Sapio Sciences declares key new capabilities to its extremely versatile, no/low-code LIMS to help laboratories that should adjust to GMP, 21 CFR 11, and EU Annex 11 requirements.
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BALTIMORE, MD, June 25, 2024 — Sapio Sciences, the science-awareTM lab informatics platform, at present introduced Sapio GMP (Good Manufacturing Apply) LIMS for laboratories that require unparalleled flexibility to fulfill manufacturing compliance requirements. The brand new Sapio GMP LIMS resolution addresses {industry} functions in biotechnology, pharmaceutical, medical analysis and diagnostics, meals and beverage, chemical, and environmental testing.
Constructed on Sapio Sciences’ industry-leading lab informatics platform, the new GMP resolution features a high quality management laboratory info administration system (QC LIMS), environmental monitoring packages, and stability administration. The answer addresses relevant regulatory necessities, knowledge integrity, and safety to make sure international compliance and offers check and consequence administration, documentation, sturdy audit trails, and digital signatures.
As a part of Sapio Sciences GxP options, together with Good Laboratory Apply (GLP) and Good Medical Apply (GCP), the brand new GMP providing automates and streamlines high quality management processes, reduces handbook errors, enhances total accuracy, and offers end-to-end traceability and audit trails, and improves total working high quality. Along with GMP, the answer can be 21 CFR Half 11 and EU Annex-11 compliant.
“Manufacturing laboratories face growing compliance calls for, that are poorly served by at present’s rigid and poorly built-in high quality management software program merchandise, “mentioned Kevin Cramer, founder and CEO of Sapio Sciences. “By adopting Sapio GMP LIMS, manufacturing laboratories can shortly combine, configure, and automate their distinctive compliance necessities to the exact nature of their merchandise, processes, and group. This ensures the QC compliance processes are shortly adopted, robustly managed, and decrease handbook, error-prone exercise.”
Kevin continued, “Sapio Sciences’ lab informatics platform is probably the most versatile platform available in the market, and our out-of-the-box GMP resolution brings environmental and stability administration capabilities straight into the platform, making it supreme for high quality labs, and giving clients the traceability, accountability, and knowledge integrity to fulfill regulatory compliance and guarantee high quality manufacturing.”
The three key parts of the brand new Sapio GMP LIMS embrace:
Sapio QC LIMS: streamlines materials and product administration with configurable dashboards, drug product registration, and batch creation. It automates sampling plans and QC testing workflows, guaranteeing environment friendly batch and pattern administration. The module integrates analytical testing with automated move/fail determinations, capturing detailed knowledge for every pattern. Moreover, it generates Certificates of Evaluation (COA) and Launch with digital signature help, complying with laws corresponding to 21 CFR Half 11, and ensures complete documentation by embedding COAs inside the launch certificates.
Sapio Environmental Monitoring Applications: enhances website, gear, and storage administration by monitoring and organizing manufacturing websites, gear particulars, and hierarchical storage models. It facilitates routine and advert hoc testing plan setup with AI-powered plan technology from website photos and customizable templates. The module streamlines measurement scheduling, consequence recording, and automated analysis in opposition to predefined standards, guaranteeing complete traceability. Knowledge visualization and evaluation options embrace interactive development charts, warmth maps, and superior analytics for figuring out tendencies and potential points, offering a strong resolution for environmental monitoring.
Sapio Stability Administration: streamlines the setup and execution of stability research. It permits the initiation of research from drug product batches, defines examine varieties, storage situations, and durations, and tracks pattern assignments. The module helps detailed examine parameters and time level setup, mechanically creating testing requests. It schedules and information pattern testing outcomes, mechanically evaluating them in opposition to predefined standards for complete traceability. Reporting options embrace configurable abstract stories, development evaluation, degradation sample identification, and shelf-life projections. Integration with the ELN ensures seamless entry to check protocols, stories, and experimental knowledge.
The GMP LIMS resolution is constructed on the Sapio Platform. This versatile, configurable, and scalable lab informatics platform can meet the dynamic necessities of small QC labs to massive course of manufacturing operations in a number of industries, together with pharmaceutical and biotech, medical analysis and diagnostics, meals and beverage, environmental testing, chemical compounds, and petrochemicals.
Sapio GMP LIMS is offered now.
About Sapio Sciences
Sapio Sciences’ mission is to enhance lives by accelerating discovery, and since science is advanced, Sapio makes know-how easy. Sapio is a worldwide enterprise providing an all-in-one science-awareTM lab informatics platform combining cloud-based LIMS, ELN, and Jarvis knowledge options.
Sapio serves a number of the largest international and specialist manufacturers, together with biopharma, CRO/CDMOs and medical diagnostic labs throughout NGS genomic sequencing, bioanalysis, bioprocessing, chemistry, stability, histopathology, and in vivo research.
Clients love Sapio’s platform as a result of it’s sturdy, scalable, and with no-code configuration, can shortly adapt to fulfill distinctive wants.
For extra info, go to www.sapiosciences.com and comply with us on LinkedIn.
