Eliminate System, Site, and Country Silos with Veeva Development Cloud

The video provides a detailed demonstration of how the Veeva Development Cloud unifies critical business processes across Quality, Regulatory, and Clinical functions within the life sciences enterprise, effectively eliminating system and site silos. The presentation follows a single, interconnected workflow initiated by a significant quality event: the discovery of discolored pills leading to batch destruction and halted production at a facility. The core purpose of the demonstration is to showcase the power of a connected platform to manage complex, cross-functional compliance and operational changes rapidly and efficiently.

The workflow begins with a Quality Event lodged regarding product discoloration. Upon reviewing the severity, which included visual evidence of the defect, the team agrees to launch a formal investigation. Crucially, the system immediately links the quality event data to historical supplier performance. By reviewing the supplier dashboard, the team confirms that the manufacturer, "Super Farm Manufacturing," has a history of infractions, including a previous issue with "bug parts" and hitting a threshold of four deviations, which automatically triggered a Change Control process. This seamless transition from quality investigation to supplier management highlights the platform's ability to provide empirical evidence supporting operational decisions, moving beyond anecdotal concerns.

The demonstration then transitions into the regulatory domain, focusing on the active Change Control process initiated due to the supplier's poor performance. A key change action identified is the filing of a Chemistry, Manufacturing, and Controls (CMC) variation for the US market. Within the Veeva platform, the regulatory team can view the submission status and the associated Content Plan. A significant feature showcased is the use of Vault Publishing, which enables continuous, incremental validation and publishing of submission documents. Instead of waiting until all documents are collected to begin the arduous publishing process, the system validates and publishes documents to the submission archive as they are collected. The presenters illustrate resolving a missing document placeholder (marked as "half yellow" because there was "no match document") by manually matching the correct file from the library. Once the final document is added, the system immediately generates the complete, validated eCTD format output, ready for submission to the FDA or distribution to affiliates, demonstrating an end-to-end process—from deviation to published regulatory output—completed in approximately five minutes.

Key Takeaways: • Unified Enterprise Workflow: The Veeva Development Cloud enables a single, interconnected process flow linking Quality Events, Supplier Management, Change Control, and Regulatory Submissions, ensuring that actions taken in one functional area immediately inform and trigger necessary steps in others. • Data-Driven Quality Decisions: The system facilitates moving beyond anecdotal evidence by providing immediate access to empirical data, such as the supplier dashboard, which confirmed a history of infractions (e.g., four deviations) for "Super Farm Manufacturing," justifying the initiation of a change control process. • Automated Change Control Triggering: Hitting predefined thresholds (e.g., four deviations) can automatically initiate complex processes like Change Control, ensuring proactive management of risks associated with suppliers or internal operations. • Continuous Regulatory Publishing: Vault Publishing eliminates the high-risk, time-consuming "big bang" publishing event at the end of a submission cycle. Documents are continuously and incrementally validated and published to the submission archive in the required eCTD format as they are collected. • Real-Time Submission Status: The Content Plan view provides a clear, color-coded status of submission readiness, indicating which documents are collected and successfully validated/published (green) versus those requiring manual matching or collection (half yellow/missing). • Seamless Regulatory Output Generation: The platform automatically generates the full, validated eCTD format, complete with leaf information, immediately upon the final document being added, allowing the output to be pushed directly to the gateway (e.g., FDA) or downloaded for affiliate distribution without further manual steps. • Efficiency Gains in Compliance: The demonstration highlighted the ability to execute a complex, cross-functional process—from initial quality deviation review to generating a validated regulatory submission output—in approximately five minutes, dramatically reducing cycle time and risk. • Elimination of Silos: By connecting clinical, regulatory, and quality data, the platform ensures that all relevant departments are working off the same, current information, preventing delays and compliance risks associated with disparate systems.

Tools/Resources Mentioned:

• Veeva Development Cloud: The overarching platform integrating various life sciences functions.
• Vault Publishing: The specific module responsible for automating the continuous validation and generation of regulatory submission formats (eCTD).

Key Concepts:

• Quality Event: An incident requiring investigation and documentation, such as the reported discoloration of pills.
• Change Control: A formal process used to manage and document changes to validated systems, products, or processes, often triggered by deviations or supplier issues.
• CMC Variation (Chemistry, Manufacturing, and Controls Variation): A regulatory filing required when changes are made to the manufacturing process, facility, or supply chain of a marketed drug product.
• Content Plan: A structured outline within the regulatory system detailing all required documents for a submission.
• eCTD Format (Electronic Common Technical Document): The standardized structure required by regulatory bodies (like the FDA and EMA) for electronic submissions.
• Continuous Publishing: A methodology where submission documents are incrementally validated and published in real-time as they are collected, rather than waiting for the entire package to be complete.

Examples/Case Studies:

• Quality Incident: Discoloration of pills found in the Brandner facility, leading to halted production and batch destruction.
• Supplier Risk: Super Farm Manufacturing was identified as a high-risk supplier due to a history of multiple infractions, including a previous issue with "bug parts," which triggered the Change Control process.