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 ...
Life sciences face zero-tolerance production environments where only digital precision ensures compliance and operational ...
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 ...
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 ...
Pro Tip: Detailed training, reminders and team meetings can keep GMPs top of mind for employees. Although all GMPs in food manufacturing facilities are important, there are a few that everyone should ...
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 ...
The market opportunities lie in leveraging data process mapping to enhance data integrity and regulatory compliance, particularly aligning with FDA standards. There's potential in addressing gaps, ...
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 ...
SAN FRANCISCO, Jan. 11, 2012 /PRNewswire/ -- goBalto, developer of new generation web-based clinical research solutions, announced that it successfully completed a FDA 21 CFR Part 11 compliance audit ...
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