Flexible LIMS launched

Lab informatics platform Sapio Sciences has announced the Sapio GMP (Good Manufacturing Practice) LIMS for laboratories that require 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' 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.”

 

 

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