Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask

CHAPTER 2

PEOPLE, PROCESS, AND DOCUMENTATION

INTRODUCTION

Robust documentation systems have commonality, regardless of their structures. They result from a healthy understanding of the data and documents the company needs to control, a workable and user-friendly process, and a knowledgeable workforce that functions as a team in sustaining and growing the system. Unfortunately for some companies, document management has been perceived as an administrative function or even a filing system. Such a viewpoint has proven to be problematic, since documentation is the life blood of companies developing or producing therapeutic products. Without documentation, a company has no proof of its activities or the integrity of its products. Thus it is critical that companies allot the appropriate resources to producing and managing documentation. Such resources include people knowledgeable in document controls as well as managerial and budgetary support. With these resources, the company can build and maintain a system that functions optimally within the culture of the company. This chapter answers the following questions:

1. What exactly does the term “documentation” mean?
2. What is the purpose of documentation?
3. Why is a document system necessary?
4. How do you define what a document system actually is?
5. How does the term “informatics” differ from document management?
6. To what unit of a company does ...