Transform Your Pharma Operations with AI-Powered Intelligence. Experience how Leucine's integrated platform brings together manufacturing, quality, and laboratory operations in one digital ecosystem. Schedule a personalized demo to see how our AI solutions can optimize your processes, ensure compliance, and drive operational excellence.
See How AI Transforms Your Shop Floor Operations.
Experience firsthand how Leucine's 10x MES digitalizes batch records, streamlines production, and provides real-time monitoring of your manufacturing operations. Schedule a personalized demo to discover how our AI-powered platform can enhance your productivity while maintaining compliance.
Experience AI-Driven Quality Management in Action.
See how Leucine's 10x QMS automates compliance workflows, streamlines change control, and ensures regulatory adherence. Schedule a demo to learn how our AI-powered platform can help you manage quality processes more efficiently while reducing compliance risks.
Discover Smart Laboratory Operations Management.
Watch how Leucine's 10x LES orchestrates your lab operations, automates documentation, and ensures data integrity. Schedule a demo to see how our AI-powered platform can accelerate your testing processes while maintaining audit-readiness.
Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.
TITLE/ COMPANY | Issue Date | Status | Details |
---|---|---|---|
Laboratory records do not include complete records of any testing and standardization of laboratory standard solutions. Exela Pharma Sciences LLC |
15 Nov 2024 | Normal | Justification: The observation directly concerns the stability and suitability of laboratory resolution solutions, which fall under the management of reagents and standards. Excerpt: There is no scientific rationale to support that a resolution solution is stable indefinitely, such as continuous monitoring nor assessment of the chromatographic behavior of this resolution solution since the initial use in 2021. View Details |
The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program. Exela Pharma Sciences LLC |
15 Nov 2024 | Normal | Justification: Proper handling of laboratory reagents and standards ensures quality testing. The observation outlines inadequate segregation and traceability, posing contamination risks. Excerpt: Laboratory reference standards ... were not segregated from reagents and test solutions to prevent possible mix-ups and contamination. View Details |
View and learn more about FDA Inspections
with our comprehensive list of resources