SCTbio Builds Efficient and Scalable Quality with Veeva Quality Cloud

Following its transition from a single to multi-product company, SCTbio needed a scalable quality management approach to support future growth while ensuring GMP compliance. Yet expanding its maintenance footprint was not an option and its small team had to remain focused on business priorities.

Since implementing Veeva Quality Cloud with a nimble team of just three – one business owner, one validation lead, and one admin – it is now on track to scale manufacturing while maintaining data integrity and compliance.

Building the foundation for business growth

As a contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, SCTbio requires highly controlled and inspection-ready quality processes to support its customers’ development and manufacturing programs. Realizing that legacy solutions based on SharePoint were no longer a fit for its evolving business needs, SCTbio partnered with Veeva to establish a foundation for quality management. After evaluating the market, the team chose Veeva for its cloud-first approach and strong validation support. It also valued Veeva’s guidance, rapid implementation and support throughout the implementation, which helped SCTBio to achieve its ambitious goals.

SCTbio rolled out Veeva Quality Cloud in phases, first implementing Veeva QualityDocs and Veeva QMS, before adding new features and optimizing processes.

• Phase one: Implemented QualityDocs and QMS (deviations, CAPAs, complaints, and change controls)
• Phase two: Optimized security settings, workflow routing, lifecycle tuning, and periodic reviews
• Phase three: Scaled to advanced operational modules, including asset management, material lot release, and external collaboration

Saving hundreds of hours per year

Replacing paper and email-based processes with integrated Quality Cloud workflows has resulted in significant efficiency savings. The team estimates over 340 days of manual work saved annually, equivalent to increasing operational capacity by two to three full-time staff (FTEs).

“At SCTbio, quality is fundamental to every stage of our operations and to the trust our clients place in us. Veeva Quality Cloud is deeply rooted as the main tool of our pharmaceutical quality system (PQS). It enables highly efficient, compliant, and scalable quality management while supporting the data integrity, traceability, and inspection readiness expected in cell and gene therapy manufacturing.” – Aleš Slavíček, Head of GMP Quality Assurance, SCTbio

Veeva Quality Cloud is now used daily by 80% of the organization, forming the backbone of SCTbio’s pharmaceutical quality system (PQS). The company benefits from full traceability of processes, reduced operational risk, and stronger compliance, helping maintain the quality standards and reliability expected by its cell and gene therapy clients. The platform is used extensively and has quickly become the go-to place for users to complete their quality activities.

With a scalable, fully digital quality foundation in place, SCTbio has positioned itself for continued growth without compromising on the quality its customers expect. And with Vault AI, Process Navigator, and new platform integrations planned for future adoption, the organization’s quality processes are set to further strengthen.

Discover how contract services organizations of all sizes benefit from Veeva Quality Cloud.