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 |
|---|---|---|---|
| Your firm failed to exercise controls over computerized manufacturing equipment Strides Pharma Science Ltd. |
20 May 2026 | Normal | Justification: Recipe issues are rooted in system controls and validation inadequacies, affecting recipe management and data integrity. Excerpt: Obsolete recipes exist on equipment with no functional mechanism to prevent their selection. View Details |
| Appropriate controls are not exercised over computers or related systems Emcure Pharmaceuticals Limited |
15 May 2026 | Normal | Justification: Allowing analysts unrestricted viewing capabilities risks data integrity and regulatory violations. Excerpt: an analyst has permission to "view quantitation peak fields in review." View Details |
| Appropriate controls are not exercised over computers or related systems Bentley Laboratories LLC |
27 Mar 2026 | Normal | Justification: Inadequate validation of systems like pH meters and weigh balances leads to data integrity challenges. Excerpt: pH meters and weigh balances lack controls for data retention and verification. View Details |
| Appropriate controls are not exercised over computers or related systems Birchwood Laboratories, LLC |
13 Feb 2026 | Normal | Justification: Without validation, the data output from computer systems cannot be trusted for reliability and accuracy. Excerpt: Your data acquisition software and workstations have not been suitably qualified to ensure data integrity. View Details |
| Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Aurobindo Pharma Limited, Unit VII |
10 Feb 2026 | Normal | Justification: Observations detail unauthorized system operations indicative of lacking or ineffective validation processes. Excerpt: Each instrument is capable of storing up to 10,000 test reports...system will overwrite previous results. View Details |
View and learn more about FDA Inspections
with our comprehensive list of resources