Considerations for Maintaining a Validated State of Your Analyst® Software
Once the system has been validated and put into production it is important to assess the impact on maintaining the validated state of installing updates to your Analyst Software. We recommend that you
read the release notes that accompany each hotfix and determine if there are any updates that apply to your system.
If they do apply to your system, it is important to determine whether any of the updates have regulatory impact. If they do have regulatory impact, it is best to apply them. If they do not have regulatory impact, you will need to weigh the benefit of applying the updates in light of the time and effort that will be required for testing.
It is also worth noting that future hotfixes may require you to install prior hotfixes. It is especially important that updates to auditing and/or electronic signature functionality be applied since they have clear regulatory impact.
The purpose of this white paper is to describe the activities and systems that should be monitored or considered in order to preserve the validated status of Analyst® Software.