Shift from Myth to Risk-Based Validation: GxP Case Studies

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January 23, 2025

A healthy dialog on risk versus agility regarding GxP validation relies on us continuously challenging the status quo.

At Appsilon, we've worked on projects where GxP validation transformed from being a regulatory burden into a strategic enabler. To do this, we first needed to question outdated myths that have been hard-baked into many existing processes and then leverage a risk-based approach that can achieve compliance while also driving innovation and efficiency.

Ready to navigate GxP compliance in pharma? Our guide shows you what you need to know.

GxP validation is essential for regulatory compliance in life sciences. However, it is often misunderstood, misapplied, and unnecessarily rigid. By balancing risk with agility, we can avoid that rigidity, unblocking barriers that stifle innovation, complicate workflows, and slow progress.

I've worked with many clients across the pharmaceutical, healthcare, and life sciences sectors to address the challenges of GxP validation. Extensive experience in GxP-compliant platform engineering has shown that validation is not a fixed, one-size-fits-all concept - it's an evolving process that works best with the right balance between risk and agility.

In this article, I'll bust some common validation myths, highlight innovative approaches, and demonstrate ways to help your organization navigate the complexities of GxP-validated environments.

Looking to integrate GxP validation into your software development? Learn how starting with your Definition of Done creates a foundation for compliant, efficient delivery.

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What is Validation in the Good Software Engineering Practices (GSEP) GxP?

Validation, in the context of all the GxP regulations, ensures that systems, processes, and outputs are accurate, reproducible, traceable, and documented. It is foundational for meeting regulatory expectations and maintaining trust with patients, regulators, and stakeholders. In our case, we'll talk about the GxP Good Software Engineering Practices as they relate to the platforms that we engineer that are essential for data science.

At Appsilon, we focus on several critical principles in GxP validation, derived from established Good Software Engineering Practices (GSEP), sometimes also known as Good Programming Practices (GPP):

Accuracy: Ensuring systems produce consistent, reliable outputs.
Reproducibility: Capturing end-to-end traceability of workflows and results.
Traceability: Documenting every step, from raw data to final outputs, to meet regulatory standards.

However, we've observed that different stakeholders interpret validation differently:

Quality Teams view validation through the lens of audits, inspections, and regulatory trust.
IT Teams are process-driven and traditionally prioritize stability over agility.
End Users (e.g., data scientists and programmers) need robust, reproducible workflows and are frequently frustrated by barriers imposed by rigid validation processes.

Accommodating this divergence creates inefficiencies and underscores the need for a unified, modern approach that is tailored to your company's requirements and profile.

Want to ensure FDA compliance in your software engineering practices? Discover the 7 essential GSEP categories that will strengthen your submission process.

Myth 1: Separate Platforms Are Needed for Exploratory and GxP Work

It is a common approach to have one platform that remains GxP compliant and another that is looser and more adaptive according to the needs of data scientists and other end users. This traditional approach often results in siloed workflows, duplicated effort, and reduced efficiency.

I strongly recommend moving away from this fragmented model to where exploratory and GxP workflows coexist on the same platform. The key to making this successful is by isolating the GxP-relevant production processes rather than separating them entirely. By validating only the critical components, you can:

Have flexibility for exploratory work while ensuring compliance for GxP processes.
Reduce infrastructure complexity and eliminate redundant platforms.
Streamline workflows for greater efficiency.

Myth 2: Validation Means Long Release Cycles

Another myth is that GxP validation requires frozen environments that are infrequently updated. Many organizations still adhere to rigid release cycles - sometimes as infrequent as once a year - because they believe the validation process is too slow and resource-intensive.

At Appsilon, we've worked with industry leaders to implement risk-based validation processes that challenge this outdated way of working:

Package-Based Validation: Leverage tools like Posit Package Manager to validate specific R packages within a managed repository.
Dynamic Updates: Our clients can request updates or new packages without triggering a full revalidation of their environment.
Risk-Based Focus: Concentrate validation efforts on GxP-critical components to accelerate updates while maintaining compliance.

These align with the GSEP GxPs, which include version control, automated builds, and change control to streamline updates while maintaining an audit trail.

Seeking clarity on R package validation in pharma? Our guide breaks down the process into manageable steps.

Myth 3: Open Source Isn't Suitable for GxP Contexts

For years, concerns about regulatory compliance have prevented many organizations from fully embracing open-source tools in GxP workflows. However, the landscape has shifted dramatically and organizations have recently been adopting open-source technologies without compromising compliance. For example:

Novo Nordisk recently completed an FDA submission using R-based workflows, showcasing the viability of open-source tools in GxP.
Roche used Pharmaverse R packages in a submission, demonstrating the robustness of open-source solutions.
The R Consortium is actively collaborating with the FDA to address compliance challenges and enhance the usability of open-source tools.

Does your GxP compliance need stronger automated testing? Learn key practices for regulatory success.

Appsilon's Approach to GxP Validation: The Benefits of Risk-Based Practices

Risk-based validation is a targeted approach to ensuring compliance that focuses validation efforts on high-risk components that directly impact product safety, quality, and regulatory requirements, while allowing flexibility for non-critical areas.

By adoption risk-based validation solutions, you will gain significant advantages, including:

Efficiency: By focusing validation efforts on GxP-critical components, we help clients eliminate unnecessary overhead. This allows for faster release cycles without compromising compliance.
Flexibility: Our solutions unify exploratory and GxP workflows on a single platform. This enables:

Experimentation with non-validated tools.
Streamlined deployment of Shiny apps and other innovations.
Elimination of redundant platforms for greater operational simplicity.

Compliance with Traceability and Robustness: Appsilon integrates metadata-driven traceability into validation processes, ensuring compliance with GxP requirements. Key features include:

End-to-end documentation of workflows.
Reproducible outputs linked to specific code and data versions.

Future-Proofing: We design solutions that adapt to technological advancements. Our clients can integrate new tools seamlessly without overhauling existing workflows, ensuring they remain competitive in a rapidly evolving industry.

Is GxP compliance slowing your CI/CD pipeline? Discover how to automate while staying compliant.

The Future of GxP Validation: Risk and Agility in Balance

GxP validation is not a one-size-fits-all concept. It is an evolving practice that must balance the need for regulatory compliance with the agility required to drive innovation.

By addressing myths like the need for separate platforms, the inevitability of long release cycles, and the unsuitability of open-source tools, we've helped our clients redefine validation. Companies like Roche, Novartis, and Novo Nordisk are already leading the way, and Appsilon is proud to enable similar transformations.

Ready to reimagine your GxP validation process? Contact Appsilon today to schedule a GxP audit and discover how we can help you navigate compliance while driving innovation.

Note: This article is based on key insights from James Black's presentation at the GxP Validation Summit.

Is your GxP validation thorough enough? Check against our Definition of Done checklist for pharma teams.

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