- Sapio Sciences announces key new capabilities to its highly flexible, no/low-code LIMS to support laboratories that must comply with GMP, 21 CFR 11, and EU Annex 11 standards
Baltimore, MD: Sapio Sciences, the science-aware™ lab informatics platform, announces the Sapio GMP (Good Manufacturing Practice) LIMS for laboratories that require unparalleled flexibility to meet manufacturing compliance standards. The new Sapio GMP LIMS solution addresses industry applications in biotechnology, pharmaceutical, clinical research and diagnostics, food and beverage, chemical, and environmental testing.
Built on Sapio Sciences' industry-leading lab informatics 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 result management, documentation, robust audit trails, and electronic signatures.
As part of Sapio Sciences GxP solutions, including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), the new GMP offering automates and streamlines quality control processes, reduces manual errors, enhances overall accuracy, and provides end-to-end traceability and audit trails, and improves overall operating quality. In addition to GMP, the solution is also 21 CFR Part 11 and EU Annex-11 compliant.
“Manufacturing laboratories face increasing compliance demands, which are poorly served by today's inflexible and poorly integrated quality control software products,” 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 to the precise nature of their products, processes, and organization. This ensures the QC compliance processes are quickly adopted, robustly managed, and minimize manual, error-prone activity.”
Kevin continued “Sapio Sciences' lab informatics platform is the most flexible platform in the market, and our out-of-the-box GMP solution brings environmental and stability management capabilities directly into the platform, making it ideal for quality labs, and giving customers the traceability, accountability, and data integrity to meet regulatory compliance and assure quality manufacturing.”
The three key elements of the new Sapio GMP LIMS include:
Sapio QC LIMS: streamlines material and product management with configurable dashboards, drug 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 (COA) and Release with electronic signature support, complying with regulations such as 21 CFR Part 11, and ensures comprehensive documentation by embedding COAs within the release certificates.
Sapio Environmental Monitoring Programs: enhances site, equipment, and storage management by tracking and organizing manufacturing sites, equipment details, and hierarchical storage units. It facilitates routine and ad hoc testing plan setup with AI-powered plan generation from site images and customizable templates. The module streamlines measurement scheduling, result recording, and automatic evaluation against predefined criteria, ensuring comprehensive traceability. Data visualization and analysis features include interactive trend charts, heat maps, and advanced analytics for identifying trends and potential issues, providing a robust solution for environmental monitoring.
Sapio Stability Management: streamlines the setup and execution of stability studies. It allows the initiation of studies from drug product batches, defines study types, storage conditions, and durations, and tracks sample assignments. The module supports detailed study parameters and time point setup, automatically creating testing requests. It schedules and records sample testing results, automatically evaluating them against predefined criteria for comprehensive traceability. Reporting features 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 lab informatics platform can meet the dynamic requirements of small QC labs to large process manufacturing operations in multiple industries, including pharmaceutical and biotech, clinical research and diagnostics, food and beverage, environmental testing, chemicals, and petrochemicals.
Sapio GMP LIMS is available now.
