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How to Write an Auditor-Friendly Validation Summary Report (VSR)

Has this ever happened to you? You’ve finally reached the end of a validation project. At this point you’ve spent hours planning, testing, resolving non-conformance and issuing documents. Now all that is left to do is write the summary report and you find yourself with writer’s block!

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Where do Annex 11 and Part 11 intersect?