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Working checklist

Independent QC: define the evidence before production

How to agree validation scope, responsibilities and review evidence at the start of a work package.

Independent QC is useful only when its purpose, independence and evidence are defined. The validation approach should match the deliverable, risk and sponsor procedures—not rely on a vague promise that work will be checked.

Questions to resolve

  1. 01

    Identify which datasets, programs and outputs require independent validation

  2. 02

    Separate production and validation responsibilities where agreed

  3. 03

    Define acceptable comparison methods, tolerances and documented exceptions

  4. 04

    Use an issue log with clear ownership and resolution evidence

  5. 05

    Set release criteria and identify who gives final approval

QC depth, systems, documentation and release steps remain part of the agreed engagement scope.

Applying this to a live study?

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