Empower restore test

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

Answers

  • 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.
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