7 Key Takeaways: Mastering FDA Audit Preparedness  

In Mastering FDA Audit Preparedness: Streaming Compliance and Easing Site Burden, a webinar hosted by Complion, an audience poll revealed that 48% of attendees spend anywhere between 6-10 hours, on average, preparing for an audit. We have a solution for that. We caught up with clinical trial experts Amanda Lesinski, Assistant Director of Regulatory Affairs at Winship Cancer Institute of Emory University and Kalen Butcher, Senior Clinical Research Professional at the University of Cincinnati, for a conversation about their experiences and insights on FDA audits at clinical research sites.  

Our panelists discussed the role of eRegulatory solutions in solving common compliance challenges and how technology streamlines the entire process. The conversation offered practical advice, lessons learned, and valuable takeaways for sites navigating regulatory compliance. In this recap, we’re sharing seven key highlights. 

1. Preparation is Paramount

Emphasis was placed on the importance of thorough preparation for FDA audits. This could include establishing internal QA/QC processes and maintaining consistent naming conventions for documents. eRegulatory solutions support sites in preparing for audits with features that enforce filing consistency as well as naming nomenclature. Sites should also prepare SOPs and workflows that help minimize risk and prepare you more in the future. Adequate preparation also helps in building resilience against unforeseen challenges. Consistency is key to quickly finding relevant documents and reducing the administrative burden on site staff. 

2. Embrace Electronic Solutions

An increasing number of sites are shifting from paper to electronic workflows to improve data accuracy and organize compliance efforts. Paper can be messy and prone to errors while electronic solutions offer a simplified and streamlined approach to document management. “The search bar within Complion is the best invention because you can find items quickly,” adds Lesinski. 

Notably, standard shared drives may not be Part 11 compliant without specific modifications related to audit logs and access control. However, purpose-built systems for streamlining compliance boast the added value of features like electronic delegation logs and built-in functionality for monitors and electronic signatures. Moreover, detailed audit histories make the inspection process more transparent and efficient.  

3. Communication Channels are Crucial

Establishing open communication channels emerged as a critical factor, especially in remote and hybrid environments. Our panelists stressed the importance of effective communication not only within your own site, but also with sponsors. Seamless communication eliminates confusion, facilitates collaboration and ensures everyone is on the same page during an audit. 

4. Audit Duration Can Vary

The duration of FDA audits can vary based on the auditors and the complexity of the study. Butcher shared an experience of a sixandahalf-day audit, highlighting the need for flexibility in scheduling and responsiveness during the inspection period. If your site is going through an audit, the best eRegulatory provider should also be available for support should there be any glitches, technical issues or other technological concerns. 

5. Customer Service Matters

Exceptional customer service plays a pivotal role in the implementation of eRegulatory technology.  A best-in-class eRegulatory solution will instill confidence and stand out for its commitment to customer support. A technology partner that listens to feedback, addresses concerns, and provides support contributes significantly to the overall success of regulatory processes.  

An experienced customer service team ensures that users can navigate the intricacies of the technology, address any challenges, and maximize the potential of the system. Finding the right vendor to partner with, one that can be a great collaborator in the process, was highlighted as essential.  

6. Lessons Learned & Continuous Improvement

A recurring theme in the discussion was the importance of learning from each audit experience. Identifying red flags, adapting processes based on recommendations, and implementing continuous improvement strategies contribute to building a solid regulatory framework.  

7. Electronic Systems in the Post-Pandemic Era

Sites using Complion’s eRegulatory experience 5x inspection readiness, 20% increased productivity and 2x increased rate of study starts. The benefits of electronic systems became particularly evident during the pandemic. Remote work capabilities, coupled with efficient electronic processes, allowed research teams to continue their work seamlessly. Sites that have adopted Complion report as much as a 75% decrease in monitoring interactions. The ability to work remotely has extended oversight capabilities, ensuring regulatory specialists can maintain control from anywhere at any time. 

Final Thoughts

In conclusion, the key takeaways from the FDA audit preparedness webinar underscore the importance of meticulous preparation, the advantages of electronic solutions, effective communication, and a commitment to continuous improvement. As clinical research continues to evolve and become more complex, staying proactive and embracing innovative tools will be essential for navigating the challenges of clinical trial compliance.  

Read more: FDA Audit Readiness: How to Prepare & Share Faster with Monitors