Generating an SOP from a validation study

Turn a completed validation study and its package insert into a draft SOP, with any differences between your results and the insert confirmed first.

When a validation or verification study is complete, the procedure for running the test should reflect what your lab actually found. Legion Diagnostics can draft that SOP from the study itself.

Starting the draft

Open "Document control", then "Document drafts". Click "Create draft", choose "SOP", then choose "Use AI to help". In the form:

• choose the "Experiment" (only completed studies are offered)
• choose the "Package insert" for the assay, if it is not already on the analyte
• add the "Applicable analytes" and, if you use one, your SOP template

You can also ask the assistant to draft an SOP from a study.

Linking the experiment places the SOP under that study on the analyte's document trail, so an inspector can follow the line from validation to procedure.

What the draft uses

The draft draws on the study's results, such as the reportable range your linearity study verified, along with the manufacturer's package insert and anything in your template and reference files.

When your results differ from the insert

Before drafting, Legion Diagnostics compares the study with the package insert on the values an SOP states: the analytical measuring range (lower and upper limits), the limit of detection, the limit of blank and their units. If any differ, the assistant lists the differences and asks which value the SOP should use. Your study's value is the default, and drafting starts only after you confirm. This keeps a manufacturer's figure out of a procedure your lab has not verified.

Then review and approve

The draft is written in the background and opens in the document editor. Review every section, then submit it for approval as described in Approval workflows.