By the Book: Documentation Requirements in TrackWise
For pharma, CROs, and other the life sciences; even the most useful quality-management tools—such as TrackWise—aren’t without caution and concern. Large system and process-level configurations require large documentation—and it’s important to keep it all in order.
Currently in widespread use, TrackWise is a robust system that’s proven flexible enough for different processes through standard configurations. However, the typical number of configurations for most applications runs in the thousands—if not the tens of thousands.
Multiple Processes, Multiple Concerns
Multiple process configurations require significant documentation. That’s a challenge when it’s time to validate your system and prove due diligence. I frequently see this issue when processes share configurations at the system level—but not at the process level.
Figure 1: Capturing configuration in Excel provides an easy way to search and filter configuration.
For most, this becomes a problem during maintenance releases—when only certain portions of the configuration need re-testing. As maintenance releases can occur many times during the year, it’s always important to find ways to reduce the time spent on validation.
TrackWise Users Take Note
Two options are documentation maintained as MS Word or Excel documents. For large configurations, Word documentation can run 2,500 pages. Put in perspective, the unabridged edition of Stephen King’s The Stand—a heavy book considered a daunting read—is 1,152 pages. This poses a problem when you must review and edit with each release.
In contrast, Excel documentation typically results in smaller, easier-to-manage documents that you can generate using standard database tools. This can reduce revision time and ensure accuracy, as documents are generated directly from the system. Sorting functions make it simpler to identify documentation changes—useful when you move configurations between environments. This can drop the time for documentation review from weeks to days.
Figure 2: Separating documents into System Level & Process Group configurations gives several benefits.
Enjoy the Real-World Benefits
To manage multiple process configurations; one approach is to maintain separate documents for system and process-level configurations. This requires one system-level and one process-level document for each process managed. This provides clear separation between system and process-level configurations. It also allows only process owners to review and approve configurations. The result is documents that are hundreds—not thousands—of pages. That makes revision quicker and more accurate.
The bottom line? While there’s no “perfect” way to document, some approaches may prove more costly and time-consuming than others. Don’t be afraid to adapt your approach to documentation as needed. You, your department, and your organization only stand to gain. The method takes a backseat to your due diligence… so do what works and be thorough.
My focus and experience is implementing advanced Quality Management solutions that help life sciences organizations better manage their IT systems with compliance and efficiency. In my future insights, I will share additional tips and use cases.