Almac Clinical Services: Transforming Quality Processes & Collaboration with Vault QMS

By standardizing quality processes and extending them to external partners, a global CDMO improved efficiency, visibility, and collaboration.

Almac Clinical Services, a member of the Almac Group, is a leading contract services provider based in Northern Ireland. Quality team leaders sought to unify quality processes across people, partners, and systems. They saw a unified quality strategy as the key to improving visibility and collaboration — not only internally, amongst their 3000+ employees, but with the company’s suppliers and pharma customers.

With the shift to cloud, Almac Clinical Services saw an opportunity to more effectively connect employees, suppliers, and pharma customers by replacing multiple, disconnected systems that were in place that required extraction and manipulation of data and reporting and extending access to external collaborators. The diversified CDMO needed real-time visibility into quality data and a system that would make it easier to trend, report, and analyze Quality Events, explains Cherith Wallace, global quality systems manager, who led the company’s implementation of Veeva Vault QMS.

So far, the application has increased efficiencies and reduced manual processes. “Vault QMS has improved the efficiency and integrity of our quality processes by creating a single system and removing our reliance on email, paper, and spreadsheets,” says Wallace.

Driving the Vault QMS project was a vision of unified quality management in one global system. In addition, the team wanted to extend the offering to invite customers and suppliers into relevant parts of their processes to input responses or perform approvals, making it more efficient and all within Vault QMS.

Enabling external collaboration

Two features within Vault Quality proved crucial to helping extend the new QMS to Almac Clinical Services’ customers and suppliers:

• External collaboration, which allowed Almac Clinical Services to invite customers and suppliers into its QMS and participate in a specific task, providing them a limited view of the system based on needs and business priorities. During configuration, this feature allowed the implementation team to spell out exactly what information the external collaborator should see.
• Temporary partner accounts, which allowed Almac Clinical Services to remove friction out of the provisioning process through email, improving accessibility and data integrity, and reducing errors.Now, Almac Clinical Services users create audits and log findings directly in Vault QMS, then select a contact to collaborate externally. That external supplier or customer is invited to create an account and password to input responses directly into Almac Clinical Services Vault QMS. Once they’ve finished, their account is automatically disabled, removing all administrative overhead.

For the past several months, Almac Clinical Services has been using these features within Vault QMS to manage supplier audits. The new approach is intuitive, and suppliers find it easy to use without any additional training. “We’ve streamlined our processes and improved efficiency and data integrity by having partners enter data once, directly into Vault QMS,” says Wallace.

Almac Clinical Services has implemented this temporary account feature into its audit process, and plans to use it for deviation, complaints and CAPAs in the future, reserving alternative options for partners that don’t wish to work within its QMS. For Wallace and her team, the Vault QMS has improved the quality team’s ability to collaborate, both within and outside of Almac Clinical Services’ boundaries, while driving efficiencies and removing manual processes. “I’m excited to see how this product is going to evolve,” she says.

Watch this video to learn how external collaboration capability in Vault QMS takes the friction out of audits.