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
Sapio Sciences, the science-aware™ lab informatics platform,
today announced the Sapio GMP (Good Manufacturing Practice) 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.
Built on Sapio Sciences' industry-leading lab informatics
platform, the new GMP solution includes a quality control
laboratory information management system (QC LIMS), environmental
monitoring programs, and stability management. The solution
addresses applicable regulatory requirements, data integrity, and
security to ensure global compliance and provides test and result
management, documentation, robust audit trails, and electronic
signatures.
As part of Sapio Sciences GxP solutions, including Good
Laboratory Practice (GLP) and Good Clinical Practice (GCP), 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.
“Manufacturing laboratories face increasing compliance demands,
which are poorly served by today's inflexible and poorly integrated
quality control software products,” said Kevin Cramer, founder
and CEO of Sapio Sciences. “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 organization. This ensures the QC
compliance processes are quickly adopted, robustly managed, and
minimize manual, error-prone activity.”
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.”
The three key elements of the new Sapio GMP LIMS include:
Sapio QC LIMS: streamlines material and product
management with configurable dashboards, drug product registration,
and batch creation. It automates sampling plans and QC testing
workflows, ensuring efficient batch and sample management. The
module integrates analytical testing with automatic pass/fail
determinations, capturing detailed data for each sample.
Additionally, it generates Certificates of Analysis (COA) and
Release with electronic signature support, complying with
regulations such as 21 CFR Part 11, and ensures comprehensive
documentation by embedding COAs within the release
certificates.
Sapio Environmental Monitoring Programs: enhances site,
equipment, and storage management by tracking and organizing
manufacturing sites, equipment details, and hierarchical storage
units. It facilitates routine and ad hoc testing plan setup with
AI-powered plan generation from site images and customizable
templates. The module streamlines measurement scheduling, result
recording, and automatic evaluation against predefined criteria,
ensuring comprehensive traceability. Data visualization and
analysis features include interactive trend charts, heat maps, and
advanced analytics for identifying trends and potential issues,
providing a robust solution for environmental monitoring.
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. Reporting features include
configurable summary reports, trend analysis, degradation pattern
identification, and shelf-life projections. Integration with the
ELN ensures seamless access to study protocols, reports, and
experimental data.
The GMP LIMS solution is built on the Sapio Platform. This
flexible, configurable, and scalable lab informatics platform can
meet the dynamic requirements of small QC labs to large process
manufacturing operations in multiple industries, including
pharmaceutical and biotech, clinical research and diagnostics, food
and beverage, environmental testing, chemicals, and
petrochemicals.
Sapio GMP LIMS is available now.
About Sapio Sciences
Sapio Sciences' mission is to improve lives by accelerating
discovery, and because science is complex, Sapio makes technology
simple. Sapio is a global business offering an all-in-one
science-aware™ lab informatics platform combining cloud-based LIMS,
ELN, and Jarvis data solutions.
Sapio serves some of the largest global and specialist brands,
including biopharma, CRO/CDMOs and clinical diagnostic labs across
NGS genomic sequencing, bioanalysis, bioprocessing, chemistry,
stability, histopathology, and in vivo studies.
Customers love Sapio's platform because it is robust, scalable,
and with no-code configuration, can quickly adapt to meet unique
needs.
For more information, visit www.sapiosciences.com and follow us
on LinkedIn.
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For further information, please contact: Zyme
Communications Anna Bakewell Tel: +44 (0)7801 098 242 Email:
anna.bakewell@zymecommunications.com Tim Brook Head of PR, Sapio
Sciences Tel: +44 (0)7760 766 213 Email:
press@sapiosciences.com