A Novel Approach to Validation in the Pharma Industry

Pharmaceutical quality management systems have fundamentally remained consistent over decades, despite substantial technological advancements. Core principles such as change control, deviation management, and product complaint handling have endured, rooted firmly in government regulations and established frameworks like Deming’s Plan-Do-Act-Check model. Buhlmann recounted his early career in the industry 35 years ago, characterized by basic computer tools and minimal networking capabilities. Fast forward to today, technology significantly enhances operational efficiency but the foundational principles persist.

Historically, manufacturing processes involved manual operations, such as physically cranking tablet presses, that required intensive labor and were susceptible to human error. Gradually, these manual systems gave way to semi-automated and eventually fully automated processes, leveraging integrated PLCs and SCADA systems. This progression drastically improved efficiency, reliability, and traceability in pharmaceutical operations.

Despite these technological leaps, human oversight and intervention have not diminished in importance. Quality management still relies heavily on human expertise to oversee complex processes, manage deviations, and ensure compliance with stringent regulatory standards. Therefore, while technology has advanced, the reliance on human judgment and decision-making in quality management remains unchanged.

Validation processes within pharmaceutical manufacturing traditionally relied on rigid waterfall methodologies, entailing extensive documentation like validation plans, requirement specifications, functional risk assessments, and rigorous testing protocols. Buhlmann explained that these processes, while thorough, often became cumbersome, slow, and inflexible, delaying the operational deployment of critical systems. In his words, the process is "goes on forever and everybody’s waiting for validation to finish so we can start to make product.”

Recognizing the inefficiencies of waterfall methodologies, companies attempted to adopt Agile approaches, characterized by iterative cycles and rapid prototyping. However, Buhlmann observed that Agile methodologies frequently replicated traditional validation elements, merely changing the artifacts of the process rather than fundamentally reshaping it. Documentation-heavy practices persisted, only now encapsulated in Agile-specific tools like user stories.

Even efforts like the FDA's Computer Software Assurance (CSA) initiative that aimed to reduce validation burdens by taking a risk-based approach fell flat. Despite its goals, the end result closely resembles the work required in traditional validation processes, with minimal improvements.

AstraZeneca’s answer is the Tulip Lifecycle Solution. When AstraZeneca first adopted Tulip and colleagues asked him to “validate the platform,” Buhlmann challenged them: “If you have no apps on it, what’s the intended use?”.

Working alongside implementation partner FactoryTalk, his team used Tulip to build a solution capable of validate other Tulip apps. The result is a suite of twelve interconnected apps that automate every step—from initial demand triage through testing and e-signed release. One global SOP governs the process, and context-sensitive instructions surface directly inside each app, ensuring “consistency from cradle to grave.”

TLS categorizes each request based on risk and scales the validation workload accordingly. A simple form conversion might record three test steps and close in hours, while a higher-risk app that impacts production on the shop floor still receives full scrutiny. Because frontline engineers own both the application and its validation artifacts in the same interface, TLS empowers citizen developers and quality personnel to innovate without drowning in paperwork. As Buhlmann puts it, “Tulip can do what they say they do. You can build apps quickly—and it worked”

This shift in validation strategy showcases the power of innovative thinking in improving pharmaceutical operations. TLS proves that strategic digital transformation can meet stringent quality requirements while enabling rapid adaptation and continuous improvement in an industry that is typically slow to adopt new technology.