Module 12 2019

Document Approval Best Practice

Revising an approved document ● An approved document is an official company record – must be retained ● Must be significant issues with scientific content to justify revision ● Create a new draft document for revision from the original approved document ● Revise, review, QC and approve Other options ● To correct an error create an erratum ● To add new information create an addendum

The Organisation for Professionals in Regulatory Affairs