I Missed the Boat, Now I’m Swimming Very Choppy Waters
All Situation Room examples are constructed and not descriptions of actual events.
Published on: March 28, 2026
Walter Routh
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What is the stability situation?
In 2019 our QA director (my boss at the time) pushed to modernize the stability program that I manage by having me create a digitalization proposal for funding from upper management. Begrudgingly among all the other work on my plate I put one together without any of the necessary political campaigning, so the funding was denied. Fast forward 6 years and we received three audit observations regarding our tracking and trending of data, verification of data entries, statistical analyses and charts and data integrity issues surrounding all of that.
We committed to the agency to modernize, which to me means digitalize—connecting all data in one system from release testing to the final stability interval. Tables are turned and upper management is asking why I haven’t made these improvements sooner. I’m scrambling under job jeopardizing scrutiny to figure out what we need—software options and costs, expected resources for implementation and so many other complex unknowns. How can I unjumble so many options available in the Stability LIMS market?
How should this be resolved?
It sounds like you’re getting ahead of yourself, worrying about costs and resources before you’ve nailed down user requirements. First, drop everything and focus on that. Take a tour of a few stability programs that have digitalized and then sit down with a group of knowledgeable people to make a list of everything you’d like your new system to do. You’ll at least gain a vision to move forward—your vision, not the auditor’s.
We Want to Hear Your Thoughts!
February 28, 2026
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Share your questions and experiences
A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
