Phaseout and Withdrawal

The end of the operational life of a computer system needs to be managed. This chapter discusses the implications of phasing out the use of computer systems, outsource partnerships, and cloud-based services. Various system management and record management options are discussed. Key steps for all these situations include retirement of the legacy system, archiving of electronic records and documentation, migration to a replacement computer system or associated third-party service where appropriate, and final decommissioning of the legacy system. Considerations for cloud-based solutions are presented. The implications of site divestments and acquisitions by pharmaceutical and healthcare companies on the computer systems they use are also discussed. This chapter includes interspersed findings from regulatory inspections to help illustrate what is expected from regulatory authorities.