Challenge: Growth Demands Meet Regulatory Complexity
A privately-held, family-owned Contract Development Manufacturing Organization (CDMO) has grown into a global leader in aseptic fill-and-finish solutions for injectable drug products. With €1 billion in annual revenue and over 7,000 employees worldwide, the pharmaceutical service provider operates on the cutting edge of pharmaceutical manufacturing.
Amid ongoing expansion—particularly in the U.S. and Germany—the company faced mounting digital transformation demands across its global quality and compliance operations. Its business model requires seamless, auditable workflows for both internal teams and external partners, especially as regulatory expectations around GxP documentation, data integrity, and electronic signatures continue to evolve.
However, the customer's existing document and quality management processes suffered from system fragmentation and manual handovers, especially when it came to legally binding signatures involving external stakeholders. These breaks not only slowed down review cycles but introduced avoidable compliance risks. The pharmaceutical service provider identified the need for a deeply integrated, GxP-compliant signature process connecting Veeva Vault QualityDocs with Docusign—delivering controlled, auditable workflows from end to end while upholding 21 CFR Part 11 expectations for electronic signatures.
Approach: A Scalable, Compliant Digital Signature Integration
USDM engaged with the company through a tailored consulting and implementation project, covering both technology enablement and compliance assurance for a phased integration of Veeva QualityDocs with Docusign.
USDM developed the connector in strategic partnership with Docusign, giving us unmatched, hands-on expertise in its architecture and performance. Because we built it, we bring deep technical insight to every integration—enabling seamless deployment, precise customer-specific configuration, and accelerated delivery. The result: faster time-to-value, streamlined implementation, and a more efficient path to compliance and operational excellence.
Project Scope
- Phase 1: Deploy USDM's proprietary middleware connector to enable Veeva's out-of-the-box connector to Docusign, supporting secure external routing via iFrames.
- Phase 2: A significant configuration and customization effort with 25+ user-specific requirements to:
- Allow selective upload of attachments.
- Support multiple Docusign environments (Standard, GMP, Demo).
- Enable envelope creation for grouping multiple related Veeva documents and automatically managing their associated workflow transitions.
- Synchronize signed renditions and their corresponding signature certificates back to their respective Veeva documents.
- Validation Services: Comprehensive authoring of validation plans, URS, traceability matrices, and PQ/OQ to include Configuration Specification and CQ (Configuration Qualification) execution support, following a GxP-aligned methodology informed by modern Computer Software Assurance (CSA) principles.
- Training and Admin Enablement: Creation of SOP-ready training materials, "Train-the-Trainer" sessions, and LMS-compatible work instructions for both GxP and non-GxP use cases.
- Cloud Assurance Subscription: Continuous regression testing and monitoring across 15+ annual release cycles (3x Veeva and 12x Docusign), reducing maintenance risks and enabling safe agility through USDM Cloud Assurance.
Results: Agility, Compliance, and Strategic Readiness
- Reduced cycle time for document signoffs: Integrated, automated workflows eliminate manual routing delays and reduce bottlenecks in both GxP and non-GxP signature processes.
- Audit-ready compliance: End-to-end traceability, lifecycle state control, and secure metadata management ensure full regulatory visibility and validation integrity.
- Scalability for future use cases: The project lays the groundwork for a roadmap expansion into areas under discussion, including eTMF, RIM, and Commercial Vault integrations.
- Operational stability and cost predictability: With USDM's middleware hosting and annual Cloud Assurance, the pharmaceutical service provider gains a predictable maintenance model and rapid release validation support.
- Digital enablement culture: The rollout empowers IT, Quality, and Manufacturing stakeholders to collaborate more fluidly, aligning with the customer's broader Industry 4.0 and data-driven innovation agenda.
By strategically addressing both current inefficiencies and future readiness, USDM enabled the pharmaceutical service provider not just to adopt a new technology but to transform a critical quality process into a robust, digital-forward methodology—turning fragmented handovers into a single compliant flow that is built to stay validated as Veeva and Docusign evolve. Explore how USDM's continuous compliance approach keeps integrated GxP systems audit-ready over their full lifecycle, or contact us to plan your own Veeva–Docusign workflow.