BALTIMORE– Sapio Sciences, the science-aware™ lab informatics platform, today announced that its unified platform for research and clinical informatics has been validated to comply with “good practice” quality guidelines and regulations. The validation encompasses all components of Sapio’s no-code platform that unifies electronic laboratory notebook (ELN), laboratory information management system (LIMS), and a scientific data cloud in one system, including all applications and Sapio’s cloud-hosted environment.
GxP refers to good practice quality guidelines and regulations that span various industries, including pharmaceutical and biotech companies and contract development and manufacturing organizations (CDMOs), which Sapio’s platform serves. When operating in environments subject to GxP compliance, labs must ensure that all their processes, including how they use software to manage, store, and analyze data, are reliable, reproducible, and high quality. Through these regulations, labs demonstrate that their work and products meet high standards of quality, safety, and efficacy. Sapio’s software can safely be used in environments needing to 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 foundation documentation through a subscription service. A validation starter pack is also available for purchase.
“Working with GxP-validated systems saves organizations time and money, enabling 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. “With more and more labs needing to demonstrate GxP compliance, it’s imperative that vendors like Sapio support them with systems that provide validated processes out of the box.”
In addition to being able to operate under GxP, Sapio’s ELN and LIMS applications achieved ISO/IEC 27001:2013 accreditation on August 23, 2023, successfully completed a SOC 2 Type II examination for the period from November 1, 2022, to June 30, 2023, and completed a HIPAA Type 1 report for June 30, 2023.
