Regulation Overview Page 2

Module 2: Part 11 Introduction

Regulation Overview

Paper and Electronic Records are not the same because Electronic Records contain more information about the data than just appear on a printed page. This information is called "meta data". Meta data may include audit trails, file properties, embedded formulas (e.g., in an Excel spreadsheet), or comments/annotations/revisions (e.g. in a Word file).

Another difference is that Electronic Records can also be changed more easily than paper records. Other parts of Part 11 address the need to track changes.

	Forum Activity: Question 1		Additional Audio Commentary
The meta data in a labeling application might include parameters that tell the system the size and orientation of a label or the type of label. The content of meta data varies by system. Think back on some of the systems that you've seen or used and identify what might likely be considered meta data for that system. Share your ideas by clicking on the Forum icon above and answering Question 1 in the Forum.