In the life science industries, plenty of attention is placed in the validation of computer systems during the development of new systems and associated infrastructure.
After deploying the computer systems to support operations, the operational life of these systems initiates. This is the period of time that relevant processes are in place to run the computer system in its operational environment, monitored for satisfactory performance, and modified as part of corrective, adaptive, perfective, and preventive maintenance.
Computer systems maintenance and operations create a threat to the validated state of the systems by altering the delivered validated computer systems to meet the changing environment and/or changing needs of users.
The primary reasons a system development is not complete without the operational phase are the presence of latent defects in the computer system and changes that occur in its operational environment. Over 67% of the relative cost of the system will be accounted to the computer systems maintenance (1). A percentage of this budget will be assigned to the revalidation effort.
It is very common in the life science industry to observe that a few years after deploying a computer system, deficient operational supporting processes and/or the incorrect implementation of such processes nullify the validated state of the computer system causing remediation activities. This situation is a typical situation across multiple computer systems and provokes a remediation project across the company and adds cost to the operational life of many computer systems.
This paper provides a brief description of the typical operational life activities and processes in support to preserve the validated state of computer systems performing regulated operations.