This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).| U.S. Food and Drug Administration
About eLeaP| eLeaP®
Explore the essential principles and strategies in Quality Management to enhance customer satisfaction, streamline operations.| eLeaP®
The role of QMS software transforms Life Sciences with streamlined processes and enhanced compliance........| eLeaP®
Exploring the distinct yet interconnected roles of QA and QC in maintaining pharmaceutical product integrity and patient safety.| eLeaP®
Strategies for integrating QA/QC in clinical research to ensure data integrity and patient safety, including AI, ML, blockchain applications.| eLeaP®