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Form · VAL-F09

Mapping Study Deviation Report

Deviation from protocol, impact on study validity, and approval.

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Purpose

Records a deviation from an approved validation or mapping protocol during execution: what deviated, why, the immediate action, the assessment of impact on the validity of the study or qualification, the decision (accept / repeat / fail), CAPA and approvals.

What it covers

  • Authorisation

How to complete it

  1. 1.Raise at the time the deviation is identified; number DEV-YY-NNN and reference the protocol and step.
  2. 2.Describe factually; attach evidence; state the immediate action (for example study continued / paused / sensor replaced).
  3. 3.The Validation Lead assesses impact; QA decides whether the study remains valid, must be partially repeated, or has failed.
  4. 4.Record any change required to the protocol for future studies and the CAPA reference.

Before you use it

  • Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
  • Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
  • Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
  • Record the document in your own document register and set its review date.

Related documents

This is an original template published by ValiTrac. It does not reproduce the text of ISO/IEC 17025 or of any accreditation body publication, and it does not by itself confer or guarantee accreditation. Customise, review and approve it before use.