Bridging the Digital Divide between QA, QC and Manufacturing

Veeva Briefing Note

Axendia was recently briefed by Mike Jovanis, Vice President, Quality and Manufacturing, Jamie Crouch, Vice President, Global Marketing, and Jason Boyd, Senior Director, Vault LIMS Strategy, at Veeva. We discussed the value of connecting Quality Assurance (QA), Quality Control (QC) and Manufacturing teams in Life Sciences and eliminating siloed information and processes. The Veeva Vault Quality platform aims to “modernize quality” by unifying these functions and enabling better collaboration to improve overall efficiencies.

Unified and Connected Quality

The layers of legacy technologies that are supporting QC labs are continuing to impose a technical burden,” states Jovanis, “and despite the push for digitalization, many organizations still have appended paper-based processes. As we’ve continued to work with our customers, we are really seeing a stronger willingness to adopt something new.”

Veeva has been developing the Veeva Vault Quality platform steadily and deliberately for quite some time starting with Vault Quality Docs in 2013, then launching Vault QMS in 2016, as well as Vault Training in 2018. Since then, they’ve been working with customers to actively expand the capabilities of the Vault Quality platform, adding new products like Veeva Vault LIMS.

“We are being very collaborative with our customers and purposely sought early adopters that are manufacturing different types of products to ensure Veeva Vault LIMS would meet a range of industry requirements,” says Boyd. “These companies knew that they were facing an inflection point in digital technologies used in the lab. Rather than stay the course with legacy technologies, we helped them understand the value of taking a more transformative approach.”

Vault LIMS is unified with Vault Quality, bringing together QA and QC to improve efficiency, compliance, and right first-time execution. This delivers seamless quality workflows for processes such as accessing test method procedures, managing out-of-specification (OOS) results and lab investigations, and training qualification enabling companies to optimize QC to drive test reliability, improve accuracy, and reduce cycle times.

Addressing the Challenges in Batch Release

The batch release process in pharma involves thorough review and approval of manufacturing and quality control data to ensure that a product meets all regulatory and quality standards before it is released for distribution. The process for gathering the required information is typically cumbersome and often manual, as it requires sourcing data that reside in multiple systems. This can lead to errors, delays and inefficiencies. Veeva is achieving yet another significant milestone, fulfilling their mission to unify Quality and Manufacturing with the launch of Veeva Vault Batch Release, a solution that is designed to streamline the product release process to improve time to order fulfillment.

Aggregating data from disparate systems, including Enterprise Resource Planning (ERP), Quality Management System (QMS), and Laboratory Information Management System (LIMS), is a key feature of Vault Batch Release. “Vault Batch Release leverages customers’ investment in the Veeva ecosystem by streamlining quality, regulatory, and test data to drive faster, more confident release and market-ship decisions,” explains Jovanis. ”Vault Batch Release integrates with both Veeva applications and 3^rd party solutions within a company’s existing digital ecosystem. This creates a single location to review and execute on all batch related information.

A Cloud-First LIMS

The industry’s expectations of LIMS platforms have changed significantly in recent years, and we’ve seen this space become much less monolithic, with a growing number of new entrants offering solutions. Integration to companies’ existing digital ecosystems has become increasingly important, and life science companies are very focused on bringing in or transitioning to cloud-based solutions because of improved access to data and collaboration, as well as differing needs around IT infrastructure.

Veeva Vault LIMS is a cloud-based solution that works inherently with the other applications on the Vault Quality platform, facilitating data sharing across Quality applications and enhancing decisions around batch release in a seamless way that other commercially available LIMS applications are unable to accomplish. According to Boyd, “Veeva Vault LIMS is quick to deploy, by design, reducing IT dependency and overall costs, making it an accessible solution to both established organizations and fast-growing biotech companies.”

Understanding the Customer

We have witnessed more discrete subsegments emerge in the life science industry over the past few decades, and there are several reasons for this evolution. The types of modalities being developed have become increasingly complex, with therapeutics that often combine small and large molecules, along with a variety of conjugated and encapsulated molecules. We’ve seen investments in personalized medicine and treatments for orphan and rare diseases continue to grow as the development of blockbuster drugs for chronic diseases has plateaued.

With so many drugs coming off patent, generics companies are also busier than ever. Production lines and batch sizes have become more diversified, and manufacturers have had to be more flexible and agile to stay on top of order fulfillment and to protect margins, especially with government-negotiated prices. One of the consequences of all these trends is sustained growth in the contract development and manufacturing space.

These dynamics require technology vendors to acknowledge the differences in buyer behaviors and customer needs across pharma & biotech, contract services & generics, medtech, and consumer products, rather than lumping them all together under the heading of Life Sciences.

Ultimately, each of these groups is experiencing the same lack of integration across systems. The Veeva team is striving to create a seamless user experience that connects QA, QC, and Manufacturing, which will address each segment’s needs, regardless of their current digital ecosystem and stage of change.

In Brief

Bridging the digital divide to make data more accessible and processes more efficient continues to be an enormous challenge in the Life Sciences industry. Enabling connectivity across disparate systems is critical in this endeavor, and Veeva continues to show their commitment through their customer-centric offerings and extensive partner network. We will continue to provide updates on Veeva as they become available.

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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.