Sapio Sciences Introduces Sapio GMP LIMS Delivering Unparalleled Flexibility for Unique Manufacturing Processes

Sapio Sciences, the science-aware™ laboratory computing platform, announced the Sapio GMP (Good Manufacturing Practice) LIMS for laboratories requiring unparalleled flexibility to meet manufacturing compliance standards. The new Sapio GMP LIMS solution addresses industrial applications in biotechnology, pharmaceutical, clinical research and diagnostics, food and beverage, chemicals and environmental testing.

Built on Sapio Sciences’ industry-leading laboratory computing platform, the new GMP solution includes a quality control laboratory information management system (QC LIMS), environmental monitoring programs and stability management. The solution addresses applicable regulatory requirements, data integrity and security to ensure global compliance and provides test and results management, documentation, robust audit trails and electronic signatures.

Part of Sapio Sciences GxP solutions, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), the new GMP offering automates and streamlines quality control processes, reduces manual errors, improves overall accuracy and provides end-to-end traceability. and audit trails, and improves the overall quality of operations. In addition to GMP, the solution also complies with 21 CFR Part 11 and EU Annex 11.

“Manufacturing laboratories face increasing compliance requirements that are poorly met by today’s inflexible and poorly integrated quality control software. » said Kevin Cramer, founder and CEO of Sapio Sciences.

“By adopting Sapio GMP LIMS, manufacturing laboratories can quickly integrate, configure and automate their unique compliance requirements based on the precise nature of their products, processes and organization. This ensures that QC compliance processes are quickly adopted, robustly managed and minimizes error-prone manual activities.

Kevin Cramer, Founder and CEO of Sapio Sciences.

Kevin continued, “Sapio Sciences’ laboratory computing platform is the most flexible platform on the market, and our out-of-the-box GMP solution brings environmental and stability management capabilities directly into the platform, making it ideal for for quality laboratories and offers customers traceability. , accountability and data integrity to meet regulatory compliance and ensure quality manufacturing.

The three key elements of the new Sapio GMP LIMS include:

Sapio QC LIMS: streamlines material and product management with configurable dashboards, pharmaceutical product registration and batch creation. It automates sampling plans and QC testing workflows, ensuring efficient batch and sample management. The module integrates analytical testing with automatic pass/fail determinations, capturing detailed data for each sample. Additionally, it generates certificates of analysis (COAs) and release with electronic signature support, in compliance with regulations such as 21 CFR Part 11, and ensures complete documentation by integrating COAs into release certificates.

Sapio Environmental Monitoring Programs: Improves site, equipment and storage management by tracking and organizing manufacturing sites, equipment details and hierarchical storage units. It makes it easy to configure routine and ad hoc test plans with AI-powered plan generation from site images and customizable templates. The module streamlines measurement planning, results recording and automatic evaluation against predefined criteria, ensuring full traceability. Data visualization and analysis features include interactive trend charts, heat maps and advanced analytics to identify trends and potential issues, providing a robust solution for environmental monitoring.

Sapio stability management: streamlines the setup and execution of stability studies. It allows studies to be initiated from drug product lots, study types, storage conditions and durations defined, and sample allocation tracked. The module supports detailed study parameters and time point configuration, automatically creating test requests. It schedules and records sample test results, automatically evaluating them against predefined criteria for full traceability. Reporting capabilities include configurable summary reports, trend analysis, degradation pattern identification, and shelf-life projections. Integration with the ELN ensures seamless access to study protocols, reports, and experimental data.

The GMP LIMS solution is built on the Sapio platform. This flexible, configurable and scalable laboratory IT platform can meet the dynamic requirements of small quality control laboratories as well as large process manufacturing operations across multiple industries, including pharmaceuticals and biotechnology, research and clinical diagnostics, food and beverage, environmental testing, chemicals and petrochemicals.

Sapio GMP LIMS is available now.