Forge Biologics Fireside Chat: Accelerating Quality Manufacturing

This video features a fireside chat with Meghan Leonard, VP of Quality Management at Forge Biologics, an emerging CDMO specializing in gene therapy manufacturing. She discusses Forge's journey in implementing Veeva Vault Quality solutions (Quality Docs, Training, and QMS) to establish a robust and compliant quality management system from its inception in 2020. The conversation highlights the critical factors for selecting a modern cloud-based QMS, the benefits realized in terms of efficiency and compliance, and strategies for maintaining speed in a rapidly innovating field while upholding strict quality standards.

Key Takeaways:

• Strategic QMS Implementation for CDMOs: Forge Biologics prioritized implementing a robust, user-friendly electronic Quality Management System (eQMS) early on, recognizing the stringent regulatory and compliance requirements inherent to being a CDMO in the gene therapy space.
• Leadership Commitment to Quality: A strong commitment from the leadership team to fostering a quality culture and making the necessary financial and operational investments in quality systems was crucial for successful adoption and perceived value, even in a startup environment.
• Key Evaluation Criteria for eQMS: Critical factors for selecting a QMS included the vendor's industry experience and reputation, minimal initial configuration and validation effort, ease of ongoing system administration, rapid implementation timeline, and a positive end-user experience.
• Efficiency and Compliance Benefits: Modern eQMS solutions like Veeva Vault enable significant improvements in staff efficiency through features like collaborative authoring and remote approvals, drastically reducing document review and issuance times compared to traditional paper-based systems. They also provide real-time data metrics and quality reporting for actionable insights and KPI tracking.
• Enhanced External Collaboration: The ability to leverage external user licenses within the QMS facilitates robust supplier quality management programs and allows clients secure access for document control, change control, and issue escalation, streamlining collaboration across the supply chain.
• Agile Implementation with Out-of-the-Box Solutions: For new or rapidly growing organizations, utilizing out-of-the-box configurations with minimal customization can accelerate QMS implementation and validation, enabling faster market access for therapies without compromising quality.