Sapio Sciences , the science-aware™ laboratory informatics platform , announced that its unified research and clinical informatics platform has been validated to meet quality guidelines and good practice regulations. The validation includes all components of Sapio’s no-code platform, which combines the electronic laboratory notebook (ELN), the laboratory information management system (LIMS) and a scientific data cloud in one system, including all applications and the cloud environment hosted by Sapio.
GxP refers to quality guidelines and regulations applicable to various industries, including pharmaceutical and biotech companies as well as contract development and manufacturing companies (CDMOs) served by Sapio’s platform. When laboratories operate in environments subject to GxP compliance, they must ensure that all of their processes, including how they use software to manage, store and analyze data, are reliable, reproducible and of high quality. Through these regulations, laboratories demonstrate that their work and products meet high standards of quality, safety and effectiveness. Sapio’s software can be used safely in environments that must comply with regulations such as GCP (Good Clinical Practices), GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices).
In addition to validating its software, Sapio has also developed a premium validation package for its customers. The package provides access to Sapio’s GxP basic documentation through a subscription service. A validation starter pack is also available.
“Working with GxP validated systems saves companies time and money and allows them to leverage a solid foundation and focus on documenting and validating their truly unique and innovative processes,” said Kevin Cramer, founder and chief executive officer of Sapio Sciences. “As more laboratories need to demonstrate compliance with GxP guidelines, it is essential that vendors like Sapio support them with systems that provide validated processes from the start.”
In addition to the ability to work under GxP, Sapio’s ELN and LIMS applications achieved ISO/IEC 27001:2013 accreditation on August 23, 2023 , a SOC 2 Type II test for the period November 1, 2022 successfully completed by June 30, 2023 and generated a HIPAA Type 1 report as of June 30, 2023. Sapio’s safety
Sapio Sciences is on a mission to improve lives by accelerating discovery. And because science is complex, Sapio makes technology simple. Sapio is a global company offering an all-in-one Science-aware™ laboratory informatics platform that combines cloud-based LIMS, ELN and Jarvis data solutions. Sapio serves some of the largest global and niche brands, including biopharma, CROs and clinical diagnostic laboratories in the areas of NGS genome sequencing, bioanalysis, bioprocessing, stability, clinical, histopathology, drug discovery and in vivo studies. Customers love Sapio’s platform because it is robust and scalable and can be quickly adapted to individual requirements thanks to the no-code configuration.
SOURCE: Businesswire