Change Control vs Validation Plan

For implementing new electronic lab notebooks to replace the existing paper forms, our project team is suggesting that the Change Control will act as a Validation Plan and that a stand alone “Validation Plan” document is not required.
Does this sound right?

This is in a pharmaceutical API facility.

Ideally, the Change control should be raised first,
Validation plan should be prepared as separate document…


  1. Change control is a QMS document.
  2. It is difficult to describe all the phases of qualification and validation in Change control.
  3. Change control only define the action plan and monitoring task as a brief.
  4. Responsibility and actions can be more clearly defined in validation plan.
  5. After completion of project summary report can be prepared, which will show a good documentation system.