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EZValidation™ 4: Adding Personnel and Documenting Materials

194 views · Published 3 November 2011 · 4:08 · Indexed 8 November 2026

Channel: Thermo Fisher Scientific · 2011 · Education

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This video is four of 12 that demonstrates the EZValidation Online Tool for validation and verification of molecular tests. It can also be used as training for those unfamiliar with EZValidation and AcroMetrix products by Life Technologies. This video shows you how to add personnel and document materials for your study.

Adding personnel and documenting materials.  As you're defining your study in the EZValidation™ Online tool, you'll also want to add personnel, and document materials used.  From your study home screen, you'll want to go into and scroll down to some of your materials.  Near the top of the screen is the product summary for the ordered AcroMetrix® materials.  This is automatically calculated in the first four easy steps for you in EZValidation™ tool and filled in.  But what is not filled in is the lot number and the expiration date of each of the individual AcroMetrix® products.  

For documentation purposes, this is something you'll want to fill in for your validation or your verification.  To do this, you click on the edit button.  And up opens a screen, where you can input the lot number of your materials (once you've gotten them shipped and into the lab), and the expiration date.  Again, dropdown-menu driven, so I could choose any expiration date.  And then you would click on update.  And now it has saved the new expiration date that I've input.

Likewise, you will want to document the personnel that are using the EZValidation™ tool, as well as some of the other materials that are being used.  To do that, you scroll all the way down to the bottom to the personnel and materials section.  When you initially subscribe to the EZValidation™ tool, there's usually a supervisor who is the primary administrator and has supervisor rights.  But what we found is that while the supervisor or director may want to create the studies and apply the guidelines, there are probably other people working at the bench level who are actually running the assays.

The EZValidation™ tool allows you to assign additional users—people in your laboratory, so that they can open up plate maps, print out plate maps, and print out the validation protocol, for use.  They will have limited administrative rights, so they can't change the guidelines or change acceptance criteria like the supervisor can.  

To enter a new lab tech, you would just type in the name, the title, and most important, their username.  And then you would click on the add icon, which is the addition or plus sign.  And now we've got a new person, a new operator assigned.  Likewise, with reagents, you would want to add reagents, because you want to document all of the reagents for your validation report.  And then you would enter the reagent name, the manufacturer, the catalog number, and most importantly, the lot number, and the expiration date for each of your reagents, just as we've done already.  And again, you would click on the plus to insert that new information.

Then at the bottom, we have a notes section.  The notes section is for recording other information, most notably, what SOPs were followed.  So the SOPs can be as broad of a statement as, "testing was performed according to SOP in our laboratory".  Or this would be the opportunity to input information such as, "performed according to SOP XYZ", or "performed according to product insert date and number", as an example.  And then, as always, remember to click on save to save the notes.  And now all that information is saved.  This will help with your documentation when you're finished with your validation.

http://www.invitrogen.com/site/us/en/home/Products-and-Services/Applications/Diagnostics-Clinical-Research/Quality-Control-Clinical-Labs/Online-Tools-for-Peer-Comparison-and-Assay-Validation.html

The EZValidation™ Online Tool is a web-based program intended to assist laboratories meet their verification or validation requirements.  Laboratories are responsible for ensuring compliance with applicable international, national and local clinical laboratory regulations and specific accreditation requirements. 

©2011 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation and/or its affiliate(s) or their respective owners.

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