communication, specifically body language, as a significant impediment in virtual settings. Technical difficulties, or "snafus," such as struggling with mute buttons or inadvertently talking over others on platforms like MS Teams or Zoom, are also cited as common issues. Furthermore, scheduling complexities, especially across different time zones, contribute to the overall difficulty. Mazenko notes that remote audits often require more time than in-person audits because it's harder to cover the same number of topics, leading to auditors working longer hours even without travel.

Marcus Massingham, Senior Director of Quality Systems at GlaxoSmithKline, expands on the technological and logistical hurdles. He points out the stark difference in documentation access between physical and virtual audits; in a physical setting, documents are readily available in a control room, whereas virtual audits necessitate an extra step for transmission, consuming valuable time. Massingham also addresses the challenges of connectivity and technology infrastructure within manufacturing or laboratory areas, which can impede attempts to conduct visual inspections or gather real-time information remotely. Both speakers underscore the need for organizations to adapt their audit plans and embrace new strategies to navigate these virtual complexities effectively.

The discussion culminates in practical recommendations for improving the remote audit experience. Key lessons learned include the importance of scheduling fewer topics per audit with more allocated time for each, incorporating regular breaks to allow participants to gather requested information, and critically, providing opportunities for teams to practice using the technology without stress before a live audit. The overarching theme is that successful remote auditing requires not just technology adoption, but also a fundamental rethinking of processes, a focus on preparation, and an understanding of the unique human and technical dynamics of virtual interactions.

Key Takeaways:

• Loss of Non-Verbal Cues: Remote audits significantly suffer from the absence of body language and other non-verbal cues, making it challenging for auditors to fully understand context and nuances, which can impact the depth and accuracy of the assessment.
• Prevalence of Technology Snafus: Basic technical difficulties, such as managing mute functions, avoiding speaking over others, or navigating virtual meeting platforms, are common and can disrupt the flow and efficiency of remote audit proceedings.
• Increased Time Allocation Required: Virtual audits inherently demand more time per topic compared to in-person audits, as information exchange, clarification, and document review processes are often slower in a remote setting.
• Auditor Workload Intensification: Despite eliminating travel, auditors frequently experience longer working days during remote audits due to the unique demands of virtual collaboration and the extended time required to complete tasks.
• Strategic Scheduling for Remote Audits: To optimize efficiency and reduce fatigue, it is advisable to schedule fewer audit topics, allocate more time for each, and incorporate regular breaks to allow participants to gather information offline or rest.
• Mandatory Technology Practice: Prior to a live remote audit, all participants should engage in stress-free practice sessions to familiarize themselves with the chosen virtual meeting platform and ensure seamless interaction and system access.
• Documentation Access and Transmission Challenges: Unlike physical audits with centralized control rooms, virtual audits introduce an additional, time-consuming step for transmitting requested documentation, which requires robust digital processes.
• Connectivity and Infrastructure Limitations: Conducting virtual inspections or gathering real-time data from manufacturing or laboratory facilities can be severely hampered by inadequate internet connectivity or insufficient technology infrastructure in those physical locations.
• Adaptation, Not Replication: Organizations must recognize that remote audit processes cannot simply mirror traditional in-person methods; they require a fundamental re-evaluation and adaptation of methodologies, scheduling, and technological support.
• Continuous Learning and Improvement: The life sciences industry is still in a learning phase regarding remote audits, emphasizing the need for ongoing evaluation, lessons learned sessions, and continuous improvement of virtual audit strategies.