Manual Back-up systems

[Stephen-Grayson]

For clarification I thought an inspector viewpoint would be helpful here.
Should the LIMS not be available, the site should have a system downtime plan in place which would typically include the following:
A formal procedure clearly explaining the process to follow.
Manual recording forms for testing and issues with suitable independent checks on data entry and interpretations
All component issues to be serologically cross matched
A restriction on routine testing to ensure that sufficient resource is available to address the change in practice. Typical only urgent issues will be permitted.
A means to transfer the data back into the LIMS once it is restored, found to be operating as expected and stable.
The transcription of data to populate the LIMS with manually recorded data should have an independent, preferably blind entry, check to ensure the data is confirmed to be correct

It would not be acceptable to issue components electronically if the LIMS was unavailable. The use of a periodically updated spreadsheet download would not be acceptable as it would not be contemporaneous with the system failure, and would be out of date.

Should an error in the data entry subsequently determined (e.g. incorrectly spelled name), the database management process should be used to correct the file within the LIMS as would be used for linking and merging records.

Hope this helps clear up any misunderstandings in the previous posts.

[tajhizyar19]

that's useful ! thanks!