Module 12 2019

Document Approval Best Practice Approval ● No further changes needed to format or content ● Document should be final published version before approval ● Approvers have signed off on document content – No last-minute surprises ● Approval should be an administrative formality ● Signatures – Electronic signatures – 21 CFR part 11 – Handwritten signatures – Signature page(s)

The Organisation for Professionals in Regulatory Affairs