Module 2: Part 11 Introduction

Relationship to the Predicate Rules

When considering the instances in which Part 11 must be applied, you should first refer to the Predicate Rule to determine the records that are considered "required."

For example, section 58.130(e) of Good Laboratory Practices requires all data generated during the conduct of a nonclinical study be recorded and signed. If this is done electronically, then Part 11 applies.

Part 11 specifies, in detail, what must be done to those records to ensure that they are acceptable to the FDA.

Forum Activity: Question 2Forum Activity:
Question 2		 
Predicate rules specify particular requirements associated with record keeping in a regulated environment. If you've had previous experience in working with these regulations some of these will be familiar to you. Share your expertise by responding to Question 2 in the Forum. If you are not familiar with these regulations read through the responses provided by your peers and comment on your understanding of their responses.