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The GxP software dilemma: compliance vs. improvement

For decades, companies in GxP-regulated industries have faced a difficult choice: lock down a validated system to ensure compliance, or risk invalidation by making necessary process improvements. The traditional Computerized System Validation (CSV) model, with its massive upfront cost and effort, forces systems into a “frozen” state. This rigidity means that once a system is validated, it can’t easily adapt to evolving business needs or process optimizations. The fear of triggering a full re-validation—a process that can take months—often leads to a painful decision: either live with inefficient, outdated workflows, or revert to cumbersome, paper-based systems that are themselves a major source of compliance risk. This creates a fundamental conflict between the goals of the quality department and the operational needs of the business.

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A new paradigm for GxP software

Seal resolves this conflict. We offer a new paradigm for software in regulated environments, built on the principle that you should not have to choose between compliance and improvement.

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A living system in a validated state

Unlike traditional GxP systems that must be locked down after initial validation, Seal is designed to be a living system. It can safely evolve and adapt to your processes without compromising its validated state. For GxP systems, this means you can evolve and improve your platform in response to business needs, without the fear of invalidating the system or triggering a massive, manual re-validation effort. For non-GxP systems, it provides a robust, auditable history of changes. This is made possible by Seal’s unique architecture. Every item in Seal, from a process to a specification, is a version-controlled, self-contained object. Planned configuration changes are managed through Change Sets, which allow for formal review and approval of any modification before it goes live. This is supported by a multi-layered testing strategy, combining Seal’s built-in unit, integration, and end-to-end tests with the ability for you to add your own automated tests for your specific configuration. This integrated system is so robust that many of our customers use the Seal platform as the foundation of their Quality Management System (QMS).

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Our approach to validation

Software validation is the process of ensuring and documenting that a system is fit for its intended use. The level and formality of validation required depends entirely on the risk profile of your process.
  • For GxP (GMP, GCP, etc.) systems, validation is a regulatory necessity that follows a structured, risk-based process to ensure precision, compliance, and patient safety.
  • For non-GxP or R&D systems, validation is typically a simpler process of User Acceptance Testing (UAT) focused on ensuring the system is fit for its purpose.
The following pages detail the specific validation pathways available in Seal.
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