ISPE Pharma 4.0™ Emerging Leader Hackathon: A Pressing Call for Validation 4.0 with an Integrated Approach

Traditionally, validation has been the last step in implementing new processes and systems in manufacturing operations. Missing information, inconsistent documentation, and unverifiable results often hinder an organization's ability to validate efficiently. However, these barriers to validation are no longer as daunting as they used to be.

This December, Tulip co-sponsored and led two workstreams at the ISPE Emerging Leader Hackathon at the Takeda biotech campus in Vienna—Operations and Workflows, and Quality and Validation. Participants examined creative approaches to innovating quality and validation in pharmaceutical manufacturing. Looking at the process of maintaining batch records from 2 different angles, process design and quality assurance, the two workstreams delivered a strong call to adopt Validation 4.0 best practices with an integrated approach as a way to marry digital tools and quality. In the current unpredictable business environment that requires pharmaceutical manufacturers to make the most out of their resources and minimize mistakes, a modern and effective validation process is no longer a nice-to-have but is now mission-critical.

Here are the 3 key takeaways from the Hackathon.

Digital transformation has been widely adopted in the manufacturing industry, yet pharmaceutical manufacturers continue to fall behind. The slow adoption of technology can be attributed to two main reasons: the inefficiency and ineffectiveness of the traditional validation approach and a lack of skilled validation professionals.

The current approach to validation is stuck in the 20th century with a paper-based process that focuses on deliverables. Just like in any other manufacturing process, relying on paper records is inefficient and error-prone. Some consequences of this inefficiency are long lead-time to technology deployment, delayed production, and inhibited insights and innovation. More importantly, it requires the revalidation of an entire system with each new technology—a significant barrier to innovation.

On top of that, the Quality and Validation Workstream revealed a lack of training for validation processes in the context of Pharma 4.0. Validation is an extremely experiential field—it’s not something traditionally taught in school. It takes a professional who has worked in the field to truly understand the role of the function and how it enables operations to run smoothly. Because of that, young workers in the pharmaceutical manufacturing industry are not readily familiar with how validation fits into Pharma 4.0. They will need substantial training from experienced quality professionals to start their work before they are able to find innovative ways to accelerate the validation process.

One aspect of transforming operations with the Pharma 4.0 framework is to adopt a risk-based approach to validation that is more closely aligned with the increasingly digitized process. Current validation approaches are burdensome because they focus on documents as deliverables. With a risk-based approach, the focus shifts to demonstrating fit for intended use and keeping processes controlled in order to mitigate risks. Thus, organizations can reduce the scope and increase the agility of validation compared to a document-based approach.

This shift can be done by executing an integrated validation that is truly based on intended use of the system. Traditionally, operators will follow a waterfall model in which they look at each piece of equipment and go through the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) process in a serial fashion and recording the results of the tests on paper or paper-on-glass. In a Validation 4.0 framework, organizations can opt for an integrated approach where testing a system’s fit for intended use can occur simultaneously during the system’s design and development process. With an integrated approach, organizations can validate processes while still operating at full capacity, bringing a significant increase in efficiency and minimum disruptions to the existing processes.

Learn more about how integrated validation can fuel digital transformation in Life Sciences.

In the Quality and Validation workstream, participants experimented with the integrated validation approach through the process of digitizing batch records. The participants decided to reduce risks at error-prone steps, such as collecting physical confirmation signatures and manual confirmations. Instead, they are replaced by electronic records to ensure data integrity and compliance. Automated data collection with calculations done in the background helped create a holistic control strategy that drives value along the entire manufacturing process value chain.

By reinventing the workflow of recording batch records to replace manual records and test its fit simultaneously, the team was able to prevent validation from turning into a bottleneck at the end of the operations.

An integrated validation approach requires quality assurance (QA) teams to actively engage with the engineering team in the design process. The QA team needs to identify risks and control strategies, while the engineering team needs to determine data flow, define input, output and digitize the process that can accommodate that control strategy. However, these two teams are not always walking in lockstep.

The other workstream sponsored by Tulip, Workflow and Operations, focuses on innovative ways for process engineers to design digital solutions. As participants worked together to solve the same challenge of digitizing batch records, they learned that the QA and process engineering teams were not always aligned in the steps required to integrate a new process. The primary concern for process engineers is how the system will interface with operators, not the QA team—a reflection of the ingrained traditional validation process that puts the burden of validation at the end of the operations for the QA team to handle.

To solve this problem, the engineering team must also embrace the integrated validation approach and incorporate it into their design. As a result, they will involve the quality team early on instead of working on their own to define and execute control strategies, thus simplifying the validtation process.

Utilizing Tulip’s platform and through close collaboration with the Quality and Validation workstream, the Workflow and Operations team was able to build a process for digitizing batch record that both reduces the cognitive load of operators and integrates validation without slowing down their operations. Operators can now record information at steps throughout the process with right-the-first-time electronic history records and automatically capture data from humans, machines, and sensors.

The team relied on Tulip’s composability to build their digital solutions for capturing and maintaining batch records. Composability allows engineers to build solutions for new use cases incrementally and requires validation for only the new use case, not the entire system, at each app deployment. This integrated process enables teams to deliver new functionalities through a continuous delivery and integration cycle. Its implication is multi-faceted: reducing manufacturing lead time, improving utilization of resources, and promoting quality and performance improvements over time.

Overall, the hackathon delivered a strong call for pharmaceutical manufacturers to change their mindset towards validation to catch up with the Pharma 4.0 movement. Digitizing paper forms and executing them in the traditional way is no longer enough. Instead, manufacturers need to fully embrace a modern validation approach that is based on the intended use and focuses on the value-added activity of demonstrating control instead of producing document records.

Learn how Tulip’s composable platform enables incremental design with a stepwise validation approach here.