Module 12 2019

Document Processes Best practice for Review and Approval process ➢ Identify appropriate reviewers and approvers ➢ Make sure reviewers can access correct version of documents ➢ Use tools to manage timings ➢ Be clear about which comments can be accepted/rejected without consulting reviewer ➢ Have a procedure for reconciling conflicting comments ➢ Have reviewer meetings to foster agreement

The Organisation for Professionals in Regulatory Affairs