How to Collaborate with Customers and Suppliers

This video provides an in-depth exploration of how Forge Biologics, a Contract Development and Manufacturing Organization (CDMO), leverages Veeva Vault to enhance and streamline collaboration with its external partners, specifically suppliers and customers. The discussion centers on the strategic implementation of Veeva Vault's external user accounts and security management features to create a robust, compliant, and easy-to-use system for managing critical quality processes. Forge Biologics recognized the necessity of establishing a strong supplier quality management program early on, not only for their internal therapeutics pipeline but also to effectively serve their clients, emphasizing the criticality of supply chain integrity in the life sciences sector.

The core methodology discussed involves configuring specific controls within Veeva Vault to enable controlled access for external users. By utilizing external user licenses, Forge Biologics grants suppliers the ability to access and interact with specific quality records, such as Supplier Corrective Action Requests (SCARs) or external audit documentation. This approach ensures that collaboration is built on a sustainable process that is both robust for regulatory purposes and user-friendly for the suppliers themselves, facilitating seamless communication and resolution of quality issues.

Furthermore, the same external user functionality is extended to clients (customers) of the CDMO. This allows clients to gain visibility into critical processes managed within Forge’s Veeva Vault system. Specific client access use cases include monitoring document control, reviewing change control records, and participating in issue escalation processes, particularly as part of deviation management. This centralized approach, which Veeva Systems notes has been a long-standing vision, positions the CDMO as a central hub where all interested parties—suppliers, the CDMO, and customers—can collaborate within a single, regulated system, making interactions smoother and more seamless across the entire value chain.

The discussion highlights the strategic advantage of using a unified platform like Veeva Vault to manage these complex, regulated interactions. By bringing suppliers and customers into their system, Forge Biologics ensures that all partners are working with the same controlled data and processes. This integration minimizes friction points, accelerates resolution times for quality events (like deviations or audits), and ultimately strengthens the collaborative relationships essential for successful end-to-end development and manufacturing services in the highly regulated pharmaceutical industry.

Key Takeaways:

• Strategic Supplier Quality Management: Implementing a robust supplier quality management program early is critical for CDMOs, benefiting both internal therapeutic pipelines and client services, underscoring the importance of supply chain integrity.
• Veeva Vault as a Collaboration Hub: Veeva Vault can be strategically configured to serve as a central collaboration platform, integrating the CDMO, its suppliers, and its customers into a single, regulated environment.
• Leveraging External User Licenses: Utilizing external user licenses within Veeva Vault is the mechanism for granting controlled access to partners, ensuring security management while facilitating necessary collaboration.
• Controlled Access for Suppliers: Suppliers are granted access to specific quality records, such as SCARs (Supplier Corrective Action Requests) and external audit documentation, enabling them to directly interact with and resolve quality issues within the CDMO's system.
• Client Visibility into GxP Processes: CDMOs can extend the same external user functionality to clients, allowing them visibility and participation in critical GxP processes like document control, change control, and issue escalation related to deviations.
• Sustainability and Ease of Use: Successful collaborative relationships with suppliers require building processes that are not only sustainable and compliant but also easy for the external users to adopt and utilize, maximizing system adoption and efficiency.
• Seamless Collaboration in Regulated Environments: Integrating external partners into the Vault system eliminates the need for disparate communication methods, making collaboration on regulated activities (like audits or deviations) significantly smoother and more seamless.
• End-to-End Service Optimization: For CDMOs offering end-to-end development and manufacturing services, centralized collaboration tools are essential for managing the complexity of multiple supply chains and client requirements efficiently.
• Minimizing Friction Points: Centralizing quality management and collaboration within a single system reduces friction points typically associated with external communication, accelerating the resolution of quality events and compliance issues.
• Security and Configuration are Paramount: The success of external collaboration hinges on the careful configuration of controls and security settings within Veeva Vault to ensure that partners only access the specific records relevant to their role, maintaining regulatory compliance and data integrity.

Tools/Resources Mentioned:

• Veeva Vault: The primary platform discussed, utilized for managing quality processes, document control, and external collaboration.
• Veeva Vault External User Licenses: The specific feature enabling controlled access for non-internal personnel (suppliers and customers).

Key Concepts:

• CDMO (Contract Development and Manufacturing Organization): An organization that provides comprehensive services from drug development through manufacturing on a contract basis for pharmaceutical and biotech companies.
• Supplier Quality Management Program: A formal system used to ensure that materials and services provided by external suppliers meet specified quality and regulatory standards (GxP).
• SCAR (Supplier Corrective Action Request): A formal request issued to a supplier detailing a non-conformance and requiring the supplier to investigate the issue and propose a corrective action plan.
• Deviation: Any departure from an approved instruction, procedure, or established standard; managing deviations often requires cross-functional and external collaboration for resolution and investigation.
• Change Control: The formal process used to manage and document changes to validated systems, documents, or processes to ensure regulatory compliance and prevent unintended consequences.