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Documentation errors can lead to big trouble
Documentation errors can lead to big trouble. In a recent FDA Warning Letter, a company was notified that their filing…
FDA 21 CFR Part 11 and the importance of regulatory compliance in GMP and GLP labs
The regulations for food and drugs in the United States, described in Title 21 of the Code of Federal Regulations…
11 COMPLIANCE CHECKLIST
INTRODUCTION 21 CFR Part 11 is an FDA guidance that sets out how organizations operating in the United States can…