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

CHAPTER 11

MAINTAINING THE SYSTEM

INTRODUCTION

So much emphasis is on defining and implementing a document system, but maintaining it and keeping it operating optimally is equally important. Because business models and the workforce change, the system requires careful tending so that continues to perform its critical function. Many factors can affect how a system performs: it may become burdened with files that are no longer critical; it may need to absorb new categories of documentation; or it may require allowing access to the system from remote locations. Whatever changes the company undergoes, it is likely that many will affect the system for document management. This chapter addresses managing the system over time and answers the following questions:

1. How can we continue to maintain data integrity?
2. What should we retain and archive: just paper, electronic records, or both?
3. Our new partner requires that we provide analytical test results, but can we use the public Internet to transmit them?
4. How long do validation and change control documents have to be retained?
5. How can we make sure our CROs maintain our documents compliantly?
6. When we audit our CRO's document practices, what should we look for?
7. How do you retire a computer system?
8. How do you migrate data from one system to another system?

   If a firm stops using an electronic system in favor of a different system, does it have ...