TABLE OF CONTENTS Data migration will be necessary for a number of reasons even when the application software is not changed. It is essential to consider the impact of data migration in the following scenarios every time CDS software is upgraded or changed:
Change in data processing algorithms following a software upgrade of an application
Change to use of a different software application
Change in computing environment such as operating system or computing platform
Change in data file formats
Data migration and system retirement usually occur at the end of the life cycle of any CDS. However, there are no directly stated regulatory requirements for formal system retirement with the sole exception of the 21 CFR 11 requirement17 for preservation of electronic records. However, there is now enforcement discretion under the new Part 11 guidance18 where alternative approaches are possible such as conversion to paper as discussed in Chapter 22. This chapter will look at data migration from the perspective of the theory and the practice with a case study.
Data migration can be the worst part of computerised system validation as a system generating the data will have been operational for a number of years, the data may be shared between several departments and the original staff involved with the project no longer work in the organisation. This can be compounded where there have been reorganisations within a firm and the system boundaries are different compared with the original...
