Sapio Sciences announces key new capabilities to its highly flexible, no/low-code LIMS to support laboratories that must comply with GMP, 21 CFR 11, and EU Annex 11 standards.
From Sapio SciencesReviewed by Andrea SalazarJun 25 2024 BALTIMORE, MD, June 25, 2024 — Sapio Sciences, the science-awareTM lab informatics platform, today announced Sapio GMP LIMS for laboratories that require unparalleled 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.
As part of Sapio Sciences GxP solutions, including Good Laboratory Practice and Good Clinical Practice , 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.
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.
Sapio Stability Management: streamlines the setup and execution of stability studies. It allows the initiation of studies from drug product batches, defines study types, storage conditions, and durations, and tracks sample assignments. The module supports detailed study parameters and time point setup, automatically creating testing requests. It schedules and records sample testing results, automatically evaluating them against predefined criteria for comprehensive traceability.
Manufacturing Biotechnology Diagnostics Food Laboratory QC Quality Control Research
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