Sapio Sciences, a lab informatics platform provider, has debuted the Sapio Good Manufacturing Practice LIMS for laboratories endeavouring to meet manufacturing compliance standards.
The novel system has various industry applications, including biotech, pharmaceutical and clinical research.
Expanding GMP management capabilites
Built on Sapio Sciences’ original lab informatics platform, the new GMP solution incorporates a quality control laboratory information management system, (QC LIMS), environmental monitoring programs and stability management.
The solution will highlight applicable regulatory requirements, as well as ensuring data integrity and security to make sure the user is globally compliant.
It can also provide test and result management services.
The GxP solutions range
The GMP facet of Sapio Sciences’ technology is part of the GxP solution range, including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). It promises to automate and streamline quality control processes, enhance accuracy by reducing manual errors and allow end-to-end traceability, according to Sapio.
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 Founder and CEO of Sapio Sciences, Kevin Cramer. “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. This ensures the QC compliance processes are quickly adopted, robustly managed, and minimise manual, error-prone activity.”