Sapio Sciences, the science-aware™ lab informatics platform, introduced the Sapio GMP (Good Manufacturing Observe) LIMS for laboratories requiring unparalleled flexibility to fulfill manufacturing compliance requirements. The brand new Sapio GMP LIMS resolution addresses {industry} functions in biotechnology, pharmaceutical, scientific analysis and diagnostics, meals and beverage, chemical, and environmental testing.
Constructed on Sapio Sciences’ industry-leading lab informatics platform, the new GMP resolution features a high quality management laboratory data administration system (QC LIMS), environmental monitoring applications, and stability administration. The answer addresses relevant regulatory necessities, information integrity, and safety to make sure international compliance and gives take a look at and outcome administration, documentation, sturdy audit trails, and digital signatures.
As a part of Sapio Sciences GxP options, together with Good Laboratory Observe (GLP) and Good Scientific Observe (GCP), the brand new GMP providing automates and streamlines high quality management processes, reduces guide errors, enhances total accuracy, and gives end-to-end traceability and audit trails, and improves total working high quality. Along with GMP, the answer can also be 21 CFR Half 11 and EU Annex-11 compliant.
“Manufacturing laboratories face growing compliance calls for, that are poorly served by at this time’s rigid and poorly built-in high quality management software program merchandise,” mentioned Kevin Cramer, founder and CEO of Sapio Sciences.
“By adopting Sapio GMP LIMS, manufacturing laboratories can shortly combine, configure, and automate their distinctive compliance necessities to the exact nature of their merchandise, processes, and group. This ensures the QC compliance processes are shortly adopted, robustly managed, and reduce guide, error-prone exercise.”
Kevin Cramer, founder and CEO of Sapio Sciences.
Kevin continued, “Sapio Sciences’ lab informatics platform is essentially the most versatile platform available in the market, and our out-of-the-box GMP resolution brings environmental and stability administration capabilities instantly into the platform, making it superb for high quality labs, and giving prospects the traceability, accountability, and information integrity to fulfill regulatory compliance and guarantee high quality manufacturing.”
The three key components of the brand new Sapio GMP LIMS embody:
Sapio QC LIMS: streamlines materials and product administration with configurable dashboards, drug product registration, and batch creation. It automates sampling plans and QC testing workflows, making certain environment friendly batch and pattern administration. The module integrates analytical testing with automated move/fail determinations, capturing detailed information for every pattern. Moreover, it generates Certificates of Evaluation (COA) and Launch with digital signature assist, complying with rules equivalent to 21 CFR Half 11, and ensures complete documentation by embedding COAs throughout the launch certificates.
Sapio Environmental Monitoring Applications: enhances website, tools, and storage administration by monitoring and organizing manufacturing websites, tools particulars, and hierarchical storage models. It facilitates routine and advert hoc testing plan setup with AI-powered plan era from website photographs and customizable templates. The module streamlines measurement scheduling, outcome recording, and automated analysis towards predefined standards, making certain complete traceability. Knowledge visualization and evaluation options embody interactive pattern charts, warmth maps, and superior analytics for figuring out traits and potential points, offering a strong resolution for environmental monitoring.
Sapio Stability Administration: streamlines the setup and execution of stability research. It permits the initiation of research from drug product batches, defines research sorts, storage situations, and durations, and tracks pattern assignments. The module helps detailed research parameters and time level setup, robotically creating testing requests. It schedules and data pattern testing outcomes, robotically evaluating them towards predefined standards for complete traceability. Reporting options embody configurable abstract stories, pattern evaluation, degradation sample identification, and shelf-life projections. Integration with the ELN ensures seamless entry to check protocols, stories, and experimental information.
The GMP LIMS resolution is constructed on the Sapio Platform. This versatile, configurable, and scalable lab informatics platform can meet the dynamic necessities of small QC labs to massive course of manufacturing operations in a number of industries, together with pharmaceutical and biotech, scientific analysis and diagnostics, meals and beverage, environmental testing, chemical compounds, and petrochemicals.
Sapio GMP LIMS is offered now.
