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

CHAPTER 4

DECIDING TO GO ELECTRONIC AND FINDING A VENDOR

INTRODUCTION

Making the transition to electronic document management is inevitable for this industry. With the FDA mandating electronic submissions, and the European Union slated to do the same, e-systems will be the norm rather than the exception. Yet change can be fraught with apprehension. Humans have used paper for 3000 years, and, quite frankly, they are comfortable with it. So, going electronic can mean venturing into new territory. Yet the transition to e-system can be palatable and even rewarding, provided that the company understands how e-systems function and the advantages they offer. This chapter discusses what options are available and how to find the best vendor for the company's culture. It answers the following questions:

1. If a company wants to install an electronic record-keeping system, can it contact FDA for advice and recommendations for software?
2. Does FDA provide 21 CRF Part 11 certification of software vendors and computer systems?
3. Why aren't vendors of COTS software regulated by the FDA?
4. Since we've had paper for hundreds of years, why should we go electronic?
5. What kinds of software constitute document management applications?
6. How do these software systems for document management work, and what are the variations?
7. Are all software programs for this industry compatible only with personal computers (PCs)? ...