Rethinking GxP Validation in a Modern SAP Landscape

GxP validation has long been treated as a necessary checkpoint in regulated IT programs—something to be completed, documented, and signed off before moving forward. But as life sciences organizations accelerate digital transformation, this traditional view of validation is increasingly at odds with how modern systems are built, tested, and released.

From the perspective of an IT services provider, the tension is evident. Enterprises are adopting SAP S/4HANA, embracing automation, and shifting toward agile delivery models. Yet validation practices often remain rooted in document-heavy, manual approaches designed for a slower, more linear world. The result is not just inefficiency, but risk—risk of non-compliance, delayed releases, and strained delivery teams.

The real question organizations are now asking is not whether to modernize validation, but how to do so without compromising regulatory rigor.

Why Validation Needs a New Narrative

In many GxP environments, compliance efforts still primarily focus on assembling evidence after testing is complete. Test results are exported, documents are compiled, approvals are gathered, and audit readiness becomes a last-mile activity.

While this approach may meet minimum expectations, it creates a fragile system—one that relies heavily on human intervention and retrospective controls. As programs scale, the cracks begin to show: duplicated effort, limited transparency, and an ever-growing gap between quality engineering and validation.

Regulators, including the FDA, have increasingly signaled their openness to technology-enabled controls, provided they are well-governed and demonstrably reliable. This shift opens the door for validation to move closer to where quality is actually created.

Embedding Validation into the Testing Lifecycle

Modern GxP validation works best when it is not treated as a separate phase, but as an integral part of the testing lifecycle itself.

Instead of validating documents, organizations can validate records—such as requirements, test cases, execution results, and defects—directly within their testing tools. This approach creates a continuous chain of traceability, where approvals and controls are applied as work progresses rather than after the fact.

Products such as Tricentis Vera are designed to support this shift. By acting as a validation and governance layer across test management and automation tools, Vera enables organizations to apply GxP controls selectively and consistently, without disrupting team workflows.

When validation is embedded in this way, compliance becomes a byproduct of disciplined execution rather than a parallel administrative effort.

Making 21 CFR Part 11 Work in Practice

Electronic records and electronic signatures are often misunderstood in GxP programs. Many organizations equate Part 11 compliance with digitized paperwork—such as PDFs, scanned signatures, and electronic folders that mimic physical binders.

In reality, Part 11 is less about documents and more about control, integrity, and accountability. System-generated audit trails, secure electronic records, enforced approval workflows, and clear linkage between records and signatures are what regulators ultimately care about.

Platforms like Tricentis Vera operationalize these principles by embedding electronic records and electronic signature controls directly into testing workflows. Approvals are time-stamped, roles are enforced, and audit trails are generated automatically, reducing reliance on manual reconciliation while strengthening inspection readiness.

Standardization Without Overreach

Another challenge frequently encountered in regulated programs is inconsistency. Different tools and processes are often used for GxP and non-GxP initiatives, creating silos that increase cost and complexity.

A more sustainable approach is standardization with intent—using the same core toolchain across the application landscape while applying validation controls only where regulatory requirements demand them. In this model, Tricentis Vera acts as a centralized validation layer, enabling teams to work consistently while ensuring that GxP systems receive the appropriate level of governance.

This balance allows organizations to scale testing, automation, and performance engineering without fragmenting their validation strategy.

Lessons from the Field

YASH Technologies has seen this approach play out effectively in real transformation programs. In one such engagement with an analytical laboratory instrument and software organization serving regulated life sciences markets, embedding validation controls directly into an SAP S/4HANA testing lifecycle proved to be a turning point.

By forming a tool chain with Tricentis Vera, Tricentis qTest, Tricentis Tosca, and Tricentis NeoLoad, the organization was able to enforce GxP workflows without reverting to manual, document-driven validation. Approvals happened in context, audit trails were system-generated, and validation no longer slowed delivery.

The engagement reinforced a critical insight: when validation is designed into the system, it becomes far less visible—and far more effective.

Compliance Activity to Quality Capability

The intent of GxP regulations has always been to ensure that systems perform as intended and protect patient safety. Achieving that intent does not require heavier processes, but smarter ones.

For organizations modernizing SAP landscapes and quality engineering practices, rethinking CSV is no longer optional. Validation must evolve to support automation, agility, and global delivery models.

From YASH Technologies’ perspective, the most successful programs are those where validation is treated as a capability enabled by the right combination of process, governance, and technology. When platforms like Tricentis Vera are applied within this broader strategy, compliance stops being a constraint and starts becoming a source of confidence in the transformation journey.

• GxP Validation
• SAP
• SAP S/4HANA Cloud
• SAP S/4HANA GxP