In a world full of complicated science, medicine, and regulation, internal document signoff and approval are key to your company's success. Inefficiencies in the review and approval process can easily double or triple the cost of a final document. Following are some tips for an effective document review process that can save money, your job, and your sanity:
- Discuss with your team the goals of a document or study before the writing begins. Ideas often change as a document develops, but begin the process with some clear thinking in mind.
- Have a plan for document development and review, including who will review what sections, for what purpose, and by when. Make sure your plan includes people from all required and relevant departments and areas of expertise.
- Have all key people review the document in advance of any planned document review meeting.
- Allow enough time for the document coordinator or medical writer to review the team's comments before any required document review meeting. Have the writer or coordinator triage comments and identify issues requiring discussion or clarification. Use this triage to serve as the basis for the next step of the review process.
- Based on the triage of comments performed in the previous step, create an agenda for any required document review meeting. An agenda usually leads to a better outcome than a page-by-page document review. While appropriate in some circumstances, page-by-page reviews too often get bogged down discussing minor grammatical and typographical errors at the expense of more substantive issues.
- Circulate the agenda in advance of the meeting, to allow all team members to see all key issues before the meeting begins. Allow team members sufficient time to review all issues and formulate their individual positions on each issue.
- Consider not having a review meeting if one is unnecessary and if your company's SOPs allow you to skip this step. If the team's comments are straightforward and easily addressed, your team will probably be grateful not to attend yet another meeting.
- Find a strong facilitator who can guide your team through the process and coordinate consensus. The medical writer or document coordinator may serve this function, or someone else may be more suited to this role. Strong facilitation can help resolve controversy and achieve document approval.