Veeva: Companies are adopting digital quality systems to address manufacturing and supply chain challenges

To succeed in complex manufacturing and personalized medicine, life science companies are embracing digital quality systems. Veeva R&D and Quality Summit speakers discussed the transition to proactive quality management and best practices for external collaboration, GxP training content, quality risk management, and collaborative authoring. Here are the main takeaways.

New Therapies and Closer Collaboration Drive Quality Management Transformation

A key theme is that companies must now have sufficient flexibility in quality management systems to accommodate both personalized medicine therapies that would benefit a patient and those manufactured in very large quantities.

A digital-grade platform has been key to manufacturing scale success for Veklury, the brand name of Gilead’s antiviral remdesivir. The company, which relies on contract manufacturing for approximately 70% of its production, used Veeva Vault Quality Suite to integrate all manufacturing partners and collaboratively create product specifications, quality agreements and other critical documents. It has also set up a compliant digital archive of validation records. “We want to make sure we have signals to spot risks and plan to mitigate them before they become a huge problem,” said Valerie Brown, senior vice president of quality assurance at Gilead. (Watch Valerie Brown’s presentation.)

Diane Larson, who leads IT support for Merck’s research quality and compliance organizations, emphasized that companies need to lay the groundwork before implementing digital systems. “You need to make sure you have aligned processes before you start,” she said, adding that choosing the right starting point is also important. “We started with audit management because it was a smaller, self-sustaining group. People saw the value that [the quality change] was starting to have and it got the energy moving.” (Watch Diane Larson’s presentation.)

Merck used separate quality systems for its manufacturing and research operations, but came to believe that a unified approach would be best, Larson said. A new governance structure facilitated discussions between the two parties on a blended quality system, and in just 10 months it implemented Veeva Vault QualityDocs, despite the shift to remote work due to the pandemic.

Use of modern quality systems right from the start

While established companies like Merck and Gilead have updated their legacy systems, emerging life sciences companies have the opportunity to embrace digital technology early on.

Resilience, a year-old digital biopharmaceutical manufacturer, explained why the right technology base was essential for its growth. Elliot Menschik, its chief digital officer, is working with Veeva to implement a standardized cloud-based infrastructure across all manufacturing facilities. This will allow Resilience to build interoperability, safety and transparency into quality and other manufacturing operations as they are implemented, which Menschik says will be crucial to winning manufacturing contracts. personalized medications. “We believe the way to bring more next-generation therapies to market is to give innovators a standardized set of building blocks that can be easily put together to help them achieve their goals,” he said. (Watch Elliot Menschikl’s presentation.)

Forge Biologics has its own gene therapy pipeline and operates as a contract development and manufacturing organization (CDMO). Meghan Leonard, its Senior Director of Quality Management, explained how Vault QualityDocs and Veeva Vault Training reduced compliance risks and improved efficiency and reporting for internal staff and external partners. (The company will soon add Veeva Vault QMS to complete the unified quality suite.)

She noted that when she started in the life sciences, it was not uncommon for companies to have a dedicated person going through a paper document in a change control facility. “Now in QualityDocs we are able to use collaborative authoring and capture all of this seamlessly,” she said, adding that the technology allows approval and issuance to be reviewed on the same day. and, in the near future, to obtain real-time data on key performance indicators. (Watch Meghan Leonard’s presentation.)

Unify quality management across the entire value stream

Understanding and managing an increasing number of quality risks has become routine for food manufacturing and other industries, but it is still a relatively new area for life sciences. AstraZeneca has made quality risks a priority by moving away from legacy systems. It adopted Vault Quality Suite to identify and control new risks and use risk data to drive continuous improvement. “The goal is a fully integrated and highly transparent system in which elements such as quality risk and change control are tightly integrated and work in concert,” said Alan Johnson, its global quality manager. (Watch Alan Johnson’s presentation.)

Use of a single learning solution for GxP and non-GxP training

Summit attendees were also able to learn how Dicerna Pharmaceuticals created a unique and effective system for GxP and non-GxP training.

Julie Lafond, quality training manager, and Justin Rogers, associate quality manager, said Dicerna started by adopting Vault Training for its GxP needs in 2019. But they also left managers of other paper-based training in do the experience. “We found that as they got exposed to Vault Training, they started contacting us to put their trainings online,” Rogers said. As a result, Dicerna used Vault Training for its annual adverse event session for GxP and non-GxP employees. Dicerna also created digital records of past paper-based courses so that employees who had already completed a training requirement had digital proof.

“Now, as our business grows, we have a fully integrated training system so that training happens consistently across the business and appears unified from a unified source,” Lafond said. . (Watch the presentation by Julie Lafond and Justin Rogers.)

Quality management must be proactive

Proactive quality management is the way of the future. It will be data informed and connected to other key systems, such as enterprise resource planning (ERP) and manufacturing execution systems (MES). A data-driven approach to quality management enables smarter, more informed decision-making, mitigates quality risks, and addresses supply chain and manufacturing challenges.

The continued adoption of digital may even move the industry towards predictive quality management in the future. As AstraZeneca’s Johnson put it, “The tougher question is, how do you change the culture of the industry?”

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