Method Validation

[kristind858]

Hello,
We recently had a hardware failure and lost of of our data from Empower which contained validated methods We had a newer version of Empower installed and I now need to get our test methods back up and running. For the D3 method, I performed the accuracy portion of the method validation again and now I am wondering if I even needed to do that at all...??? The processing parameters (threshold, peak width, etc.) are documented from the method validation reports. Can I just re-enter these values without having to perform the accuracy? My next test I need to get up and running is the CoQ10 so I am hoping re-entering the validation processing parameters is suitable. Any suggestions would be awesome Thank you!

[kristind858]

Correction: *lost all of our data

[Consumer Products Guy]

No laboratory notebooks?

[Steve Reimer]

No backup files on a separate system/server?

[kristind858]

Hello,
Yes we have lab notebooks and print outs of all test reports and validation data. No back up files on the computer for Empower. They are corrupt. Terrible.... I know I have all the processing data information from the method validation. I should be able to enter all of this in since the method has been validated for accuracy, correct?

[kristind858]

Re-entering my validation parameters (threshold, peak width, etc) should be suitable, correct? We have our method validation print outs so we can show the matching integration parameters of our re-entered method. Any advice is appreciated

[Zoraku]

Re-entering my validation parameters (threshold, peak width, etc) should be suitable, correct? We have our method validation print outs so we can show the matching integration parameters of our re-entered method. Any advice is appreciated

If you already performed a proper method validation with a proper report that contains all of the results, data, and parameters then yes, you can just re-create the method as long as it matches all of the parameters that were validated in the report.

You've already done all the work to show those parameters and conditions with the samples you used all work as expected. You don't need to perform extra work just to create the method file in empower again.

[kristind858]

Thank you so much!! You are awesome !!!!