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Method Validations

The Method Validations page holds, per method, the evidence that it performs correctly in this laboratory's hands (ISO/IEC 17025 §7.2). It is the record an assessor asks for by name under §7.2.2.4.

Found under: Analysis Configuration → Methods & Analyses → Method Validations.

Toolbar

ButtonAction
Add — Create a new record
Columns — Show/hide table columns
Filters — Open/close the filter panel. A red dot indicates active filters
Export CSV — Download table data as a CSV file
Orientation — Toggle between portrait and landscape printing
Print — Generate a PDF of the current view
Help — Open the help dialog
Search — Quick search through table data

Record Actions

Clicking the icon on each row shows:

  • Edit — Open the edit form
  • Delete — Delete the record (with confirmation)

The three types

TypeWhen it is used
Verification (external)§7.2.1.5 — the method is fully validated by others and the laboratory proves it can execute it correctly
Validation (lab-developed)§7.2.2 — the method was developed in-house, is non-standard, or has been modified
Revalidation§7.2.2.2 — the same method is re-tested after a substantive change to the procedure, instrument, analyst or matrix

Fields

FieldDescription
MethodWhich method — required
TypeOne of the three above — required
StatusDraft, In Progress, Approved, Expired or Superseded
Validation DateWhen the work was done — required
Performed By · Approved ByWho did the work and who approved it
Next ReviewWhen it is reconsidered
ScopeWhat the validation covers
Parameters TestedWhich performance characteristics were examined — see below
Acceptance Criteria · ResultsWhat was required and what was found
Fitness StatementThe explicit statement that the method is fit for its intended use
Controlled Procedure DocumentThe validation procedure from Document Control (§7.2.2.4(a))
Certificate URL · NotesPointers and remarks

The hint on Parameters changes with the method: for quantitative methods it suggests precision, trueness, LOD, LOQ, linearity, range and robustness; for qualitative examinations it suggests sensitivity, specificity, and false positive and negative rates.

What blocks approval

The status Approved cannot be set while Results or the Fitness Statement are empty — they are the two halves of §7.2.2.4(d)-(e).

Beyond that, you cannot approve your own work: if you are the person who performed it, approval is refused.

Automatic revalidation drafts

You do not have to remember when a revalidation falls due. A draft Revalidation is created automatically when:

  • a method's procedure version changes, or
  • a Change Request against the method moves to Implemented.

The scope is pre-filled with the reason that prompted it.

Connects to

Points at — this page does not stand without these:

Notes

  • Recording requires a live authorisation for the Method Validation activity in User Competencies, where the laboratory has defined such a requirement.
  • The date filters are labelled Created From/To but filter on Validation Date.
  • See also: Methods, Change Requests.