Opportunities lie in system redesign, enhancing documentation, and training to prevent human error in GMP-regulated environments. Focus on clear SOPs, tailored training, and supportive environments to ...
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. As part of Sapio ...
Lack of data integrity is the main reason for most FDA warning letters In 2017, data integrity issues were cited in 65% of all FDA warning letters. The main reason was incomplete data. In the Pharma ...
Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, manual data transcription and all too frequently ...
Title 21 CFR Part 58 provides guidance on Good Laboratory Practice (GLP) for executing non-clinical laboratory studies that support applications for research permits for Food and Drug Administration ...
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