Automation in GMP labs is limited primarily because available options rely on customized systems for tasks like sample preparation. While core automation technology is well-established and used in fields such as R&D and diagnostics, these systems are typically standardized for narrow workflows (e.g., DNA extraction with specific reagents) or custom-built to meet unique lab needs. GMP labs, however, require flexible solutions to accommodate diverse methods, effectively restricting them to custom systems. Yet, custom systems demand substantial investments for project setup, method development under strict GMP standards, and extensive GAMP Category 5 validation, making them economically unviable for most GMP applications.

GAMP 5 Category 4 systems are configurable systems. These systems use standardized, pre-built software functions that can be tailored through configurations, such as setting parameters or toggling features, without modifying the underlying code. This approach minimizes validation requirements since configurations don’t alter the core software, focusing validation on intended use rather than full functional testing. As a result, Category 4 systems provide GMP-compliant flexibility with lower validation costs and faster implementation, ideal for labs needing robust automation but without the overhead of custom coding.

In contrast, GAMP 5 Category 5 systems are custom-built or heavily modified to meet unique process needs, often requiring code changes. This deep customization demands rigorous validation, including detailed functional testing and documentation, to ensure compliance and system reliability. Moreover, any modification to the system triggers a re-validation process, adding time and cost. Category 5 systems suit highly specialized processes but require significant investment in ongoing validation and documentation.

In short, Category 4 offers adaptable, compliant automation with simpler validation, while Category 5 delivers fully tailored solutions with more complex, ongoing validation efforts.

Standardization supports GAMP 5 Category 4 validation by providing a consistent, pre-qualified system framework that eliminates the need for custom coding, allowing users to configure the system without altering core software. This streamlined approach simplifies validation since much of the work—such as compliance testing and documentation—is already done by the vendor, reducing the validation scope and lowering the change control burden. Standardized systems also offer ready-to-use IQ, OQ, and FS documentation, enabling faster, more predictable implementation while maintaining GMP compliance, aligning perfectly with Category 4’s focus on efficiency and simplicity.

Standardized systems for QC in GMP labs are largely unavailable due to the highly diverse and specialized nature of QC processes, which traditionally rely on tailored workflows that differ significantly across labs and products. Standardization is particularly challenging in this context, given the wide range of variables—such as sample composition, materials, and processes—especially when using complex equipment like liquid handlers, which introduces additional technical variables and degrees of freedom.

Sciquoia addresses these challenges by offering a novel approach to a standardized automation platform under GMP that combines flexibility with compliance, allowing for diverse QC workflows through configuration rather than customization. By utilizing a parameter-driven setup, Sciquoia enables users to tailor workflows, sample types, and process variables within a pre-validated, GAMP 5 Category 4 framework, which eliminates the need for extensive re-validation. This approach reduces technical variability and risk and simplifies integration, while robust documentation and pre-configured compliance features streamline validation, making Sciquoia’s solution adaptable to the unique needs of QC labs without the cost and complexity of custom-built systems.