Elevating Quality Beyond Compliance: The Many Faces of Quality Transformation

Increased business complexity and new therapeutic pathways have forced the industry to redefine quality. Once a reactive and compliance-focused function, quality is becoming a strategic partner to the business, bringing new insights to boost agility.

Companies of different sizes and types are standardizing processes, unifying data, and implementing cloud-based QMS, document management, and training platforms. Designed to optimize the user’s experience, help them learn more effectively and respond more nimbly to change, these new approaches and systems enable quality teams to collaborate more effectively across internal teams and with external partners.

Sometimes companies need to “restart” their entire approach to quality management when they adopt connected digital approaches. Such was the case with medac, GmbH, a privately-owned mid-sized company focused in specialized oncology and auto-immune therapies. For decades, the company managed most of its quality systems and processes on paper or with hybrid paper-digital methods. To scale for future growth, the company needed to embrace proactive quality, consolidate data, and simplify and standardize quality systems and processes.

Connecting across functions

Partnering with Veeva, medac digitized all paper-based and hybrid processes, and replaced legacy document management, QMS, and learning management systems with the Vault Quality Suite. To improve connections between quality, CMC, and regulatory to optimize batch-release change control, it is in the process of installing Veeva’s Quality-RIM connector.

Disconnected data and manual processes make change control time-consuming for manufacturers, often leading to drug shortages and delayed availability of new treatments. One consumer healthcare leader expects the Quality-RIM connector to reduce manual processes and cut the time required for batch-release processes by between 10-30%.

The company partnered with Veeva to help its more than 22,000 employees collaborate more effectively across teams. A key part of this collaboration was connecting quality and RIM with SAP’s ERP. So far, users comment that the integration has enhanced visibility of the overall process, enabling teams to check on priority activities and their status. Overall, the company expects the connected system to make compliance easier.

Sanofi’s Consumer Healthcare Organization (CHC) has also optimized cross-functional connections, with a special focus on improving links between quality and environmental health and safety. Closer collaboration between these teams is key to improving a number of crucial functions such as quality investigations and CAPA, as well as audits, explains Letitzia Caccialupi, global QMS head.

The company worked with Veeva to harmonize quality processes across the business. Instead of merely imposing new systems, Sanofi engaged 9,000 employees at its 13 manufacturing sites and across functions to help determine priorities that would improve overall workflow and operations as well as SOPs and training. So far, the company has significantly reduced the time required for investigating quality deviations, and has not experienced a single critical or serious quality incident since it implemented the new approaches.

Addressing the needs of a digitally-aware workforce

As Nicholas Maldonado, senior vice president of quality at Gilead Sciences explains, companies must address the expectations of millennials and digital natives who need modern user experience and minimal data overload. At Gilead, he said, “We’re going from a “know-it-all” to a “find-it-all” culture. The company has rolled out a mobile plant-floor application, Veeva’s Station Manager, in its cell therapy manufacturing suites, and plans to expand its use to improve the employee experience and reduce the need for SOP training.

Ensuring that well-trained employees are ready for current and future challenges is a key priority at Gilead, especially as the company increases its work in personalized therapies. This may require more user-focused approaches to training. One biopharma that specializes in antibody-based therapies, is exploring new approaches.

The industry needs to broaden its focus on managing and tracking GxP compliance training to improve the individual learner experience and oversight of manager qualification, says the company’s associate director of process and training management. In line with this philosophy, the company is looking into alternatives to traditional content-based approaches, and considering a framework that emphasizes user needs and expectations. The company is currently evaluating the role that new applications such as Veeva’s Process Navigator, along with its MyLearning Curriculum and Curriculum Completion dashboards, might play in connecting future curricula more closely with employee roles and expectations.

Working more effectively with external partners and new subsidiaries

The industry’s continued emphasis on strategic outsourcing has resulted in a need to connect sponsor and contract partner quality systems more closely At Gilead, which outsources roughly 80% of its manufacturing and testing needs, the quality team is extending its QMS to external partners.

Some CDMOs are taking the lead in sharing quality systems with customers and suppliers. A case in point is Almac, a specialized contract services company in Northern Ireland that adopted less expensive approaches to invite its customers and vendors to collaborate.

Working closely with Veeva, Almac decides what information partners need to see and in what form. Then, using temporary user accounts and passwords, it allows customers to input information directly into the system, reducing timelines and potential data entry error. The approach has led to significant improvements in overall efficiency, says Cherith Wallace, global quality systems manager, who led the company’s implementation of Veeva Vault QMS.

Ongoing industry mergers and acquisitions have also mandated closer quality systems integration. In the past, both acquired and acquiring partners would typically wait to assess and address gaps between their quality systems. Now, companies such as Patheon are integrating their quality systems with newly acquired companies as early as possible to enable greater efficiency.

Strong change management processes, and an emphasis on clear and frequent communication, has been key to driving these initiatives, but each of these companies has succeeded in gaining support throughout their organizations. To hear more insights from these quality leaders, tune into Veeva Connect.

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