Collaborating with Partners in Vault QualityDocs at Karyopharm Therapeutics

This video provides an in-depth exploration of how Karyopharm Therapeutics, through its associate director of QC, Maria Conklin, leverages Veeva Vault QualityDocs to manage compliant collaboration with external partners, a critical component of their externalized business model. The primary objective is to streamline the secure exchange of GxP (Good Practices) documents, ensuring efficiency and maintaining regulatory integrity throughout the manufacturing and development lifecycle. The speaker emphasizes that externalization significantly impacts quality, necessitating a robust, controlled platform for document management that moves beyond traditional, insecure methods like email and shared drives.

The core functionality discussed centers on enabling vendors to upload documents directly into the Veeva Vault platform. This approach addresses several pain points inherent in traditional external collaboration. Firstly, it dramatically improves security, as documents reside securely within the Veeva environment, and vendor access is strictly limited to the necessary scope. Secondly, it enhances efficiency by creating a single source of truth, eliminating the need to search across disparate locations (emails, shared drives). This centralized system ensures that all parties are working with the most current, controlled version of any document.

The types of content being managed are strictly GMP documents essential for pharmaceutical manufacturing and development. These include executed batch records, master batch records, data protocols, stability reports, method specifications, and various other reports. A significant benefit highlighted is the time savings associated with document retrieval; what previously took 20 minutes of searching across various internal and external sources now takes approximately two minutes, with the added assurance that the retrieved document is the correct, official version. Furthermore, the platform facilitates smoother internal communication and document flow. The final key benefit discussed is the strategic advantage of having a unified platform between QualityDocs and Regulatory Information Management (RIM). This integration eliminates content duplication and allows regulatory submissions to point directly to the controlled quality documents within the Vault, simplifying the submission process significantly.

Key Takeaways: • Strategic Externalization Requires Controlled Platforms: For pharmaceutical companies relying on external partners (CROs, contract labs) for manufacturing and development, using a regulated platform like Vault QualityDocs is essential to maintain quality and compliance, as externalization directly impacts GxP processes. • Security and Access Control are Paramount: Direct vendor upload capabilities within a secure platform like Veeva ensure that sensitive GxP documents are protected, limiting vendor access only to the content they are authorized to see, thereby mitigating risks associated with email or unsecured file sharing. • Significant Efficiency Gains in Document Retrieval: The transition from decentralized storage (shared drives, emails) to a centralized Vault system reduces the time required to locate the correct, most recent version of a document from approximately 20 minutes to just two minutes, freeing up valuable QC and operational staff time. • Single Source of Truth for GxP Content: Centralizing documents like executed batch records, master batch records, stability reports, and specifications ensures that both internal teams and external partners are always referencing the official, controlled version, which is critical for audit readiness and compliance. • Elimination of Content Duplication via RIM Integration: A major operational advantage is the unification of QualityDocs with the company’s RIM system; this allows regulatory submissions to directly reference the controlled quality documents, avoiding the costly and risky process of duplicating content for submission packages. • Improved Internal and External Collaboration Flow: Utilizing the built-in communication and workflow features within the Veeva platform facilitates smoother document review and approval processes, reducing friction and delays typically associated with external communication methods. • Focus on Manufacturing and Development Documentation: The platform is specifically used to manage high-stakes, regulated content necessary for product lifecycle management, confirming its role as a mission-critical system for operational quality control. • Compliance Assurance Through Version Control: Knowing that the retrieved document is definitively the "correct version" provides essential compliance assurance, especially when dealing with audit trails and regulatory inspections where version history is scrutinized.

Tools/Resources Mentioned:

• Veeva Vault QualityDocs
• Veeva Vault RIM (Regulatory Information Management)

Key Concepts:

• Externalization: The business model of relying on third-party vendors (e.g., contract labs, CMOs) for core functions like manufacturing and development, necessitating robust systems for quality oversight.
• GMP Documents: Good Manufacturing Practice documents, which include critical records like executed batch records, master batch records, and standard operating procedures, all requiring strict version control and security.
• Unified Platform: The strategic benefit of integrating systems (like QualityDocs and RIM) within the same ecosystem (Veeva Vault) to ensure data integrity, eliminate redundancy, and streamline cross-functional processes, particularly regulatory submissions.

Examples/Case Studies:

• Karyopharm Therapeutics: The company serves as the case study, demonstrating the successful implementation of Vault QualityDocs to manage collaboration with external partners involved in manufacturing and development, highlighting the operational necessity of secure, compliant document exchange.