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

CHAPTER 5

MAKING THE TRANSITION FROM HYBRID TO VALIDATED E-SYSTEM

INTRODUCTION

Making the transition to a workable electronic system or systems may seem like an overwhelming task, but it need not be. A systematic approach works best when implementing changes in how you create and manage documents and records. Far too many firms have spent needless hours validating systems when a simple, logical approach would have gotten them to the finish line in short order. Consider the firm that is engrossed in validating software and has devoted over six months to the task, only to find that the vendor has issued an upgrade to the software. Does the validation have to stop and take the new upgrade into account? Should it continue with the validation and then do a partial revalidation of the new features afterwards? How much easier would it be to validate in short order in the first place? This chapter provides guidance on transitioning to an e-system and avoiding the pitfalls that delay or derail validation efforts. It answers the following questions:

1. Does the FDA offer any help in validating systems?
2. What is the difference between validation and qualification of software?
3. Do we have to validate our network?
4. Should we validate firmware that controls automated instruments?
5. As a young company with no documentation system in place, can we go electronic from the very beginning?
6. Can we use our ...