Editing to Produce Audit-Ready Documentation

Compliance with FDA regulations and other standards is often a necessity in medical writing. You can read my paper addressing editing in regulated industries. This paper provides strategies to help ensure that documentation is complete and in compliance with any required regulations or standards. I researched this topic by interviewing several of my colleagues, as well as conducting  extensive online research.

I have included this document in my portfolio to convey the following:

  • My understanding of the unusually high stakes associated with writing and editing for regulated industries
  • My knowledge of good editing skills in general, and my ability to use editing as a form of quality control
  • My ability to identify strategies for improvement
  • My ability to understand a particular audience (FDA auditors) and their strict expectations

Click here to view.

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