Sapio – GMP LIMS

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Pharmaceutical manufacturers must adhere to current Good Manufacturing Practice (GMP) guidelines enforced by regulators like the US Food and Drug Administration (FDA) to ensure products are produced consistently and that they meet quality standards to ensure the safety and efficacy of the final product. Sapio GMP LIMS, launched in June 2024, is a purpose-built Laboratory Information Management System designed to meet the specific needs of pharmaceutical manufacturing and other regulated industries. Developed on Sapio Sciences’ unified, AI-native informatics platform, Sapio GMP LIMS brings together quality control, environmental monitoring, stability testing, and regulatory compliance within a single, fully configurable system.

Built for highly regulated pharmaceutical manufacturing environments, Sapio GMP LIMS supports end-to-end sample traceability, electronic signatures, audit trails, and compliance with 21 CFR Part 11 and EU Annex 11. What distinguishes this solution is not just its comprehensive functionality but also its out-of-the-box readiness, unified architecture, and science-aware platform, which enable laboratories to deploy rapidly, configure without code, and operate with high efficiency.

Sapio GMP LIMS has the potential to transform how pharma manufacturers manage compliance and operational performance. It is the first commercially available GMP-focused LIMS that integrates quality control, environmental monitoring, and stability management into a single, pre-configured solution. Unlike traditional LIMS systems that require piecemeal integrations or custom development, Sapio’s unified platform natively connects all components, ensuring consistency and data integrity across all lab operations.

By centralizing all GMP data, including samples, results, test plans, and certificates, in a single platform, Sapio ensures full visibility and traceability. This not only simplifies audits and reduces compliance risk but also improves product release timelines and quality oversight.

The platform enhances reproducibility, minimizes manual error, and ensures data integrity throughout the manufacturing lifecycle. As a result, organizations can improve their quality assurance programs without slowing scientific output.

Real-World Applications
* Quality Control Management: Sapio GMP LIMS enables centralized control of QC workflows, including batch registration, material testing, inventory tracking, and result certification. Configurable dashboards support sampling plans, related compounds, and certificate generation, allowing for streamlined review and release processes.
* Electronic Batch Records (EBR): EBR functionality was added in October 2024 to enable the Sapio GMP LIMS to track every aspect of the batch manufacturing process, ensuring batch-level quality control and traceability. Key capabilities include no-code template configuration, comprehensive audit and compliance tools, and automated control from raw material management to final QC.
* Environmental Monitoring: The platform’s environmental monitoring capabilities allow for automated testing plans and continuous oversight of manufacturing sites and equipment. Monitoring data is linked to instruments and facility maps, and AI-powered schedules help ensure regulatory adherence without manual intervention.
* Stability Testing: Sapio includes a dedicated stability testing module that supports the creation of time-based testing plans, automated test requests, and interval-driven result capture. This ensures efficient tracking of product shelf life and storage compliance.
* Data Search and Analytics: The system supports advanced scientific calculations, data visualization, and full audit-ready reporting. Teams can run hypothesis tests, compare batch outcomes, or export data for further analysis—all from within a unified, validated environment.
* Integrated Scientific Tools: As part of the broader Sapio Platform, GMP LIMS connects directly to ELN and SDMS modules. Scientists can manage sample lineage, view instrument outputs, and document results using shared templates and visualizations—all governed by the same data model.

Most GMP-compliant LIMS systems require integration with separate platforms or extensive customization. Sapio GMP LIMS is delivered as an integrated solution, significantly reducing setup time, cost, and operational complexity. Its no-code environment supports rapid configuration, while its AI-native foundation enables more intelligent workflows, data entry, and decision support.

Sapio GMP LIMS brings GMP compliance, operational efficiency, and digital maturity into alignment through a unified, flexible platform designed for the real-world needs of pharmaceutical manufacturing. By combining rigorous compliance tools with AI-native technology and science-aware design, Sapio GMP LIMS helps organizations deliver quality products faster, with greater consistency, and at lower risk.