Sapio Sciences has launched its Good Manufacturing Practice (GMP) Laboratory Information Management System (LIMS), designed to offer unprecedented flexibility for laboratories dealing with unique manufacturing processes. The system aims to support compliance with GMP, 21 CFR 11, and EU Annex 11 standards across various sectors, including biotechnology, pharmaceuticals, and clinical research.

Key features

The Sapio GMP LIMS encompasses three primary components: a quality control LIMS, environmental monitoring programmes, and stability management. These elements are built upon Sapio’s existing lab informatics platform, which is renowned for its adaptability.

The quality control LIMS streamlines material and product management, featuring configurable dashboards and automated sampling plans. It integrates analytical testing with automatic pass/fail determinations and generates Certificates of Analysis (COA) with electronic signature support.

Kevin Cramer, founder and CEO of Sapio Sciences

Enhanced environmental monitoring

The environmental monitoring component offers comprehensive site, equipment, and storage management capabilities. It includes AI-powered plan generation from site images and customisable templates for both routine and ad hoc testing. Advanced data visualisation tools, such as interactive trend charts and heat maps, aid in identifying potential issues.

Stability studies simplified

The stability management module facilitates the setup and execution of stability studies, allowing initiation from drug product batches and supporting detailed study parameters. It automates testing requests and evaluates results against predefined criteria, offering features like degradation pattern identification and shelf-life projections.

Kevin Cramer, founder and CEO of Sapio Sciences, commented on the launch: “Manufacturing laboratories face increasing compliance demands, which are poorly served by today’s inflexible and poorly integrated quality control software products. 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 organisation.”

The Sapio GMP LIMS is part of the company’s broader GxP solutions, which include Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) offerings. This comprehensive approach aims to enhance overall operating quality in laboratory settings by reducing manual errors, improving accuracy, and ensuring end-to-end traceability.

For more information, visit: https://www.sapiosciences.com/

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