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

CHAPTER 6

PART 11 COMPLIANCE

INTRODUCTION

Keeping abreast of evolving requirements for the management of documents and records means understanding the regulations and the current thinking on issues. 21 CRF Part 11, Electronic Records; Electronic Signatures is, by its very nature, a vague and indefinitely worded regulation. In 1997, when it was first issued, industry wasn't quite sure how it applied. Furthermore, fears of Y2000 issues with computer systems fueled the decision to remain paper-based, and the FDA itself was tasked with learning how exactly this law applied. In more than a decade, technology has improved, industry best practices have evolved to satisfy Part 11 requirements, and the agency has further defined its expectations for compliance with this law. This chapter addresses compliance with Part 11 and industry standards. It answers the following questions.

1. What documents does the FDA use to ensure compliance?
2. Does the government offer any advice for companies?
3. Does the FDA endorse international standards?
4. Does 21 CFR 11 apply to just those systems acquired after the final rule was made effective in 1997?
5. What does the regulation mean when it uses the term “grandfathering”?
6. What are computer system industry standards?
7. If a small company still uses paper records and does so compliantly, will the FDA ever mandate that it employ electronic record keeping?
8. Does Part ...