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

By: Complion
FDA Audit Readiness

In March 2023, the FDA issued an update to its Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Draft Guidance, reflecting the agency’s acknowledgement of the advancing use of electronic records, systems and signatures in clinical trials. Accordingly, clinical research sites face increasing pressure to demonstrate adherence to stringent industry standards and regulations. With the growing transition from paper to electronic workflows, sites have been turning to eRegulatory solutions to standardize and simplify document management, and markedly improve compliance.  

In this blog, we’ll explore how eRegulatory can streamline audit readiness, accelerate time to be audit-ready and share crucial information faster, and more effectively, with monitors.  

The Challenge of Regulatory Compliance

Clinical research operates in a heavily regulated environment. According to the FDA’s draft guidance, “Compliance with FDA’s GCP regulations provides public assurance that the rights, safety, and welfare of subjects are protected, and that the clinical investigation data are credible.” One critical aspect of maintaining compliance is keeping comprehensive and organized records. 

Clinical trials generate vast amounts of data, documentation, and correspondence. Ensuring that these records are well-organized, easily accessible, and compliant with all regulations can be a daunting task. Traditionally, this has meant sifting through mountains of paper documents, managing numerous spreadsheets, and dealing with many emails. With the increasing complexity of clinical trials and the rise of electronic data, a more organized and efficient approach is needed. 

The Role of eRegulatory

eRegulatory platforms have emerged as the digital counterpart to the traditional binder used at sites for managing regulatory documents generated before, during, and after a clinical trial. This ensures adherence to industry regulations and stands as a pivotal element within the electronic Investigator Site File (eISF). These systems enable sites to centralize and digitize regulatory documentation, making it easier to manage and share information with auditors and monitors. Here’s how eRegulatory solutions can help improve audit readiness and outcomes in the monitoring process: 

Centralized Document Management:

eRegulatory allows sites to store all essential documents, including protocols, informed consent forms, regulatory submissions, and monitoring reports, in a centralized, secure repository. Sites improve compliance, and locate documents faster, because every document is automatically named and filed to the right location.  

Real-time Collaboration:

With eRegulatory, multiple stakeholders can access and collaborate on documents simultaneously. This real-time collaboration speeds up the document review process, increasing accuracy and consistency throughout the document’s lifecycle.  

Audit Trails:

Designed to meticulously record and track every single document modification, audit trails ensure transparency and accountability at every stage of a trial. By enabling quick access to specific document versions and their associated revisions, this streamlined access to comprehensive document histories allows for seamless reporting and communication with monitors. 

Integration with eTMF:

An electronic Trial Master File (eTMF) is a crucial component of clinical trials, establishing the setup, collection, storage, tracking and archival of essential clinical study documents. eRegulatory solutions often integrate seamlessly with eTMF systems, ensuring that documents and information are consistently available and synchronized across the organization. 

Electronic Signatures:

One of the bottlenecks in the regulatory process is obtaining signatures on documents. eRegulatory offers electronic signature capabilities, which substantially speeds up the approval and sign-off process. With eRegulatory, principal investigators can quickly review and sign-off on documents, wherever they are.  

Compliance with Regulatory Standards:

Best-in-class eRegulatory solutions are built to adhere to industry standards and regulatory guidelines, ensuring that your documents are always audit-ready. Sites can rest assured that data is secure and compliant with industry standards, including 21 CFR Part 11. 

Sharing with Monitors

Effective communication with clinical research associates (CRAs) is vital to ensure trials progress smoothly and in compliance with GCP guidelines. eRegulatory facilitates the sharing of essential information with monitors in several ways: 

Secure Access:

Easily share documents and data with monitors in a secure, auditable environment. Using Complion’s eRegulatory system, monitors are given secure access to specific sections of the platform, allowing them to review documents and data relevant to their role. This controlled access ensures that monitors only see what they need, protecting sensitive or confidential information.  


Real-time Updates:

With eRegulatory, monitors receive real-time updates on protocol amendments, deviations, and other critical changes. This enables them to stay informed and make timely decisions regarding trial conduct. The system tracks and timestamps document changes, ensuring that sites can demonstrate compliance during an audit. 


Remote Monitoring:

The ability to access documents and data remotely is especially valuable in a world where remote work and hybrid trials are becoming the norm. eRegulatory systems support remote monitoring and allow monitors to efficiently perform their duties without the need for physical presence.  


Efficient Queries and Responses:

CRAs often have queries or requests for clarification on trial documentation. eRegulatory streamlines the process of submitting queries and receiving responses, reducing communication bottlenecks. 

Final Thoughts

Regulatory compliance is non-negotiable. Complion Inc. is the pioneer of investigator regulatory technology, offering a comprehensive platform that simplifies document management and improves compliance. By streamlining audit readiness and enabling efficient communication with monitors, Complion’s enterprise grade eRegulatory solution empowers sites to confidently navigate an audit. 

Complion’s eRegulatory system is currently supported on over 20,000 active eISFs across 50 countries worldwide. Significantly, sites that adopt Complion report 5x inspection-readiness for an FDA audit. By embracing Complion eRegulatory, sites reduce compliance risks, improve operational efficiency, and ultimately advance the integrity of their clinical trials. 

We would love to show you how eRegulatory can make your work life easier. Let’s connect to explore how Complion transforms your audit readiness. 

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