Empower restore test

jeanette

We have been asked recently by the Danish Medical Agency for performing restore test of software including Empower with a specific period (e.g. yearly). We do disaster recovery test (also a test of use of backup) during validation or other major change to the system.

How do you all deal with this and have you got similar request?

If a restore test is performed how do you best secure that everything is OK - all data can be read?

Is it all or nothing when you restore meaning all is there and OK or nothing is there? I need to understand how many projects and data to check.

We have > 5000 projects live so even it is not the biggest installation or even near - it is still a lot of projects to review for "no good" data.

Hope someone will share their experience with me on this.

BR Jeanette

MJS

I've never gotten any such request, but like you, generally have approached it within validation.  During typical backup/archivals, I rely on the project integrity test that Empower performs during the backup/restoration process to ensure all channels have been copied correctly.  It's built-in and it's covered under the Waters software validation, so we deem it low risk beyond a simple confirmation within validation.

In the instances where the test identifies a failure, I do go into the project to confirm that there are no results associated with the error.  Usually, the problem is due to a 0 Kb file being created.  It happens whenever the system preps for an injection and then fails to actually inject anything as anything from a missing vial to someone intentionally aborting just before the injection will cause this.

Empower re-runs the integrity test upon restoration as well.  So, any identified integrity errors can be tracked back to the backup test to confirm no new issues were identified.