FDA 21 CFR Part 11 vs EU Annex 11: What is the Difference?
FDA 21 CFR Part 11 and EU GMP Annex 11 address similar concerns and aim to achieve the same goals,...
Laboratory Quality Management System (LQMS)
A Laboratory Quality Management System (LQMS) refers to a set of policies, procedures, and...
ICH Q10 Pharmaceutical Quality System (and Role of an eQMS)
The ICH Q10 Pharmaceutical Quality System (PQS) is a guideline that outlines a model for an...
Annex 11: Computerized Systems (What You Need to Know)
EU Annex 11 outlines requirements for using computerized systems in the Life Science industries...
What is FDA 21 CFR Part 11? (32 Questions and Answers)
FDA 21 CFR Part 11, what is it? FDA 21 CFR Part 11 specifies the regulatory requirements used in...
21 CFR Part 11 Applicability Assessment
The 21 CFR Part 11 applicability assessment is useful in determining whether an electronic system...
21 CFR Part 11 and Training Records (What You Should Know)
The 21 CFR Part 11 is part of US Food and Drug Administration (FDA) regulations specifying...
21 CFR Part 11 Compliant Electronic Records (Guide)
21 CFR Part 11 compliant electronic records represent the digital records that comply with the...
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21 CFR Part 11 Compliance Checklist [PDF & XLS Download]
The 21 CFR Part 11 compliance checklist is a tool that can be used to evaluate the level of...
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21 CFR Part 11 Requirements [Explained]
The FDA 21 CFR Part 11 was established by the US Food and Drug Administration (FDA) to ensure the...