Companies Embrace Digital Quality Systems to Meet Manufacturing, Supply Chain Challenges

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

Novel therapies, closer collaboration spur quality management transformation

One key theme is that companies now need to have sufficient flexibility in quality management systems to accommodate both personalized medicine therapies that would benefit one patient and those made in very large quantities.

A digital quality platform was key to the successful scaling of manufacturing for Veklury, the brand name for Gilead’s antiviral remdesivir. The company, which relies on contract manufacturing for about 70% of its output, used Veeva Vault Quality Suite to onboard all manufacturing partners and collaboratively author product specs, quality agreements, and other critical documents. It also implemented a compliant digital archive of validation records. “We want to make sure we have signals to detect risks, and plan to mitigate them before they become a huge problem,” said Valerie Brown, Gilead’s senior vice president of quality assurance. (Watch Valerie Brown’s presentation.)

Diane Larson, who leads IT support of Merck’s research quality and compliance organizations, emphasized that companies must lay the groundwork before implementing digital systems. “You have to make sure that you have harmonized processes before you start this,” she said, adding that it’s also important to pick the right starting point. “We started with audit management because it was a smaller, self-contained 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 had been using separate quality systems for its manufacturing and research operations, but it came to believe that a unified approach would be better, said Larson. A new governance structure facilitated discussions between the two sides on a blended quality system and, in just 10 months, it implemented Veeva Vault QualityDocs, despite having to switch to remote work because of the pandemic.

Using modern quality systems from the start

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

Resilience, a year-old digital-first biopharmaceutical manufacturer, shared why the right technology foundation was essential to 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 let Resilience build interoperability, security, and transparency into quality and other manufacturing operations as they are established, which Menschik believes will be crucial to winning contracts to make personalized medicines. “We believe that the way to get more next-generation therapeutics coming to market is by giving innovators a standardized set of building blocks that can be easily composed together to help them achieve their goals,” he said. (Watch Elliot Menschikl’s presentation.)

Forge Biologics has its own pipeline of gene therapies and functions as a contract development and manufacturing organization (CDMO). Meghan Leonard, its senior director of quality management, shared how Vault QualityDocs and Veeva Vault Training reduced compliance risk and improved efficiency and reporting for both 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 life sciences, it was not uncommon for companies to have a person dedicated to walking a paper document around a facility for change control. “Now, in QualityDocs, we’re able to use collaborative authoring and capture all of that seamlessly,” she said, adding that the technology makes it possible to do review approval and issuance in the same day and, in the near future, to get real-time data on key performance indicators. (Watch Meghan Leonard’s presentation.)

Unifying quality management across the value stream

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

Using a single learning solution for GxP and non-GxP training

Summit attendees also got to hear how Dicerna Pharmaceuticals has created a single, efficient system for both GxP and non-GxP training

Julie Lafond, quality training manager, and Justin Rogers, associate director of quality, said that Dicerna started by embracing Vault Training for its GxP needs in 2019. But they let leaders of other, paper-based training to experience it as well. “We found that as they were exposed to Vault Training, they began to approach us about bringing their trainings online,” Rogers said. As a result, Dicerna used Vault Training for its annual adverse events session for GxP and non-GxP employees. Dicerna also created digital records of past paper-based classes so that employees who had already satisfied a training requirement would have digital proof.

“Now, as our company grows, we’ve got a fully integrated training system so that training takes place consistently throughout the company and appears in a unified manner 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 informed by data 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 meets both supply chain and manufacturing challenges.

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

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