Gaining Transparency with Remote Audits at ICON plc

This video provides an in-depth look at how ICON plc, a major contract research organization (CRO), leveraged Veeva Vault QualityDocs to revolutionize its document control procedures, enhance audit transparency, and improve operational efficiency. The speaker, a document control associate at ICON, details the implementation process for controlling procedures, templates, and forms, emphasizing the immediate extension of system access to external stakeholders, including clients (sponsors) and subcontractors. This strategic move was designed to facilitate remote audits, eliminating the need for clients to travel to ICON offices, thereby generating significant cost savings for sponsors while maintaining high standards of quality and compliance.

The central theme revolves around achieving a higher level of quality through radical transparency and accessibility. By granting clients 24/7 remote access to their procedures, ICON provides continuous visibility into their operational standards—a level of service that clients now expect. This accessibility is crucial for audit readiness, as the system allows sponsors and clients to review essential documentation, such as Standard Operating Procedures (SOPs), templates, and forms, well in advance of scheduled study audits. This proactive approach ensures that all parties are aligned and prepared, significantly streamlining the audit process and reducing friction.

Furthermore, the implementation of QualityDocs directly addressed critical pain points experienced with ICON’s previous document management system. The primary challenges in the legacy system were poor search functionality and cumbersome reporting capabilities. With the new Veeva platform, the document control department has seen a marked decrease in complaints because employees can now locate documents much more easily. The reporting functionality has also been dramatically improved, allowing employees to generate and pull necessary reports independently, without requiring constant assistance from the document control department.

The transition to Veeva Vault QualityDocs represents a strategic shift toward self-service and decentralized information access within a regulated environment. This not only optimizes the internal workflow for the document control team but also empowers internal users and external clients alike. The ability for non-document control personnel to run their own reports enhances business intelligence and operational agility, demonstrating the platform’s value beyond simple document storage to become a true tool for quality management and audit facilitation.

Key Takeaways:

• Facilitating Remote Audits for Cost Savings: ICON successfully implemented Veeva Vault QualityDocs to enable clients and subcontractors to perform audits off-site, eliminating travel requirements and resulting in substantial cost savings for the sponsoring organizations.
• Achieving 24/7 Transparency: Providing clients with continuous, round-the-clock remote access to procedures, templates, and forms establishes a high level of operational transparency, which is now considered a key expectation from major CROs like ICON.
• Enhancing Audit Readiness: The system improves audit readiness by allowing sponsors and clients direct access to critical SOPs and documentation prior to study audits, ensuring familiarity and preparation, which is a significant operational advantage.
• Overcoming Legacy System Limitations: The new system directly resolved major challenges associated with the previous document control platform, specifically addressing poor search functionality and inadequate reporting capabilities.
• Improving Internal Efficiency via Search: The enhanced search functionality within QualityDocs has led to fewer complaints and allows employees to find necessary documents more quickly and efficiently, streamlining internal workflows.
• Empowering Self-Service Reporting: The improved reporting functionality allows employees to generate and pull customized reports independently, reducing reliance on the document control department and freeing up specialized staff for higher-value tasks.
• Strategic Value of QualityDocs: The platform is positioned not just as a document repository but as a tool that provides a higher level of quality assurance and service delivery to clients in the highly regulated life sciences sector.
• Broad Access for Stakeholders: The system was strategically rolled out to grant access not only to internal employees but also to clients and subcontractors who are off-site, highlighting the necessity of integrated access across the regulated ecosystem.

Tools/Resources Mentioned:

• Veeva Vault QualityDocs: The specific platform used by ICON plc for managing controlled documents, procedures, templates, and forms, central to audit readiness and quality management.

Key Concepts:

• Remote Audits: The practice of conducting regulatory or quality audits without the auditors needing to be physically present at the audited organization’s site, enabled by secure, remote access to controlled documentation.
• Document Control: The systematic management of documents within a regulated environment, ensuring that all procedures, forms, and templates are current, accurate, approved, and readily accessible to authorized personnel.
• Audit Readiness: The state of preparedness an organization maintains to successfully undergo regulatory or quality audits, often achieved through proactive organization and accessible documentation.

Examples/Case Studies:

• ICON plc Implementation: The video serves as a case study detailing how ICON plc, a major CRO, implemented Veeva Vault QualityDocs to manage its controlled documentation (procedures, templates, forms) and extend access to external clients and subcontractors to facilitate remote auditing.