ELM-153-03

The 6 Basic Rules of Controlled Documents [GDP]

Controlled documents originated by the company should follow some basic rules:

1. Uniquely Identifiable

Each document should be uniquely identifiable. Often this is through some combination of keyword / number scheme (for example, SOP-0015).

2. Unique Name & Revision

All pages should have a unique name and revision.

3. “X of Y” Format

All pages should be numbered in “x of y” format (typically in the footer), so if a page is separated, it’s easy to find where to replace it and the total number of pages is obvious.

4. Revision History

A means to understand and track the history of the document should also be present. This is often accomplished with a “Revision History” table in the document.

5. Controlled & Retrievable

Records need to be controlled and retrievable.

6. Kept Safe

Regulations require that records are kept safe from alteration or damage and you need to be able to retrieve them within a reasonable amount of.

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP