Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.
Why Write Development Reports?
Many scientists are expected to write and review development reports, but do not understand their purpose, and give these tasks low priority. Reports are necessary to:
- accurately record what was known during development, and when
- document the science behind a patent application and provide technical review; to aid in preparation of the patent application
- prevent reinvention or repeat experimentation by documenting results in a central file
- summarize experiments and provide interpretations in support of patents, regulatory filings, and product claims
- meet regulatory requirements of recording a process history and history of change, with rationale
- ensure that material submitted for external publication is widely available internally, and captured in a filing system
Writing reports can also provide added perspective, stimulate new interpretations, and help an employee achieve a promotion or other career goal.
How to Make Writing Easier
Many activities compete for time and attention in the typical biopharmaceutical firm. You can encourage interest in writing by making sure scientists:
- recognize writing as part of their job
- understand company expectations for quality, quantity, style, and time frames
- understand deadlines, and know there will be consequences for not meeting them
- receive training
- do not procrastinate, which can lead to decreased standards as deadlines approach
First, Align the Team
The single most important action you can take to facilitate writing is to assemble the team of authors (and reviewers) and talk about challenges, problems, and potential solutions. Ask the following questions:
- Why are we writing these reports?
- What barriers and obstacles are in the way for authors? For reviewers?
- How can reviewers make it easier for authors?
- How can authors make it easier for reviewers?
Often, a simple list of ground rules can be generated and agreed upon, such as establishing deadlines and managing expectations
Tools of the Trade
Writers and reviewers should be trained and provided the tools of the trade. Training can be done individually or in groups.
Table 1. Typical gripes about reports