Checklist For Risk Management In Document Reviews

Product development—whether in the pharmaceutical, biological, or medical device sectors—demands the strategic and efficient use of both time and human resources to produce high-quality documents for regulatory submission. A central figure in this process is the Medical Writer, who plays a pivotal role in coordinating the efforts of various contributors to ensure the timely and accurate development of required documentation. As the complexity of document creation increases, so too does the number of individuals involved in content generation, review, and resolution of queries. This growing collaboration introduces a heightened risk of "document chaos," characterized by multiple conflicting versions, an overwhelming volume of comments and edits, and unresolved team queries. These issues can significantly compromise document quality, inflate costs, delay timelines, and strain human resources.

To mitigate these risks, it is essential to implement structured processes and tools that promote clarity and control. The Ideagen PleaseReview system provides real-time visibility into the document under review, which enables closely monitored team contributions and efficiently summarizes progress during review cycles.

Discover more about the common risks and associated consequences related to document development by accessing the infographic.